Milliken leveraging textile expertise in COVID fight see more
Milliken & Company, a global diversified manufacturer with more than 150 years of textile expertise, has invested significant resources to increase domestic production of its Milliken PerimeterTM advanced medical fabrics. Since March, the company has distributed more than 10 million yards of reusable medical fabrics in response to the global shortage of personal protective equipment (PPE). This recent inventory increase signals Milliken’s continued commitment to ensuring a sustainable, U.S.-based PPE supply chain.
Reusable medical textiles are ideal when cost is a driving factor and when single-use PPE supply is limited or unreliable. Garments made with Perimeter fabric can be laundered for safe reuse at least 25 times. The current demand for protective medical garments and the potential for shortages in the fall and winter prompted Milliken to prioritize production of the advanced material.
“Scaling up U.S. manufacturing of reusable protective fabrics protects the country’s PPE pipeline, which in turn protects more medical professionals,” said Chad McAllister, president of Milliken’s Textile Division and EVP, Milliken & Co. “These brave people have continued to care for us tirelessly, and we are committed to doing all we can to help keep them safe.”
Milliken’s durable Perimeter fabric is not only engineered for manufacturing Level 1 and 2 gowns for critical medical environments such as trauma centers but also provides a smart solution for other industries such as dental, educational and hospitality environments where advanced PPE is now important. The material’s ability to be used multiple times while maintaining a demonstrated protective barrier makes it a cost-effective, made-in-USA alternative to single-use PPE.
“An increasing number of industries and service providers are looking for American-made PPE solutions to protect their employees and customers. This demand highlights the critical need we noted earlier this year, specifically for the U.S. to have a stable PPE supply chain,” McAllister said. “Our goal at Milliken is to be part of the solution, so we’re proactively taking steps to help avoid another shortage of critical PPE.”
Milliken is collaborating with industry partners to ensure protective garments made with Milliken Perimeter fabric are available immediately across the country.
SCBIO webinar generates stance from SC Senator Lindsey Graham on repatriation see more
South Carolina's senior Sen. Lindsey Graham introduced legislation last week that he cited as important during a recent SCBIO webinar, saying it will make sure that essential medical personal protective equipment is made in America.
With support from other senators, Sen. Graham introduced the U.S. Made Act of 2020 to “decrease U.S. dependence on countries like China for personal protective equipment for our health care providers."
“With the spread of coronavirus, the inability of the United States to be self-sufficient with our supply of PPE has shown itself to be a national security issue,” he stated. “Just as the United States does not rely on China to supply military uniforms or equipment, we must not rely on them to supply PPE.”
Items declared national priorities include testing swabs, surgical and respirator masks, face shields, surgical and isolation gowns, sanitizing and disinfecting wipes, gauzes and bandages, and privacy curtains, beds and bedding.
The bill also outlines personal protective equipment acquisition requirements for the Strategic National Stockpile, and establishes an investment credit for qualifying personal protective equipment manufacturing projects.
“Coronavirus has been a painful wake-up call that we are too reliant on nations like China for critical medical supplies,” Sen. Graham noted. “Without changes, China remains set to dominate the PPE market for years to come. We have seen firsthand the problems not having a reliable source of PPE places on our health care system. The Chinese grip on this critical supply chain must come to an end, and this legislation accomplishes that goal.”
SC life sciences news of note fro your reading pleasure is now live! see more
This edition of SCBIO's semi-monthly newsletter is chock full of great information, including next week's eagerly anticipated webinar featuring top elected officials on SC's path forward from COVID, the "Slow the Spread" PSA campaign from BCBSSC and SCHA, highlights on companies stepping up in tough times, late-breaking news and more. Read the entire thing by clicking here!
Partnership Reduces Barriers to Testing, Provides Top Quality to Customers see more
Compliments of MidlandsBiz
Partnership Reduces Barriers to Testing, Provides Top Quality to Customers
Nephron Pharmaceuticals Corporation, one of the fastest-growing pharmaceuticals companies in the country, announced a new collaboration with Methapharm.
As a part of this collaboration, Nephron will produce kits of methacholine chloride sterile inhalation solution in ready-to-administer concentrations for bronchoprovocation challenge testing, when diagnosing respiratory illnesses, such as asthma.
“Methapharm will be a fantastic partner,” said Nephron CEO Lou Kennedy. “Patients deserve access to the very best respiratory tests available, that’s what this collaboration will offer, and that’s why we are looking forward to working with Methapharm.”
Working together with Methapharm, Nephron will be able to supply stable room temperature solution kits, ensuring that testing facilities can continue to rely on the quality and reliability of Provocholine for their bronchoprovocation testing needs.
