FDA Grants Emergency Use Authorization to Premier Medical Laboratory Services for At-home COVID-19 TestAssay designed for RapidRona at home tests see more
Premier Medical Laboratory Services (PMLS), one of the largest private medical diagnostics laboratories in the US has provided results for millions of COVID-19 tests since the beginning of the pandemic, contributing largely to the national COVID-19 response. They have also implemented one of the largest variant surveillance initiatives in the country with the capability to sequence up to 42,000 specimens per day. Now, they have been granted Emergency Use Authorization (EUA) from the Food and Drug Administration to process results for at-home COVID-19 tests.
The RT-PCR-based SARS-CoV-2 assay now authorized by the FDA is designed for RapidRona at home tests which can be ordered online at www.rapidrona.com. RapidRona enables those who would like to test for COVID-19 to collect their own sample at home by a minimally invasive nares swab and then send the specimen with prepaid shipping to the lab for processing of results. Polymerase Chain Reaction (PCR) tests have been known throughout the pandemic as the gold standard of testing methods due to the highly accurate results that they provide.
“Our scientists have worked diligently to take the steps necessary in receiving the EUA for this test,” said Kevin Murdock, Founder and CEO of Premier Medical Laboratory Services. “We did this because we know how important it is to enable the population to more easily access reliable COVID-19 tests with fast turnaround times from home. We’re proud that this is another way we can provide effective solutions for COVID-19 management.”
At-home COVID-19 tests have been reported as difficult to find during the Omicron surge. The EUA attained by PMLS will allow more people the ability to test and mitigate the spread of the virus. Because some countries around the world only accept incoming travelers who have taken a RT-PCR test with a negative result, RapidRona is the choice for at-home testing among travelers. Returning schools and businesses can also reduce viral transmission rates utilizing RapidRona’s sample collection method designed for improved comfortability, keeping infected employees, students, and staff to a minimum.
PMLS is part of a house of brands under Diversified Medical Healthcare which manufacture testing supplies, develops medical data management software, and provides PPE to seamlessly meet the needs of organizations without delay or disruption.
During the pandemic, PMLS has:
- Processed millions of COVID-19 tests with a turnaround time of 24 hours or less
- Served as the choice processing lab for Health and Human Services testing sites
- Been the trusted COVID-19 management partner for professional sports teams, schools, colleges, large corporations, and health departments spanning from coast to coast
ABOUT PREMIER MEDICAL LABORATORY SERVICES: Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS), easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry and patient-friendly billing. Their expansive testing menu includes advanced Cardiovascular Testing, Diabetes panels, Pharmacogenomics, COVID-19 testing, Women’s Wellness panels, Allergen Specific Ige Blood Testing, and Toxicology. For more information, please visit www.PreMedInc.com or call 1.866.800.5470.
When it came to vaccine distribution, Softbox saved the day. see more
When a pneumonia and meningitis immunization program needed to be rolled out worldwide, the safe transportation of vaccines was a crucial component in the process.
The global bio-pharmaceutical company leading this initiative required a totally reliable, cost-effective Temperature Control Packaging solution to support its drive – and one that was ideal for air transportation.
The award-winning Softbox Silverpod® range was tailor-made for just this kind of activity. Not only was the entire global distribution program completed, but it was done so without any product excursions whatsoever.
Premier Medical Laboratory Services, in Partnership with the Clemson University, Reports Omicron Variant Now Present in Upstate, SCPremier Medical, Clemson detect latest variant in Upstate region see more
December 20, 2021 – Today, Premier Medical Laboratory Services (PMLS), headquartered in Greenville, SC, reports their findings that the Omicron variant is now confirmed to be present in the Upstate. The laboratory has been surveilling for Omicron and other novel variants through Next Generation Sequencing (NGS) in partnership with the Clemson University Bioengineering Department. Clemson University REDDI Lab has collected samples for COVID-19 testing from throughout the upstate community and was funded through the National Institutes of Health (NIH) to then have the COVID-19 positive specimens undergo NGS at PMLS. NGS is the process of decoding the genetic make-up of the virus to track how it is mutating and spreading throughout the population.
“As a proactive and solutions-driven company, we implemented Next Generation Sequencing to meet the needs of our population with preparedness for novel variants like Omicron,” said Kevin Murdock, CEO and Founder of Premier Medical Laboratory Services. “Through partnerships like ours with Clemson University, we are happy to increase the amount of data for South Carolina and the entire nation which is vital for vaccine efficacy and our understanding of the virus.”
Knowing the importance of accumulating data in the continued fight against the pandemic, PMLS implemented one of the largest sequencing initiatives among any lab in the nation – with the capability to sequence up to 42,000 samples per week. Many labs that are conducting COVID-19 testing have not developed the capabilities to conduct sequencing, and new variants cannot be fully identified via COVID-19 diagnostic testing methods alone. PMLS will continue working to uncover any further novel variants and mutations that COVID-19 presents and notify health officials.
Other ways PMLS has helped to meet demands during the pandemic:
- Processing lab for Human Health Services surge sites and several state health departments
- Blue Cross Blue Shield preferred COVID-19 testing lab in several states
- Reached one of the highest testing capacities in the nation with the capability to process over 300,000 tests per day
- Developed medical data management software that communicates directly from laboratory equipment for faster HIPAA compliant delivery of data to healthcare providers and patients
- Shifted production to add in-house manufacturing of COVID-19 testing kits
- Donated thousands of COVID-19 tests to children's diabetes summer camps throughout the nation
- Donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic
For more information, please visit www.premedinc.com or call 1.866.800.5470.
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and highly advanced diabetes test, MDDiabeticPro. For more information, please visit www.PreMedInc.com
SCRA makes third investment in Zylo Therapeutics see more
South Carolina Research Authority (SCRA’s) investment affiliate, SC Launch, Inc. has made its third investment into Zylö Therapeutics, Inc. This $300,000 investment will help the company continue providing therapeutic topical solutions.
Zylö Therapeutics became an SCRA Member Company in 2018 and received a $21,500 Project Development Fund Grant. They also received a $41,000 SBIR/STTR Matching Grant in 2020. Zylö also became an SC Launch, Inc. Portfolio Company in 2019 when they received their first investment of $200,000. They also received a $182,500 investment as part of SC Launch, Inc.’s pandemic funding round to startups providing COVID-19 solutions.