“Through this partnership with Nephron, Methapharm continues its mission to help reduce barriers to testing, provide the level of quality our customers expect, and contribute to better healthcare outcomes for our patients,” said Craig Baxter CEO of Methapharm. “We’ve been impressed by Nephron’s capabilities and professionalism.”
Provocholine® is the only FDA-approved methacholine chloride powder for use in humans. Methapharm, the manufacturer of Provocholine, has always tried to be responsive to needs of our testing partners. For example, in response to the revised ERS technical standard, Methapharm initiated a comprehensive nebulizer characterization study to support the recommendation of PD20 as a clinical endpoint. This was published in a technical bulletin earlier this year.
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.
Vikor Scientific featured in Charleston, Columbia and Greenville Business magazines see more
A number of South Carolina-based life sciences companies joined the battle against COVID-19 when the pandemic hit in early March. Prominent among this group is Charleston-based Vikor Scientific, a testing laboratory founded just over two years ago by entrepreneurs Shae Harrelson and Scotty Branch.
Vikor developed a COVID-19 test kit that is now widely used by nursing homes and other healthcare facilities across the nation. The test kit also tests for more than 40 other pathogens known to cause respiratory illness. Click to enjoy the entire article...
Company opens new manufacturing, quality control facilities see more
AmbioPharm Inc. a leading supplier of peptide active pharmaceutical ingredients has recently opened its new manufacturing and quality control facilities at its headquarters in South Carolina.
“The new buildings were completed in April and qualified by May 15, 2020 expanding our peptide manufacturing capacity,” stated Dr. Chris J. Bai, CEO. “The new buildings add nearly 56,000 sq. ft of production space to our current footprint in South Carolina. In the near future, our subsidiary site in Shanghai will also complete a new campus of 350,000 sq. ft. later this year.”
“As the world battles the Covid-19 pandemic, it has become increasingly apparent that no single solution will suffice for patients who are fighting the disease. Peptide approaches have been recently advanced for potential vaccine development, diagnostic testing and as therapeutic agents to help ameliorate the cytokine storm,” stated Dr. Michael W. Pennington, CSO. “Furthermore, we believe that science will prove to be the Achilles’ heel of the virus, and the world will recover more quickly as better therapies become available,” added Dr. Pennington.
AmbioPharm Inc. is uniquely positioned to help companies that are developing peptide-based approaches targeting the virus. As the company with the world’s largest cGMP peptide manufacturing capacity, AmbioPharm Inc. has a very unique business model which helps us to produce peptides of both high quality and purity with very economical cost. AmbioPharm Inc. can be contacted through our website if you have a project which requires our services.
SCRA funds organizations for their COVID work see more
In response to the COVID-19 pandemic, the South Carolina Research Authority (SCRA) and its investment affiliate, SC Launch, Inc. have dedicated an additional $1.5 million in funding to support businesses that are providing coronavirus-related solutions and to help their current portfolio companies continue to meet their financial goals during this time.
Companies receiving funding to provide COVID-19 solutions are:
- Blue Eye Soft (COVID-19 detection and diagnosis)
- Carolina Diagnostic Solutions (pulmonary self-monitoring tools)
- Citibot (citizen engagement solution)
- Elastrin Therapeutics (treatment of lung-related illnesses)
- Pure Aqua Solution (destruction of pathogens including COVID-19)
- Precision Genetics (COVID-19 testing)
- Resiliency Technology, Inc. dba SHARPEN (mental health support for healthcare workers)
- Zylö Therapeutics (treatment of COVID-19 and other lung related illnesses)
Additional companies have received investments to help them continue growing their companies in spite of the pandemic. These are:
- ActiveEd (Walkabout app promoting learning and physical activity)
- BandwagonFanClub (fan demographic reporting to elevate event experiences)
- Ellipsis Technologies (anti-fraud and other cybersecurity tools)
- Global Transplant Solutions (organ preservation products)
- PEC360 (patient experience software)
- REsimplifi (commercial real estate property search)
“Our mission of fueling South Carolina’s innovation economy includes answering the call to help during this COVID-19 pandemic. Many of our current client companies were already providing or developing solutions related to COVID-19 while others quickly pivoted to address the pandemic. We are proud to be able to provide the support necessary to maximize the impact of these solutions,” said Bob Quinn, Executive Director of SCRA.
In addition to investing financially, SCRA is also involved in other initiatives to help fight the COVID-19 pandemic. Staff members are serving on various taskforces and committees with health systems and economic development organizations. Other SCRA-supported companies are providing solutions to the pandemic including Modjoul, which has developed an employee health screening platform, Humimic Medical and ZVerse, which are producing protective shields, and Vikor Scientific, which is providing respiratory pathogen testing. Lastly, SCRA is sharing COVID-19 resources online and through social media.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation SCRA is a state-chartered organization that fuels job creation and grows South Carolina’s innovation economy. Through SCRA’s programs, SC Academic Innovations, SC Facilities, SC Launch and SC Ventures, researchers, developers and early-stage companies are receiving mentoring and funding, and may be eligible for an investment from SCRA’s investment affiliate, SC Launch, Inc.
ZVerse and Phoenix Specialty Manufacturing step up for South Carolina see more
Two South Carolina companies -- ZVerse and Phoenix Specialty Manufacturing -- jumped into action to meet the needs of the response to the coronavirus, manufacturing vital pieces of equipment at a time when they were urgently needed and unlikely to be easily available for import.
In doing so, they played key roles as the country rushed to provide the medical supplies needed to protect the lives of the sick and their caregivers.
In Columbia, ZVerse began March as a company that helped manufacturers by creating more effective computer files for their production processes. It had the capability to do some 3D printing but did not usually do manufacturing.
SC's Post-COVID Future to be discussed June 23 in free webinar see more
Four leaders from the Palmetto State will be joined by a national expert on Infectious Disease June 23 at 10 a.m. for a free webinar discussion on leadership strategies to help South Carolina weather the challenges of COVID-19 and rebound rapidly from the health, social and economic impacts of the pandemic.
Entitled “Bold Leadership in the Eye of the Storm: Insights & Strategies to Secure Our Future", the program will feature U.S. Senator Lindsey Graham; University of South Carolina President Robert Caslen; Lou Kennedy, CEO of Nephron Pharmaceuticals; and Dr. Phyllis Arthur, VP Infectious Diseases and Diagnostics Policy, BIO. The group discussion will be moderated by Sam Konduros, CEO of SCBIO, the state’s life sciences economic development organization.
The group will discuss such topics as:
- How major universities, colleges and school systems will strive to safely reopen to welcome back students in the Fall, while also encouraging participation in related educational and social activities that are core to the educational experience
- National/global feedback on how the life sciences industry has fared to date in the ongoing battle against COVID-19 and other infectious diseases, and the likelihood and timing for major advances in testing, treatment and vaccines becoming available across the country
- Industry’s perspective on the approach taken to accelerate the reopening of South Carolina’s economy, and what must be done to ensure safety for citizens while battling against the troublesome economic downturn the pandemic has created
- The strategic importance of developing policy around the re-shoring production of essential healthcare equipment, pharmaceuticals and ingredients, personal protective equipment and other medical products and devices back to the US and South Carolina from abroad.
Participation in the webinar is free to all interested parties. Those wishing to participate can register while space remains at https://www.scbio.org/events/lessons-learned-by-industry-government-higher-education-from-the-covid-crisis.
The 60-minute program will provide attendees with a real-time review of the pandemic’s impact in South Carolina to date, implications for returning to normalcy in the upcoming months, and insights and strategies to secure and enhance the state’s future. The panelists will also address a realistic path forward as South Carolina begins the move to return to normalcy while still navigating a virus with no clear endpoint.
“Our goal is to bring the diverse viewpoints of top leaders in government, industry, education and the life sciences industry together in one forum to assess where we are, and how we can make a difference for our citizens in recovering from COVID-19’s impact in the weeks to come,” said SCBIO CEO Sam Konduros.
“The panelists will also share their insights on important lessons learned, strategies for the future, and ways for all South Carolinians to come together to solve health, social and economic challenges and improve quality of life for our citizens,” he added.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 600 firms directly involved and 43,000 professionals employed directly or indirectly in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
For additional information on SCBIO, visit www.SCBIO.org.
COVID testing expands in workplace see more
As industry begins to reopen across the state, life science companies turn their sights to expanding COVID-19 diagnostic and antibody testing options for the workplace.
Greenville-based lab Precision Genetics partnered with Prisma Health in early April to process the health care system’s COVID-19 tests within 24-hours of reaching the lab.
Now that this testing line is fully automated with the capacity to churn out about 1,000 samples in a matter of hours, the lab is developing plans for the next testing battleground with a high-throughput COVID-19 diagnostic program called “Precision Worker Safety” and a smartphone employee wellness app created by Questis that uses an RFID thermometer to report feverish temperatures to employers.
“Up here in Greenville, manufacturing is a huge, huge part of our economic situation, so we have to be able to provide employers some kind of assurance that their employees can come back to work without a rapid spread of the virus,” Nate Wilbourne, CEO and president of Precision Genetics said, adding that it is “naive” to think the state peaked in mid-April with so little testing.