Zylö developed a sustained-release drug delivery system that uses patented xerogel-derived particles, called Z-pods™, to topically deliver Nitric Oxide and other notoriously hard-to-deliver therapeutic agents. The technology enables a product concept called the Patchless Patch™, an innovative, competitive response to a lidocaine patch.
SCRA Investment Manager Steve Johnson said, “Technology applied to health care challenges is a powerful tool and the Zylö Z-pod® delivery system is creating value not only in health care but in a wide range of applications, from medicine to agriculture. These solutions have the potential to benefit us all.”
Founder and CEO Scott Pancoast said, “We knew we discovered something special with our breakthrough delivery technology. The highly engineered silica-derived Z-pods enable us to improve performance of a wide range of payloads. Our success is changing the way treatments can be delivered via the skin, providing sustained release with fewer systemic side effects. The teams at SCRA and SC Launch, Inc. continue to be trusted partners, and we’re glad they are on this journey with us.”
Scott Pancoast was a recent guest in our CEO Podcast Series. Listen to learn more about Zylö’s progress with silica particles, Nitric Oxide, and other developments for medical treatment solutions.
“The list of health care conditions to be treated by Zylö’s developments continues to grow. They are pursuing solutions to help patients with lupus, hair loss, joint pain, and even burns, just to name a few. Their commitment to innovative treatment discoveries have set them on a path of continued growth and success. We’d excited to have them in our portfolio of companies,” said Bob Quinn, SCRA Executive Director.
About SC Launch Inc.
Established in 2006, SC Launch, Inc. is the investment affiliate of the South Carolina Research Authority. The independent nonprofit corporation provides loans and investments to selected South Carolina-based companies participating in the SC Launch program.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, South Carolina Research Authority (SCRA) fuels South Carolina’s innovation economy through the impact of its four programs. SC Academic Innovations provides funding and support to advance translational research and accelerate the growth of university-based startups. SC Facilities offers high-quality laboratory and administrative workspaces for technology-based startups and academic institutions. SC Industry Solutions facilitates and funds partnerships between and among startups, industry, and academia. SC Launch mentors and funds technology-based startups that may also receive investments from SCRA’s investment affiliate, SC Launch, Inc.
The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?Long term impacts of COVID-19 across the health care spectrum are still to be determined see more
Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the diagnosis, treatment, and prevention of such diseases and medical conditions. Clinical research is the underlying process that results in the development of ground breaking new drugs and treatments that cure or treat diseases that improve all of our lives. One of the best and most recent examples of the importance of clinical research is the development of vaccines for the COVID-19 virus which to date has taken the lives of over 5 million people across the globe since early 2020.
The impact of the COVID-19 pandemic on the clinical research industry has been profound and in some respects may prove to be an inflection point for the Life Sciences industry.
The COVID-19 pandemic created massive disruption within the world of clinical research. In 2020, over 79% of ongoing clinical trials were disrupted in one way or another by COVID-19. The disruptions ranged from stopping ongoing trials, pausing recruitment of ongoing trials and pausing the development of new clinical study sites. Enrollment in clinical trials dropped dramatically during the early stages of the pandemic as potential participants were reluctant to make trips to hospitals or other research sites. In addition, many investigators, sub-investigators, and research staff had to shift focus to COVID related support instead of working on clinical research efforts.
Beyond the disruption to existing clinical research studies, however, COVID-19 has had other impacts on the clinical research industry that could have a potentially positive impact on how clinical research is conducted in the future.
COVID-19 Resulted in an Acceleration of the Clinical Research Process
When faced with the rapidly spreading COVID-19 virus, pharmaceutical companies and governments collaborated to accelerate the clinical research process in order to develop a vaccine that would work against COVID-19. Previously, the fastest a vaccine had been developed in the U.S. was four years when the vaccine for the mumps virus was developed in the 1960s. In light of the global health emergency created by the COVID-19 pandemic, researchers were able to reduce the normal time to arrive at a vaccine by years. How was this done? One of the reasons for the rapid development of the COVID-19 vaccine was the years of prior research on vaccine development for other viruses, like HIV. Researchers were also able to quickly determine the specific genetic makeup of the SARS-COV-2 virus by early 2020 and they used technology from RNA-based templates to develop a potential vaccine. Another important factor in streamlining the development for the COVID-19 vaccine was the hundreds of thousands of people who volunteered to participate in the clinical studies for the vaccine development. In addition, the U.S. Government implemented Operation Warp Speed which provided very large government contracts and research grants to pharmaceutical companies to research and produce vaccines. The U.S. Government also had the FDA advance all COVID-19 vaccine clinical research studies to the front of the regulatory approval line through the use of emergency use authorizations (EUAs). This lead to the development of multiple COVID-19 vaccines that were ready for mass distribution within 1 year of the identification of the COVID-19 virus, which is a remarkable accomplishment. The FDA also used EUA to expedite other responses to COVID-19 by approving new testing and additional sources and types of personal protective equipment (“PPE”). The development and distribution of the vaccine was a groundbreaking accomplishment that reflected the resilience and innovation of the clinical research industry. According to some clinical researchers, the rapid creation of COVID-19 vaccines is “a sea change in how to develop vaccines in the future.”
As we continue to work through the COVID-19 pandemic, it remains to be seen how much faster future clinical research studies will be accelerated in the future based on our COVID-19 clinical research experience. The FDA is under both political and media pressure to accelerate its approval process because of the COVID-19 experience and the clinical research industry is looking at its normal processes to determine if things can and should be done in a different way in order to streamline and accelerate the overall process while at the same time maintaining safety and scientific integrity.
A New Focus on the Clinical Research Participant
Another potential change in clinical research that was caused in part by COVID-19 is an effort by clinical trial sponsors to focus more on the clinical trial participant and their experience during the clinical trial. This includes trying to reduce the administrative burden on clinical trial participants and making the process simpler and easier for participants to navigate. Clinical trial sponsors are also evaluating trials with more of a focus on quality of life for the participants and increasing the use of patient support groups or patient advocates so it is easier for clinical trials to recruit new participants and to keep the participants engaged throughout the life of the clinical trial.