He said Precision is working with several large self-insured manufacturing companies as well as poultry suppliers to develop a salvia-based testing strategy. Pending a state-supported grant that the lab applied for during the week of May 1, Precision will launch saliva-based testing within three weeks.
Other methods of testing face a waiting period before they can be implemented, while the app is several months away from release, he said.
“What we’ve developed is a combination approach to COVID-19 screening and an antibody test as it evolves, as the workforce is building up an immunity at the individual level, which reduces the spread over time,” he said. “Until there’s a vaccine or some type of therapy, that is the safest way to go about this.”
In late April, however, Wilbourne said current antibody tests led to a number of false positives and negatives.
“Unfortunately, antibody testing is not very reliable today, as it sits,” he said. “There are still a lot of gaps in the science regarding the sensitivities and specifications. Right now, there are 50 proteins in the coronavirus. Right now, we (the health science community) are testing for multiple proteins, but there’s no way to guarantee which protein creates immunity.”
He also said antibody testing can only detect antibodies a few weeks after individuals have recovered from COVID-19 but noted that the work of professionals like Dr. John Wrangle, Precision’s chief medical officer and medical oncologist at the Medical University of South Carolina, are heading up research to broaden the window of antibody detection and accuracy of the tests.
Sam Konduros, CEO and president of SCBio, said the life sciences economic development network is working to support continued research and implementation of both diagnostic and antibody testing across the state.
“Even from the beginning, we were trying to present every approved and available COVID-19 test kit option we were aware of, and as you can imagine, we are moving heavily into the world of antibody testing now too,” he said. Our primary goal in representing the life sciences industry in the state is to have a very ecumenical approach of what resources are available that can help employers reopen as safely as possible if working remotely is not an option.”
One way SCBio hopes to open those options to employers is making test kits readily available to state industries through the COVID-19 Emergency Supply Collaborative that SCBio helped develop with the S.C. Manufacturers Extension Partnership, the S.C. Hospital Association and S.C. Department of Commerce.
Created in early April with the goal of bridging shortages in personal protective equipment and other critical needs goods to health care systems, Konduros said the online portal also welcomes purchases from businesses, especially manufacturers, in need of South Carolina-made masks, disinfectant, test kits or a host of other high-demand products.
On April 7, Konduros also noted that antibody testing tended to be a less reliable indicator than diagnostic testing at this point, but he sees potential for companies to use both, especially as antibody testing becomes more sophisticated and “herd immunity” builds.
“From a diagnostic standpoint, there doesn’t seem to be a substitution for PCR testing, which is going to be the one way to confirm a diagnosis for someone with COVID-19, either someone who is showing acute symptoms or has had clear exposure, or is working in an environment where an employer would simply need to know there is that issue,” he said.
On the other hand, Konduros is intrigued by the potential of workforce antibody testing as research moves forward, especially with tests used by Abbott Laboratories, that detect IgG antibodies that remain in the bloodstream for several weeks after an individual recovers from COVID-19. He said that as the state moves into summer, Abbott is planning to release large quantities of IgG tests that are at least 98% accurate.
“I certainly think the antibody tests are going to innovate and improve over time, and there’s going to be a lot more data to see how people are responding who have had COVID-19 and what kind of immunity is being developed. There are just so many variables right now,” Konduros said.
Nephron gets nod from FDA see more
West-Columbia headquartered-Nephron Pharmaceutical Corp.’s fight against the COVID-19 pandemic has received an additional weapon.
The Food and Drug Administration approved the company’s request to add a production line used in the manufacturing of bronchodilator albuterol today, Nephron CEO Lou Kennedy told the Columbia Regional Business Report.
“This news came in 20 minutes ago,” Kennedy said Monday morning. “People are cheering. It’s like The Price is Right or something.”
Kennedy said she expects to hear whether a second production line has been approved later this week.
Last month, Kennedy petitioned the FDA to add up to six production lines moved to Columbia from the company’s previous Florida headquarters in 2019. Kennedy said the additional lines could help the sterile respiratory medication manufacturer keep up with unprecedented demand.
Kennedy said March saw a 141% increase in the doses of inhalation solutions Nephron typically produces a month.
“We went from a regular month of about 80 million shipped to 193 million shipped in March. That’s just for the respiratory side,” she said. “For our sterile injectable medications that we make for all the hospitals in America that have drug shortage needs, that was up by like 22%. We’re seeing the same exact trend in April.”
Kennedy praised the FDA for its quick response, saying the federal agency granted Nephron a CBE-30, “which means Change Being Effected. That’s giving you a goal date of 30 days or less to review your material and be able to say yes or no,” she said.