Use of More Decentralized Clinical Research
A decentralized clinical trial (DCT) is defined as a clinical study executed through telemedicine and mobile /local healthcare provider processes and technologies that brings the trial’s activities to the patient at home rather than using the traditional model of bringing patients to a trial site. Because much of the world was in lockdown mode to deal with the implications of COVID-19, clinical researchers increased the use of DCTs during 2020. This included the use of more virtual encounters and technology to connect clinical trial participants with the investigators. It is anticipated that this will occur more in the future as researchers can gather better data when it is easier for patients to report the data. With DCTs, patients can report data via their smart phone or tablets from home instead of having to be physically present at a clinical research site. Use of DCTs is also seen as a successful tool in recruiting the appropriate patient populations by increasing both access to clinical trials and the overall diversity of trial participants. Having a diverse group of clinical trial participants can help ensure that the drug or device being tested is safe and effective.
Increased use of Digital Technology
The use of digital technology by patients and participants in clinical trials has steadily increased over the last several years. During COVID-19 and with the increase in DCTs, the use of mobile devices such as smart phones or tablets, digital wearables or other types of biosensors have steadily increased. The use of this digital technology provides clinical researchers with access to continuous data for longer periods of time and it is easier for clinical trial participants to use this technology on a daily basis without disruption to their daily lives. The use of digital technology has also increased the opportunity for clinical trial sponsors to obtain real-world data (RWD) and real-world evidence (RWE) from clinical study participants. This result stemmed in part from the FDA’s launch of a program focused on the increased use of RWD and RWE. This kind of information has been used to support clinical trial designs and studies to generate innovative approaches to clinical studies.
Is there a silver lining from COVID-19 when it comes to clinical trials?
The long term impacts of COVID-19 across the health care spectrum still remain to be determined, but one of the short term impacts of this global pandemic could prove to be potentially significant and positive changes in the way that the clinical research industry operates. These changes could lead to a faster clinical research process that embraces the use of new technology such as digital therapeutics and development of a broader and more diverse base of clinical participants.
For a look at the regulatory framework for clinical trials in the life science industry and the risks faced by companies within the industry – including a discussion of potential future changes caused by the pandemic – watch Nexsen Pruet’s on-demand webinar, “Understanding Clinical Research Framework and Challenges in the Life Sciences Industry,” presented by Matthew Roberts of Nexsen Pruet and Rakel Meir of Biogen.
GSSM Honors Dr. Delphine Dean of Clemson University with 2021 Randall M. La Cross Distinguished Research Leadership AwardDr. Delphine Dean of Clemson honored see more
The Governor’s School for Science + Mathematics (GSSM) was pleased to award the Fall 2021 Randall M. La Cross Distinguished Leadership Award to Dr. Delphine Dean of Clemson University at the 33rd Annual Research Colloquium.
Dr. Delphine Dean is the Rob and Jane Lindsay Family Innovation Professor of Bioengineering at Clemson University. Dr. Dean earned her B.S., M.Eng., and Ph.D. in Electrical Engineering and Computer Science from the Massachusetts Institute of Technology. She joined the Clemson University faculty in 2007. She is a member of the American Chemical Society, American Physical Society, Materials Research Society, Biomedical Engineering Society, Society for Biomaterials, American Society for Engineering Education, the Orthopaedics Research Society, and is one of the newest members of the American Institute for Medical and Biological Engineering’s College of Fellows. Dr. Dean is a recipient of the Class of ’39 Award for Excellence from Clemson University.
Dr. Dean’s Multiscale Bioelectromechanics Lab at Clemson University studies the mechanics and interactions of biological systems at the nano-to micro-scale using techniques like atomic force microscopy and mathematical modeling. Her research focus includes the nanostructure of cardiovascular cells and tissues, the effects of ionizing radiation, and the development of novel medical devices. These innovations include saliva-based blood glucose strips that can be read by a smartphone application and a biodegradable marker for tumor localization that reduces the cost of breast cancer surgery.
Many of the projects led by Dr. Dean address needs in under-resourced communities around the world – a commitment aligned with that of GSSM’s mission to develop “ethical leaders” prepared to take on “the world’s most significant issues.” These efforts include a breast pump with a filter to inactivate HIV in breast milk, basket-woven braces for neck injuries that can be produced and sold by local women in Tanzania, and a low-cost patient monitor that a hand crank can power.
In response to the COVID-19 pandemic, Dr. Dean led the establishment of the certified clinical diagnostic Research and Education in Disease Diagnosis and Intervention lab at Clemson, which is key to Clemson’s COVID-19 testing strategy, as well as providing testing for their surrounding community. She also led the Clemson COVID Challenge, an undergraduate research, and design challenge to address issues related to the pandemic.
A core element of Dr. Dean’s work has been to engage students below the graduate school level with challenging and meaningful projects. Dr. Dean has provided mentored research & inquiry experience to over a dozen GSSM students since 2008 and over 150 Clemson undergraduates through Clemson’s Creative Inquiry program. Current student projects include designing medical devices for the developing world, collaborating on biomedical engineering innovation with students in Tanzania, testing radiation for biomedical applications, using magnetic nanoparticles to reduce the need for arterial stent implants, and applying human factors engineering to medical device design.
The Randall M. La Cross Distinguished Research Leadership Award is presented to Dr. Dean by Dr. Tyler Harvey. Dr. Harvey is a GSSM Class of 2011 graduate. As a rising senior at GSSM, he conducted his mentored research & inquiry experience at Clemson University under Dr. Dean. He returned to Clemson, earning his B.S., M.S., and Ph.D. while continuing research with Dr. Dean. Dr. Harvey is currently a Lecturer in Bioengineering at Clemson University and has contributed to the development of GSSM Outreach & STEM Foundations programs.
Biotech startup receives top honors in category see more
Elastrin Therapeutics of Simpsonville, SC has been named winner of the 2021 InnoVision Award for Technology Development, organizers have announced.
Elastrin Therapeutics is a biotech startup with technologies to restore hardened and damaged arteries and tissue by targeting the elastic fiber that makes them work.
Founded by Mr.Douglas Mulhall, Dr.Naren Vyavahare, Dr.Charles D. Rice, and Dr. Mirko Stange, the SCRA Client Company has demonstrated proof-of-concept for a patented therapeutic compound that may provide needed repair and restorative function to lungs that have been damaged by the COVID-19 virus. According to Vyavahare, “Elastin is present in lung alveoli that are being degraded by enzymes such as neutrophil elastases and MMPs released by inflammatory cells in COVID-19 infection of lungs. Our elastin targeting nanoparticle can also target drugs to the lungs and prevent lung injury.