“That’s really something. You’ve just got to know and feel good as a patient or a potential patient in America that the FDA has been working with me on the phone almost every day, or by email, trying to get this through expeditiously so that we can crank up a few more lines.
“As much as we can make, we’re selling. I don’t want to get behind. So if we can get these other lines approved pretty quickly, then we’ll be able to pump out — if I get four lines, at least another 50 million a month.”
Also helping meet demand, Kennedy said, are the efforts of the S.C. Ports Authority.
Last Thursday, four gigantic containers of automated packaging equipment arrived at Nephron headquarters from Switzerland. Today, the company is expecting air delivery of critical supplies from Italy, one of the countries hardest-hit by the COVID-19 pandemic.
“You know how difficult that was to pull off?” Kennedy said.
Kennedy developed a working relationship with the port as she moved hundreds of millions of dollars in equipment from Florida to West Columbia when Nephron relocated to South Carolina in 2014. During her time as chair of the S.C. Chamber of Commerce from 2018-19, Kennedy came to know S.C. Ports CEO Jim Newsome and COO Barbara Melvin well.
Expecting last week’s shipment of automated equipment to help Nephron workers quickly label, package and ship products, Kennedy called Melvin.
“I reached out to see what the situation was going to be like in getting these pieces of equipment,” she said. “That equipment, which was four giant containers, arrived to the dot at 9 a.m. (Thursday) morning all because of two great South Carolina partners — UPS and its hub that’s located one exit from me, and the Ports Authority.
“All of these drugs that are packaged will go to benefit speedier to-market products for patients with COVID-19. … This is front-line equipment that we need to get our products to market quicker.”
Nephron is also gearing up to begin releasing 100-mL saline bags for administration of sodium chlorine. The minibags, made scarce after the 2017 hurricane season hit manufacturer Baxter Healthcare hard, are once again in short supply, Kennedy said.
“We are very happy to say that we’ve been producing 100-mL saline for the last two weeks in anticipation for this going on shortage,” said Kennedy, who said the bags would be released this past Friday.
While Nephron has ramped up production in response to previous respiratory illnesses such as SARS and H1N1, Kennedy said the COVID-19 crisis is unlike anything she’s ever seen. Nephron began making its own hand sanitizer last month, distributing 50 liters to the William Jennings Bryan Dorn Veteran Affairs Center.
“I had absolutely no idea we’d reach these levels. I couldn’t even imagine, can’t even imagine, still am trying to process,” Kennedy said. “One particular day, two or three weeks ago, one hospital system in New York ordered 3,000 nebulizers from us. A typical thing might be 50, no more than 100. They ordered 3,000.”
S.C. Ports and other transportation partners have helped Nephron fill the exploding demand, Kennedy said, while Nephron workers are proud to be playing a role in combating the virus.
“I couldn’t even begin to compare ourselves with what they’re doing at hospitals, but there is a true sense of patriotism,” she said. “People are coming to work optimistic in the fact that they’re helping, in their own small way, American patients.”
Veravas partners to develop test see more
True Diagnostics, Inc. (TrueDx), a leading Point of Care (POC) company, Infectolab Americas (Infectolab), a recently established CLIA laboratory specializing in comprehensive testing for tick-born infection, and Veravas, Inc. (Veravas), an emerging diagnostic company focusing on proprietary sample preparation products and new diagnostic tests, announced today their Strategic Alliance to develop and commercialize VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test. This novel POC test will utilize the TrueDX Platform™, Infectolab's COVID-19 serology testing services and infectious disease expertise,and Veravas' patent pending VeraPrep™ clean and VeraPrep™ capture technologies to remove cross-reacting antibodies to other coronaviruses while only binding and detecting antibodies specific to SARS-CoV-2. Serology testing makes population screening possible, including screening of people who were never diagnosed, either because they didn't feel particularly sick or they couldn't get an initial test. VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test will play an important roll in understanding COVID-19 and the epidemiology of this coronavirus.
VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test will provide a digital qualitative answer in less than 15 minutes to determine if antibodies against COVID-19 have been detected in the blood. IgM and IgA provide the first line of defense during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgA antibodies tends to indicate a recent exposure to COVID-19 and is more specific for COVID-19 in lung tissues and mucosal surfaces, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients. Current guidance from the U.S. Food and Drug Administration (FDA) recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing, such as with VeraTest™ COVID-19 IgA/IgG Rapid Test, may be considered to further evaluate the possibility of SARS-CoV-2 infection.
"In these challenging times, True Diagnostics, Inc. is proud to be part of this alliance to help expedite critical solutions that can help provide the needed specificity, performance, scalability, and simplicity to market," stated Jerry Lee, CEO and President of True Diagnostics. "Veravas is quickly emerging as the leader in raising the standard of care in laboratory medicine and we look forward to co-developing tools that are essential to support the IVD market and improving the lives of so many patients."
"A collaboration between Infectolab Americas and Veravas is the logical consequence for our two Minnesota companies. We are complementary to each other and have a lot of synergy. We will use this to achieve something that is desperately needed in this time of testing crisis. We will strive to deliver a high quality test for SARS-CoV-2 that is more accurate and sensitive than any other test on the market," said Felix Scholz, President of Infectolab Americas.
"This strategic alliance with TrueDx utilizing their TrueDX Platform™, along with Infectolab's CLIA lab validation capabilities and infectious disease expertise, will allow Veravas to quickly develop a POC test that's easy to use and displays results in under 15 minutes. We are confident that the combined efforts of our three companies will result in the successful development of a rapid test that will assist healthcare providers and laboratorians to quickly and reliably determine whether a patient has developed antibodies to the COVID-19 virus. Most importantly, it will identify those individuals who can safely return to work and go about their daily lives," said Carroll E. Streetman Jr., Chief Executive Officer of Veravas.
TrueDx and Veravas continue to collaborate and expand their portfolios with other emerging organizations and institutions to bring diagnostic solutions and products like VeraTest™ to market.
About True Diagnostics
True Diagnostics (TrueDx) designs and develops innovative POC diagnostic tests and devices based on its proprietary TrueDX™ Platform, which utilizes reliable and low-cost lab methods and its own proprietary or partnered biomarkers to offer rapid diagnoses to facilitate treatment decisions in point-of-care, point-of-incidence and remote-of-care settings. The TrueDX Platform's portability and affordability allow it to be easily adopted into emerging markets to provide accurate diagnosis within minutes. For the $21 billion point-of-care market, the power of the TrueDX Platform lies in its simplicity and flexibility. Tests have an 18-month or longer shelf life with no refrigeration required. The platform's flexible design additionally permits it to quickly commercialize a myriad of biomarkers discovered for cancer, autism, Alzheimer's, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections and more.
About Infectolab Americas
Infectolab Americas is a recently established laboratory located in Oakdale, Minnesota, specializing in comprehensive lab testing for tick-borne infections which provides the tools necessary for Health Care Practitioners to diagnose tick-borne diseases. Their focus is on delivering a quality laboratory performance and guaranteeing a superior sample output; this entails quick shipping time and a rapid turnaround time, as well as providing the most accurate laboratory results possible.
Veravas is transforming laboratory medicine with technology that delivers superior test results, providing confidence to clinicians and patients that diagnoses are accurate. The company's R&D facilities are based in Oakdale, Minnesota, and our staff of scientists and business development are rapidly driving the commercialization of proprietary sample preparation products and new diagnostic tests. Veravas' nanomagnetic particles can identify, remove, and measure select substances from patient samples to reduce the effects of complex interferences and detect low-abundance biomarkers. Led by a passionate and dedicated team, Veravas is devoted to improving patient lives by minimizing the harmful effects of unnecessary treatments and deaths associated with poor quality diagnostic results. Because every patient deserves the correct result, every time. Please visit us at www.veravas.com
Precision Genetics receives SCRA grant see more
SCRA announces a $250,000 SC Launch, Inc. investment in Precision Genetics. The life sciences company, located in Greenville, was recently accepted into SCRA’s entrepreneurial program, SC Launch.
Precision Genetics validated the Emergency Use Authorization (EUA) via the Food and Drug Administration (FDA) to process COVID-19 test kits. Precision Genetics is now available to support state and local healthcare systems in need of public health surveillance, and has priority access to test reagents from commercial reagent manufacturers, which have received EUA from the FDA.
Precision Genetics provides the test kits for healthcare facilities and providers looking to test patients using real-time RT-polymerase chain reaction (RT-PCR) detection of the SARS-CoV-2 virus (the virus that causes COVID-19) in respiratory specimens. The test uses RT-PCR to detect the virus in upper and lower respiratory specimens.
Currently, results will be available within 24 hours (one business day) from time of receipt of the sample in the laboratory, with plans to boost testing capacity in the coming week. Precision Genetics’ healthcare technology laboratory has the capability to direct-connect to other laboratories, healthcare systems, and practitioners’ offices to deliver test information within seconds of the results being reported. The laboratory uses a cloud-based information system, Ovation.io, to help expedite the test orders, specimen tracking, and results to support faster response times to the COVID-19 pandemic.