Nephron steps up to help state's most vulnerable see more
As children ages 5 to 11 become eligible for COVID-19 vaccines, Nephron Pharmaceuticals Corporation has announced the opening of a pediatric COVID-19 vaccine clinic at its vaccination drive-thru in West Columbia. The clinic is open Monday – Friday from 12:00 PM – 5:30 PM.
Nephron, in partnership with Dominion Energy South Carolina, launched a convenient drive-thru COVID-19 vaccination site earlier this year. The drive-thru is located on Dominion Energy property off of I-77 at Exit 2. In addition to providing the space for a drive-thru, Dominion Energy is also generously contributing power and logistics support.
As a part of its ongoing efforts to help respond to the COVID-19 pandemic, Nephron offers Pfizer and Moderna vaccinations to citizens, including those ages 5 to 11, who are eligible. This includes regular doses and boosters for adults, during regular hours, which remain Monday – Friday from 10:00 AM – 4:00 PM.
Nephron registered nurses and pharmacists are administering vaccinations, with assistance from Nephron CLIA-certified diagnostics lab employees.
COVID-19 tests are also available as a part of the drive-thru. Nephron established a diagnostics lab last year in order to conduct COVID-19 tests. Since opening the lab, Nephron has tested thousands of people across the state for COVID-19 – including employees, students, educators, athletes and families – as the company does its part to keep South Carolina healthy and safe during the public health crisis. The Nephron CLIA-certified lab procured state-of-the-art technology for COVID-19 real-time PCR testing and serological antibody testing. Results are delivered within 24-48 hours.
SCBIO Names Louisiana Economic Development Executive James Chappell as CEO to Lead State’s Fastest-Growing IndustryGoal to “take South Carolina life sciences to an entirely new level” see more
Following a nationwide search that targeted 200 candidates in 39 states and resulted in 116 total applications from across the country, the Board of Directors of SCBIO has named James Chappell, an executive with Louisiana Economic Development, as the organization’s new President and Chief Executive Officer.
Dr. Chappell, whose career also includes time with Chartic Management Consulting in Boston, joined Louisiana Economic Development (LED) in 2013 and held positions of increasing responsibility at the organization including Executive Director of State Economic Competitiveness before being named Executive Director of Competitiveness and Entrepreneurship for the organization in 2021.
During his tenure at LED, Dr. Chappell’s numerous successes included designing and implementing the state’s $100 million venture capital and small business funds, developing strategies to recruit globally recognized companies to the state , and joining the Louisiana MediFund board to develop strategies to increase the biosciences and healthcare industries in Louisiana. He also collaborated with bioscience and technology advocates to improve incentives to promote growth in the bioscience and technology industries.
Dr Chappell earned his B.S. and M.S. in Plant Environmental Sciences from Clemson University, his Ph.D. from Louisiana State University, and a Postdoctoral Fellowship in Stem Cell Biology focusing on cancer and diabetes from Harvard Medical School. A three-year varsity football letterman while at Clemson, he is married with two children. He will begin his new role with SCBIO starting November 8, 2021.
“SCBIO and South Carolina life sciences are excited to welcome James to lead this dynamic and forward-looking industry organization, and to help our hundreds of life sciences companies and thousands of employees and innovators take it to an entirely new level,” said Lou Kennedy, Board Chair of SCBIO and founder and CEO of Nephron Pharmaceuticals, and a member of the search committee. “Competition for the position was extremely strong but we unanimously felt that his credentials in both life sciences and economic development were the precise mix we sought as we continue to build, advance and grow the industry in South Carolina.”
Life sciences has a $12 billion economic impact in the Palmetto State, with more than 700 firms involved and over 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental, and agricultural biotechnology products. It also represents a significant economic development focus for the state, led by the South Carolina Department of Commerce and other regional economic development teams.
South Carolina life sciences has seen a near-doubling of firms and 40% increase in life sciences’ direct employment since 2017, which combine to make it the fastest growing industry sector in the state, according to data provided by Dr. Joseph Von Nessen, state research economist and noted economic development expert with the Moore School of Business at the University of South Carolina.
“As a South Carolina native, I am thrilled to join SCBIO and return home. South Carolina has become an emerging leader in life sciences, and I am excited to continue SCBIO’s great work in helping to grow the life sciences industry,” noted Dr. Chappell.
Ms. Kennedy went on to thank SCBIO Interim CEO Erin Ford for her critical contributions in leading the organization during the search process, which began in May with the resignation of prior CEO Sam Konduros.
“Erin continued to do a strong and stellar job in leading the organization, charting the path, and maintaining the momentum without missing a beat during this national search, and our board and membership are grateful to her. The entire board and SCBIO membership are excited that she will remain a key part of the organization in her prior role of Executive Vice President and COO to add a steady and experienced hand to crafting an exciting new future.”
Ms. Ford has served as primary lead for SCBIO’s business operations and finances, championing investor relations and existing industry strategies, and spearheading integrated marketing initiatives. She has managed the majority of the organization’s day-to-day requirements since joining SCBIO in 2017.
Since 2017, SCBIO has more than tripled membership and quadrupled revenues, implemented a strong economic development focus, and launched a new innovation platform. It serves as the voice of the life sciences industry, implemented a surging workforce development initiative and created ongoing programs to encourage participation by women in life sciences, to support diversity-equity-inclusion initiatives and to encourage student participation in the industry. The organization also successfully led industry and organizational pivots during the COVID pandemic. In a recent executive order, Governor Henry McMaster authorized SCBIO and the state’s Commerce Department to work together to accelerate the onshoring and repatriation of the pharmaceutical industry and vital PPE products and technologies to South Carolina.
For additional information on SCBIO, please visit www.SCBIO.org.
Vigilent Labs Relocates to New Charleston, SC Facility to Meet Demand for COVID-19 Test Kits see more
RYSE Asset Management, a United Kingdom-based global financial investment firm, has listed Vigilent Labs as an investment opportunity. RYE Asset Management invests in early-stage health data technology firms that demonstrate promising growth on a global scale. RYSE connects high-potential healthcare firms with established global distribution partners.
The announcement came as Vigilent Labs announced the relocation of its Headquarters from the Charleston Navy Yard to 3860 Faber Place Drive, North Charleston. The 10,000 square feet of office and light manufacturing space will serve as its headquarters and East Coast manufacturing operations site to streamline with its international partners, SeroClinix and UniBiosciences (UBS), and meet the increasing demand for COVID-19 Antigen and Antibody test kits worldwide. Vigilent Labs is an advanced health and medical technology company providing solutions for the detection and identification of health and bio threats and diseases.