In addition to COVID-19 testing, Precision Genetics uses an advanced scientific approach to treating employees and patients, using healthcare data to determine the risks associated with medications and complex drug regimens. By combining genetic markers, molecular data, and clinical evidence into a comprehensive and actionable solution, they allow providers to immediately develop individualized treatment and prevention plans for their patients.
“Healthcare facilities throughout South Carolina were struggling to find COVID-19 test facilities that could provide both accurate and timely results”, said Steve Johnson, SCRA Investment Manager. “Some institutions were waiting eight days or more before receiving results. Other testing services were no longer even accepting any further samples. It was critical that an experienced South Carolina-based lab have the throughput capacity to handle the volume of COVID-19 testing that was predicted to be coming. Because of Precision Genetics’ existing track record of providing excellent advanced molecular testing and innovative solutions to healthcare institutions in the state, SCRA and SC Launch, Inc. are proud to provide this investment to Precision Genetics at a time when their capabilities are critically needed in our state.”
“This national and statewide pandemic has challenged us as business leaders to create immediate solutions on behalf of our patients and healthcare providers. The challenge in South Carolina is that we lack sufficient laboratory infrastructure to deploy testing solutions in rapid form in order to manage the immenent demand that our state requires. All labs face a similar obstacle of obtaining the necessary resources and supplies to accommodate our patient volumes. SCRA and SC Launch, Inc. stepped up and provided financial commitment and strategic support for us to expedite our efforts. We are desperately trying to serve our community in this time of need, and we are very grateful for the support from SCRA and SC Launch, Inc.” said Nate Wilbourne, CEO of Precision Genetics.
SCRA is a state-chartered organization that fuels job creation and grows South Carolina’s innovation economy. Through SCRA’s programs, early-stage companies are provided mentoring and grants and may be eligible for an investment from SCRA’s investment affiliate, SC Launch, Inc.
A message from SCBIO's CEO see more
Unprecedented steps are being taken by all of us – businesses and families alike – as we collectively combat the Coronavirus global pandemic that is hitting far too close to home. What was once a news story unfolding in Wuhan, China, only a few months ago has now become a harsh reality right here in the Palmetto State.
As of today, South Carolina has well over 1,000 confirmed cases of COVID-19, and the death rate is starting to climb – and COVID-19 “hotspots” like New York and New Orleans clearly demonstrate how rapidly this situation can deteriorate if we fail to do our parts with regard to social distancing, hand washing, and adhering to the mandate to stay at home as much as possible. The economic hardships accompanying the healthcare impacts of this horrific virus are painfully real and will hit many companies and citizens without mercy. None of us will be untouched, and the toughest days are still ahead…
On a truly encouraging note, collaboration, cooperation, innovation, and goodwill are being displayed by our stakeholders. SCBIO is integrating our efforts and resources closely with numerous fellow associations, agencies and organizations on a simultaneous basis. The SC Department of Commerce, SC Hospital Association, SC Manufacturing Extension Partnership, and the SC Research Authority are only a few of our respected partners that we are working virtually with on a daily basis to do whatever is possible to address vital needs. This potentially catastrophic event is spurring amazing ideas and heroic efforts that will echo for decades to come.
The life sciences and healthcare industries are valiantly front and center as the beacons of hope for conquering this invisible foe. SCBIO is grateful to have a relevant role on the COVID-19 battlefield but is most humbled to see the brilliance and resourcefulness of the companies and organizations we support and represent. There are far too many examples to highlight, but we are so proud of large and small member companies like Nephron Pharmaceuticals, Vikor Scientific, Precision Genetics, Thorne, Abbott Labs, and Humimic that have fearlessly stepped-up, retooled, and refocused to rapidly create desperately needed solutions to arm clinicians and healthcare providers with vital tools they need to effectively carry out their mission to literally save lives – ranging from COVID-19 test kits to respiratory therapies to face shields.
In our role as the Palmetto State’s life sciences industry lead organization, SCBIO has aggressively pivoted our activities to adapt to the demands of the current crisis, making significant decisions to keep our focus where it needs to be – and to demonstrate prioritization of our own work program in a manner that directly relates with the realities that our state and nation are facing. We want and need to hear from you about your efforts – and anything we can do to help.