Established in 2019, the company has an internationally renowned team of medical scientists, healthcare physicians, and business executives. The company offers FDA/EUA approved COVID-19 (and its variants) test kits, Influenza A, Influenza B, and Norovirus, and more.
Vigilent Labs’ technology is unique, because test results can be loaded onto their proprietary v. Labs Platform© (VLMS), and leverage its v. Resolute Reader, lab in your hand that provides rapid and accurate screening results.
John Falk, Founder & President of Vigilent Labs said, “We are beyond thrilled to have been listed by the prominent financial firm RYSE Asset Management; while, at the same time, our Leadership Team and Board has made the strategic decision to locate closer to the Charleston Airport opening other logistical channels for the current and future production and distribution of our test kits and devices throughout the United States and around the globe.”
To learn more information: www.vigilentlabs.com
To learn more information: www.ryseam.com
PMLS picks new Chief Commercial Officer for fast-growing organization see more
Premier Medical Laboratory Services (PMLS) is announcing today Jeff Schmalz as their new Chief Commercial Officer. At PMLS, Jeff will be focusing on the major disciplines impacting lab growth including partnerships, product development, clinical outreach, sales infrastructure, customer service and marketing. With 35 years of experience in multiple healthcare organizations, he brings extensive knowledge in the diagnostics and reference lab markets.
In his latest role, he led the segment marketing and business development team responsible for integrating specialty labs, technology, and test launches that contributed to several hundred million in additional revenue growth. Jeff also oversaw the launching, branding, and commercializing of Lab Developed Tests (LTDS) over a period of 15 years for 25 test classes resulting in over $400M per year in revenue. He has founded, developed, and launched international partnerships to carry out his sales initiatives and maximize overall market share.
“I chose to work at Premier Medical Laboratory Services because they’re an innovative and nimble company with all of the components in place to make them a national leading specialty lab,” said Jeff Schmalz. “They lead with a forward-thinking approach to unmet needs within the healthcare industry and continually build on their capabilities to bring the most advanced medical diagnostics services for better patient outcomes…and that’s something I want to be a part of and advance forward.”
As a graduate and scholarship athlete from the University of Maryland, Jeff pursued an executive management MBA curriculum from the Kellogg School of Management. Since then, he has served as a board member for the Biomedical Marketing Association and successfully launched products at Abbot, Chiron, LabCorp, Digene, Bayer and Qiagen. He managed a team of 53 segment leaders, product managers, and marketing communication strategists by positive motivation, leading by example, and empowering them to make decisions and take initiative.
“We are at an integral phase in our growth here at Premier Medical Laboratory Services as a top lab with the mission to bring the most advanced diagnostics to our nation,” said Kevin Murdock, CEO and Founder of PMLS. “The level of talent and experience that Jeff Schmalz possesses will help us tremendously in fulfilling our vision of improving patient lives.”
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DIABETESPredict. For more information, please visit www.PreMedInc.com
Upstate company makes its mark see more
Ahh, that fresh, crisp aroma of a craft beer — your tongue tingles at the first whiff. The concoction in question may have the fragrance of a “juicy, double-dry-hopped IPA,” a popular locally brewed label on tap here, but Do-Not-Drink-This-Stuff. It’s hand sanitizer.
“It was like, wow, this stuff actually still smells like Bluprint, one of our IPAs,” says Shawn Johnson, co-owner of Birds Fly South Ale Project, which teamed with Parimer Scientific at the onset of the pandemic to make a pharmaceutical-grade product for local health care providers.
Which is why the South Carolina Manufacturing Extension Partnership recognized Parimer last November with an SCMEP COVID-19 Response Award. In September, the South Carolina Research Authority bestowed Parimer a coveted “Member Company” status, noting that the company shipped more than 10,000 pharmaceutical units in 2020.
Dick Pace, 33, owner and principal scientist, launched the company three years ago. Today, Parimer, which is known as a “contract research organization,” provides turnkey chemical solutions, custom compounds, polymers and way more complicated stuff, along with R&D.
Customers, so far, have included farmers and academia and now Big Pharma, Pace says. Within six months, Parimer was operating in the black and has grown from its $3,000 in startup costs to more than $600,000 annually, he says.
Mike Klepfer, Parimer’s vice president of business development, joined the company in July. The Air Force veteran, who has lived in the Upstate for 21 years, has worked for the likes of Bayer and Merck.
After the pandemic forced Klepfer to close his 4-year-old executive-recruitment shop, he arrived at Parimer when the company’s year-over-year growth was already around 25%, he says. Now, with mega-deals in the pipeline from marquee companies — all under non-disclosure agreements — he sees near-term growth upwards of 100%.
Quite a pace for Pace, who found himself overqualified to work as a scientist in his native Greenville after earning his Ph.D. in bioengineering from Clemson in 2014. This even though he had already published at least nine papers and presented at conferences from Denver to Paris. He also worked at the French version of the U.S. National Institutes of Health (he speaks fluent French) and on NIH and Department of Defense grants, among other accomplishments.
“We are excited to partner with Parimer on their growth path. The specialty laboratory services they are offer is unique to the Greenville area and they are one of only two operations in South Carolina approved as an active pharmaceutical-Ingredient manufacturer. ” — Steve Johnson, South Carolina Research Authority investment manager
He applied for 250 jobs. Two companies responded, he says, their highest salary offers coming in at $35,000 a year. “I felt that I had skills to offer, but I wasn’t able to market those, and the pay rate is so low for Ph.D. scientists, so I thought, how hard would it be to make $40K on my own?” Now he hires young scientists in similar straits, while he also avoids the entrepreneurial pitfalls — and failures — he saw in multiple life sciences startups.
“People were buying this extremely expensive equipment and they were having to hire scientists to run it,” he says. “And almost always, the senior owners of these companies were venture capitalists.”
Among his hires is Victoria Bobo. In 2015, she earned a bachelor’s degree in chemistry from Converse College (now University), then her Ph.D. from the University of South Carolina in 2020. Like Pace, she wanted to stay and work in her native Upstate.
“I had the misfortune of graduating during the pandemic when no one was hiring,” says Bobo, 28, who joined Parimer after sending out, according to Pace, some 150 job applications.
Bobo is Parimer’s “Quality Chemist.” But like her three colleagues at the Easley lab, she does everything else there, too.