As meaningful as it is to gather and convene, until some point in the future, nobody needs to be talking about conferences or sponsorships – and the thought of gathering hundreds of people is almost unimaginable at present. Based on that unavoidable truth – and our commitment to be an impactful problem-solver in this crisis – our signature SCBIO Annual Conference has been shifted from its historical time frame of October (2020) to February 16-18, 2021 in Charleston. For SCBIO, it’s a significant and symbolic decision that we felt compelled to make now to demonstrate our conviction to remain focused on COVID-19 issues for as long as is necessary. Likewise, our quarterly board meeting has been rescheduled from April 8th to June 18th at Furman University, with the hope that we might be able to safely convene as we approach early Summer. Until then, all our meetings will be virtual through the blessings of technology.
In closing, SCBIO’s current focus will continue to be:
- Solving supply chain issues by linking life sciences solution providing companies with healthcare providers and clinicians as rapidly as possible
- Working collaboratively with complementary agencies and organizations to solve issues that are challenging our industry, as well as healthcare professionals on the front lines treating patients in need
- Seeking capital and offering support to companies that have novel solutions to combat COVID-19 – but need assistance to scale up
- Conducting weekly webinars on highly relevant topics and COVID-19-related issues to various targeted audiences, ranging from FDA navigation and compliance to small business assistance to leading-edge science-based updates regarding the Coronavirus
- Retrieving and disseminating substantive and data-based/critical information about COVID-19 and making it readily available on our website’s dedicated Coronavirus portal (www.scbio.org)
- Markedly increasing our overall communications by providing two newsletters per month, and launching a short update every week with our new Monday Moment series – featuring crucial updates and member companies that are making a difference, with a little inspiration on the side
- Maintaining a steady series of virtual meetings with companies and organizations across the state and beyond to continue building and advancing life sciences in South Carolina
- Pursuing new grants and funding for high-impact workforce, innovation, and economic development strategies that can directly contribute to our mission
- Honing our infrastructure and skill sets with the goal of becoming the most effective statewide life sciences industry organization in America
- And, finally… Helping whoever we can, whenever we can – as unforeseen opportunities continue to present themselves daily
It is easy for an atmosphere of fear and anxiousness to hang in the air at a time like this, and each of us will experience some of that on certain days in such an alien season of life. But we can’t give into that. We are strong individually, but infinitely stronger together…we need God and each other more than ever, and there truly is a unique opportunity during this to learn, grow, and become better.
Our planet depends on Life Sciences… What a privilege for all of us to be part of that. Let’s fight the battle courageously, together – and seize the opportunity that has been presented.
Wishing all of you health, safety, and peace – Godspeed,
#ONWARD #gamefaceon #TeamSC #SCHelps
Company making up to 71,000 RNA extractions available to testing laboratories see more
GREENVILLE, S.C. – April 1, 2020 – KIYATEC, Inc., a clinical-stage leader in ex vivo 3D cell culture testing that supports cancer drug development and drug therapy decision-making, announced today that it is making high-throughput RNA extraction services available to clinical laboratories nationwide that are conducting COVID-19 testing. By creating additional capacity for RNA extraction, a critical component of the COVID-19 testing process, KIYATEC believes it will help testing laboratories normalize the processing and delivery of test results at a time of unprecedented testing demand and turnaround times.
Most coronavirus tests rely on RNA extraction as the first technical step; without it, the test cannot be performed. Nationwide shortages and backlogs in the reagents and kits most often used to perform these extractions have created bottlenecks and delays that have impacted COVID-19 testing volume and throughput, thereby prompting the U.S. Food and Drug Administration (FDA) to approve alternate testing processes under Emergency Use Authorization (EAU) status. With an already CLIA-certified and operational high complexity lab, KIYATEC is joining the fight against this pandemic by offering its RNA extraction services to COVID-19 testing laboratories.
While KIYATEC’s core business in oncology continues to occupy much of its laboratory testing capacity, the company has elected to make up to 71,000 RNA extractions available over the next two months, effective immediately, on a fee-for-service basis to COVID-19 testing laboratories nationwide. At a time when COVID-19 testing volume and turnaround times are surging, KIYATEC’s 24-hour turnaround time per RNA extraction could provide a cost-effective efficiency boost to laboratories performing these tests. Making RNA extraction services available to COVID-19 testing laboratories is consistent with KIYATEC’s core goals of improving patient care and outcomes.
“Although KIYATEC traditionally serves the oncology community exclusively, we quickly determined that our existing technical infrastructure and capabilities in RNA extraction were ideally aligned to address this critical pressure point in the COVID-19 test process,” said Matthew Gevaert, PhD, CEO of KIYATEC. “Following discussions with public health thought leaders and COVID-19 testing laboratories, we realized that offering RNA extraction services could provide immediate help to these laboratories in overcoming possible supply chain challenges and optimizing their volume and turnaround time potential.”
About KIYATEC, Inc.
KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.
Lillia Holmes, Chief Operating Officer, 864-502-2013