As Klepfer says, “We all take the trash out each week and we vacuum the floors and clean the lab and do all the stuff that needs to be done to maintain the business.”
“We’re totally happy,” Pace says. “It’s doing what we’re doing and not making, you know, $300K. Maybe one day, but not yet. I started this to basically provide myself a job, and now we’re able to provide others a job, and that’s really, really rewarding.”
The quick Pace of delivering FDA-grade hand sanitizer
Dick Pace recalls driving to Birds Fly South Ale Project at the outset of the pandemic to load his truck with 500 gallons of beer and bring it to his laboratory.
At Parimer Scientific in Easley, where he is owner and principal scientist, his team concocted a hand sanitizer that would meet FDA specifications for use in hospitals—at a pharmaceutical strength the agency categorizes as an over-the-country drug, Pace says.
After winning FDA approval in just two weeks, Pace began frequenting Ace Hardware and Home Depot to build his own production line for distilling BFS’s beer to 95% alcohol, bottling the new product, labeling and shipping it.
In roughly five weeks, with everyone scrambling for the stuff, Birds Fly South sold Parimer, at cost, somewhere around 180 barrels of nearly expired beer, says Shawn Johnson, owner of the Hampton Station craft brewer along with his wife, Lindsay.
Pace says the two businesses—emphasis on local—churned out some 30,000 bottles until the big manufacturers finally stepped up.
A bunch of those containers went to Greenville Office Supply. Turns out, McLain Scales, the venerable company’s Director of Sales-Janitorial and Facility, grew up with Pace.
GOS couldn’t sell below-FDA-grade product to its hospital clients and first-responder customers, among others, he says.
“So we had to get creative with our partners, and fortunately Parimer Scientific had all the knowledge on how to manufacture it,” he says, adding that GOS ultimately sold more than 6,000 Parimer bottles — complete with the Birds Fly South logo.
The Johnsons credit Parimer with helping keep their business afloat and some of their employees employed. They could also sell two-ounce bottles, which Parimer provided at cost, Lindsay says.
Of Pace and their brief stint as hand-sanitizer partners, Shawn says, “It’s a testament to ingenuity — he’s an incredibly smart man — and to the agility of small business and the connection to the community.”Parimer Scientific’s team says their equipment room is one of the best equipped labs in SC, but to the untrained eye it doesn’t look like much. However, they are able to take any product or chemical and reverse engineer it to figure out exactly what it makes up.
Pace’s Parimer People
Mike Klepfer, vice president of Business Development
Worked in biotech, pharmaceuticals and medical device companies. Sales rep for such global med-tech giants as Stryker, Bayer and Merck
Five years in the Air Force, leaving as captain, serving as a supply and logistics officer. Citadel graduate, class of 1995
Victoria Bobo, quality chemist, joined Parimer in October 2020
Ph.D., Analytical Chemistry — University of South Carolina, 2020
Bachelor of Science in Chemistry, with a minor in Spanish — Converse College, 2015
Stephen Lee, Research Manager at Parimer since November 2020
M.S. in Chemistry — Georgia Tech, 2011.
Bachelor of Science in Chemistry, University of Wisconsin-Madison, 2009.
Adjunct instructor at Greenville Technical and Spartanburg Community colleges for more than a year each.
Work experience includes technical assistant at Milliken & Co. and certifying scientist at LabSource in Greenville, among others.
Womble Bond Dickinson provide insight into telehealth during the pandemic see more
- Telehealth greatly expanded during the COVID-19 pandemic, in large part due to regulatory waivers. Those regulatory waivers aren’t permanent, but lawmakers are evaluating ways to permanently expand some aspects of telehealth coverage.
- While the HHS OIG recognizes the importance that telehealth plays in our healthcare system and will continue to evaluate new telehealth policies and technologies so as to improve care, it will also strive to ensure that they are not compromised by fraud, abuse, and misuse.
- Through recent telehealth policies and funding, the government is working to improve healthcare equity and resources for telehealth.
While the COVID-19 pandemic remains a public health and economic concern, companies are adapting and adjusting, finding new and better ways to do business moving forward. Womble Bond Dickinson is taking a comprehensive look at this new Opportunity Economy from a wide range of viewpoints. Recently, Womble Bond Dickinson attorneys Alissa Fleming and Toni Peck explored the pandemic-inspired expansion of telehealth services and how such measures can benefit patients and providers alike moving forward. They recently spoke to Womble Bond Dickinson attorney Mark Henriques on an episode of the “In-house Roundhouse” podcast, and the article below is based on that conversation.
The telehealth boom during the COVID-19 pandemic impacted nearly every American. Changes made during the public health emergency promise to permanently transform the delivery and availability of healthcare. While these changes were made in rapid response to the pandemic, providers and patients alike discovered that telehealth—providing healthcare remotely via technology—offers advantages and efficiencies that make sense to continue even as the pandemic ends.
Healthcare is perhaps the most highly regulated sector of the economy, so extending telehealth post-pandemic will require regulatory reform as well as consumer demand.
The State of Telehealth in the Late-Stage Pandemic
Telehealth isn’t a new idea. As Peck said, “Prior to the pandemic, there was an interest from providers and patients, but there were restrictions and limitations that kept telehealth from being as popular as it currently is.”
For example, providers faced geographic restrictions for where they could serve patients. Only certain types of technology could be used. And only a limited number of telehealth services were eligible for reimbursement from Medicare, Medicaid and private payors.
A study published in JAMA Network Open found that telehealth services grew by 1,000 percent in March 2020 and 4,000 percent in April 2020, with in-person visits declining 23 percent and 52 percent respectively. Those numbers have evened out somewhat, Peck said, but telehealth use remains much more popular than it was pre-pandemic.
“One of the biggest things that has changed has been patient and provider attitudes—we’re more willing to use it,” Peck said.
Also, federal and state governments have lifted many of the previous geographic restrictions temporarily. Technology requirements have been relaxed temporarily to allow for the inclusion of Zoom, FaceTime, and other popular platforms. More services now can be reimbursed, prescription restrictions have been relaxed, and licensure requirements by state medical boards have been eased temporarily.
“Telehealth has been crucial in the past 18 months, especially in championing healthcare equity,” Peck said. “We are better able to reach underserved populations, including rural populations, with telemedicine.”
Not surprisingly, investors have taken notice. Venture capital funding for telehealth reached $15 billion in the first half of 2021, up from $6.3 billion in the first half of 2020.
The rapid increase in telehealth adoption wouldn’t have been possible without regulatory streamlining that came in response to the public health emergency.
“Before the pandemic, telehealth only covered about 100 service areas, primarily those serving beneficiaries in rural areas,” Fleming said. But in early 2020, the Centers for Medicare and Medicaid Services (CMS) expanded Medicare coverage by adding 140 additional services, regardless of location. This includes ER visits, occupational/physical therapy, hospital discharge day issues and other non-critical care services. Also, a much broader range of providers now may provide these services via telehealth.
“This expansion of Medicare and Medicaid coverage helped to spawn payment for telehealth by private insurance payers,” Fleming said. “In allowing this expansion, the government acknowledged the critical role telehealth plays in expanding healthcare access.”
What’s Next in Telehealth?
But while telehealth has played a critical role in expanding healthcare access during the pandemic, the scope of the relaxed regulations was not intended to be permanent. So when do waivers expire and will they be continued?
Fleming explained that currently, the waivers will stay in effect through the end of the public health emergency or the end of the year. “With the Delta surge and the additional challenges that have come this summer and fall, there has been no further extension of the timetable, but that’s not to say there won’t be,” she said.
Such an extension may have a broad base of support, but it won’t necessarily happen automatically or without additional change.
Over the past several years, federal regulators have scrutinized telehealth arrangements, with a particular concern about fraud and abuse. The pandemic waivers reduced red tape, but federal regulators remain concerned about potential fraud and abuse issues.
“It’s not as easy as we might hope to permanently remove some of the regulatory requirements relaxed during the pandemic,” Fleming said. “Depending on the regulatory concerns, we may not see it expanded on such a broad base as we are seeing during the public health emergency.”
Peck also noted that some waiver expansions will require Congressional action, not just administrative changes.
States also will play a role in the continued, permanent expansion of healthcare. Generally, state regulatory schemes are concerned with licensure and scope of practice issues, while federal regulations deal primarily with reimbursement and the prevention of healthcare fraud, abuse, and misuse. So reforming telehealth regulations will require both federal and state action.
“Some states have already made changes to their licensure rules,” Fleming said. For example, Florida has created a specific telehealth license which allows out-of-state providers to become licensed to provide telehealth services in the state.
“Hopefully, other states will follow suit. It could create a solution to the lack of certain specialists in particular areas,” she said.
The Biden Administration has been busy in addressing telehealth concerns. In August 2021, the Administration announced a $19 million investment in telehealth, going to 36 recipients serving rural areas and underserved communities. This grant money will fund:
- Telehealth technology-enabled learning programs., building mentoring capacity in underserved areas.
- Twelve regional and two national telehealth resource centers. These centers will provide resources, information and education on telehealth to healthcare providers.
- Evidence-based direct-to-consumer telehealth networks. Bypasses some of the service restrictions.
- The creation of telehealth centers of excellence programs. These centers will assess and improve services in rural and underserved areas with high disease and poverty rates. This work will include piloting new services and publishing research.
“This award money is exciting because it provides funding for the growth of the actual telehealth structure,” Fleming said.
Looking Ahead: The Near-Future of Telehealth
Of course, expanded access to telehealth services requires that patients have high-speed broadband internet connections.
“We assume that if telehealth exists that everyone can use it, and that simply is not the case,” Fleming said. Many remote rural areas, in particular, struggle with broadband access. The sweeping federal Infrastructure Investment and Jobs Act seeks to address this disparity by providing $65 billion to expand broadband infrastructure.
“The Infrastructure Investment and Jobs Act also has an expansion of Medicare for telehealth, especially for mental health,” Peck said. “A lot of literature coming out of the pandemic shows that the need for mental health has increased greatly, and telehealth is a good platform for mental health care.”
In July, CMS published its 2022 proposed physician fee schedule. The proposal includes extending telehealth services for certain mental health care through 2023 or even permanently. Fleming said this will remove many barriers for receiving mental health care.
“Studies have shown that over a third of the population lives in an area without mental health providers. There’s a real shortage of providers in this field,” she said.
Another change, in response to the opioid epidemic, is that CMS is proposing that the home can be a site for treating substance abuse disorders.
Finally, CMS is asking providers for data about Category 3 telehealth services. This class of services was created during the pandemic to designate healthcare services that can be provided temporarily via telehealth. CMS is now looking at whether there is sufficient evidence to support permanent telehealth coverage of those services.
“Reimbursement is critical because nobody is going to provide services if they aren’t paid for them,” Peck said.
Reimbursement is one of several complex issues that must be considered during any permanent extension of telehealth exemptions. For example, Peck said that if a matter can be resolved in a five-minute phone call, should it be reimbursed at the same rate as an in-office visit? Other challenges remain, including the low rates of telehealth adoption in low-income and low English proficiency communities.
But even with the challenges, Peck and Fleming believe telehealth will remain an important platform for delivering healthcare services, even after the COVID-19 pandemic recedes.
“All in all, if there’s one thing the pandemic taught us, it’s that telehealth is a viable option,” Peck said. “Perhaps not by itself—we need to look at how telehealth and in-office visits can work together. But telehealth is a way to have a more efficient, equal healthcare system.”
COVID variant surging in SC see more
When associate professor Julie Hirschhorn, Ph.D., saw the latest results of the Medical University of South Carolina’s sequencing run for COVID variants, she was struck by the absolute dominance of the Delta variant.
“Literally 100%,” the director of MUSC’s Molecular Pathology Lab said. “It kind of boggles my mind. We’re waiting to see what's going to come next. The possibility is that we have hit a branching point where from now on, anything that we see is going to be an offspring of Delta.”
Delta is already a prolific parent variant, spawning a growing number of “sublineages,” or variants with slightly different mutations. Hirschhorn’s colleague, Bailey Glen, Ph.D., is tracking their progress.“They went from there being no Delta sublineages to three to 12. Now we're up to 33, I think,” he said.
“I have never seen that many new lineages pop up quickly,” Hirschhorn said.
What does all of that mean for the public? First of all, the threat to unvaccinated people is clear.“We want them to know that Delta's still very much out there and still very transmissible,” Hirschhorn said.
Second, Glen said, Delta’s mutations serve as a reminder of how important it is to slow the virus’ spread. “The more it spreads the more chance there is for it to mutate, and clearly it can change pretty dramatically and how effectively. We've definitely seen that already. What’s the ceiling on this? How bad can it get? I don't know, but there's no reason to think it can't get worse.”
As for why Delta has been able to vanquish the variant competition so completely, Hirschhorn pointed to its characteristics. “It has mutations in the spike protein that help it get into cells easier. And then some of the other mutations assist in making more copies of the virus itself. So it gets in better and it makes more copies of itself,” she said.
“If you think about virus transmissibility, when we had the original version of the virus, every infected person would infect on average one or two people. And then with the Alpha variant we first saw in the U.K., every person infected would transmit it, on average, to four people. And then with Delta, it transmits on average to seven or eight people.”
Part of the problem may be that Delta causes people to carry higher viral loads, Hirschhorn said. “And so if somebody coughs or you're sitting in a room together and no one's masked, it's going take a shorter period of time to transmit to you.”
The good news is that for now, indications are that the current COVID surge in South Carolina may be easing. In the Charleston Tri-county area, case numbers are still high, but down from the surge’s peak of a couple of weeks ago.
But that doesn’t mean the virus is going away. “One of the things that I do get concerned about when coming off of a curve like this is where we end up, as far as a steady state,” Hirschhorn said, referring to the level where case numbers settle.
“So before Delta hit, we had gotten down to only 1% — it was so low. It's the lowest I'd seen it. My biggest concern is that steady state level of COVID might get stuck at like 5% or 7% or even 10% positivity. And that really doesn't bode well for the next mutated version, because the next wave could result in even higher positivity rates. And if the next variant strain transmits faster, we would start out in a rough spot.”
Her lab is working with the South Carolina Department of Health and Environmental Control to get that message out. “It has been a really positive experience so far. I've had multiple people from DHEC reach out and say, ‘Thank you for sharing your data. This is great. We're so excited.’ I hope that our contribution will help the DHEC website give a clear picture of what's going on,” Hirschhorn said.
She also hopes people use the information to make good decisions. “I guess that's part of this thought process — how do we keep each other safe while still trying to have a life? My best advice is to be kind and think about others. There are ways to get together safely, such as being outside. There are ways to see each other and keep in touch and try to keep that human connection.”
MUSC and Helix launch In Our DNA SC, first-of-its-kind population genomics program to drive preventive, precision health care for South CaroliniansLarge-scale initiative will advance innovative research, improved health outcomes see more
CHARLESTON, S.C. and SAN MATEO, Calif., (Sept. 20, 2021) – The Medical University of South Carolina (MUSC) and Helix have announced a strategic collaboration to develop a first-of-its-kind population genomics initiative in South Carolina called In Our DNA SC. The large-scale program is designed to improve health care outcomes by integrating genetic insights into clinical care and research. The statewide initiative will enroll 100,000 patients in genetic testing over the next four years at no cost to the patient.
The program will enable the use of genomic insights with an initial focus on actionable information regarding a patient’s risk for certain forms of cancer and cardiovascular disease. The genetic reports will allow patients and their health providers to develop precision health care plans to proactively mitigate the conditions and take a more preventive approach to patient care. Patient enrollment in In Our DNA SC is expected to begin in the fall.
In addition, MUSC and Helix will be developing a robust clinico-genomic dataset from consenting participants that will help researchers learn what can cause certain diseases, how we may be able to treat them more effectively and, possibly, improve the standard care for everyone. This is expected to lay the groundwork for a broader collaboration with other organizations across the health care value chain.
“As South Carolina’s only comprehensive academic health sciences center, delivering the highest quality care throughout the state is our top priority,” said David J. Cole, M.D., FACS, MUSC president. “Precision medicine is an emerging field that is going to transform the future delivery of health care. Being a leader and helping to define this path is core to our mission. We are excited to have the opportunity to partner with Helix to deploy this first-of-its-kind population genomic program for our patients. This collaboration will help drive preventive, precision health care for South Carolinians.”
The strategic relationship with Helix allows MUSC to leverage Helix’s unique Sequence Once, Query Often TM model and its end-to-end integration platform to enable immediate application and continual on-demand use of genetic insights throughout a patient’s life. By working with South Carolina’s only integrated academic health sciences center in the state, Helix gains access to thousands of providers and research staff dedicated to understanding how to deliver the highest quality patient care available to serve the people of South Carolina and beyond.
“Large-scale population genomics initiatives like this have the potential to significantly improve a health system’s ability to deliver population and precision health insights to patients,” said James Lu, M.D., Ph.D., CEO and co-founder of Helix. “In similar programs, as many as 1 in 75 participants have been found to be at risk for a serious health issue, of which 90 percent would not have been discovered through traditional practice. By expanding access and making genomic data actionable for health care providers, we will be able to work in tandem with MUSC, the no. 1 hospital in South Carolina, to identify risk earlier and prevent or mitigate serious diseases for its community and beyond.”
Enrollment in the program will initially be available to patients who sign up at select MUSC clinics and locations, later expanding to participants throughout the community and state in collaboration with MUSC’s clinical affiliates and partners. Additionally, participants who consent to securely contribute their genetic data will help MUSC develop one of the largest clinico-genomic datasets in the country. Analyses from this platform will be used to pioneer and further advance genomics research.
About the Medical University of South Carolina
Founded in 1824 in Charleston, MUSC is home to the oldest medical school in the South as well as the state’s only integrated academic health sciences center, with a unique charge to serve the state through education, research and patient care. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy. MUSC brought in more than $271 million in biomedical research funds in fiscal year 2020, continuing to lead the state in obtaining National Institutes of Health funding, with more than $129.9 million. For information on academic programs, visit musc.edu.
As the clinical health system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality and safe patient care while training generations of compassionate, competent health care providers to serve the people of South Carolina and beyond. Close to 25,000 care team members provide care for patients at 14 hospitals with approximately 2,500 beds and 5 additional hospital locations in development, more than 300 telehealth sites and nearly 750 care locations situated in the Lowcountry, Midlands, Pee Dee and Upstate regions of South Carolina. In 2021, for the seventh consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.
MUSC and its affiliates have collective annual budgets of $4.4 billion. The more than 25,000 MUSC team members include world-class faculty, physicians, specialty providers and scientists who deliver groundbreaking education, research, technology and patient care.
Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world’s largest CLIA / CAP next-generation sequencing labs and the first and only FDA authorized whole exome sequencing platform, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employees, governments, and other organizations across the country. Learn more at helix.com.