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Greenville SC

  • sam patrick posted an article
    Precision Genetics featured in Silicon Review article see more

    Courtesy of Silicon Review

    Silicon Review recently interviewed Nate Wilbourne, founder and CEO of Precision Genetics-- a life sciences organization based in Greenville, SC -- about how the company is making a difference in helping patients use of tools to share genetic risk assessments with their healthcare provider.  Enjoy the complete article here.

     

  • sam patrick posted an article
    Zylo lcoses on $5.2 million Series B round see more

    Zylö Therapeutics has secured funding to advance its Z-pod topical delivery particles, putting together a $5.2 million series B round to support work on a technology with applications in erectile dysfunction and cutaneous lupus.

    South Carolina-based Zylö is built on technology called Z-pods, engineered amorphous silica particles designed to encapsulate compounds. Through encapsulation, the company aims to extend the release of the payload, enable targeted delivery, enhance dissolution and otherwise improve the administration of compounds with a range of physicochemical properties. 

    The potential of the technology has attracted investors including VentureSouth, which contributed more than $1.3 million to the series B, the New York Angels, SC Launch, the Boston Harbor Angels and the Cowtown Angels.

    That mix of new and existing investors came together to pump $5.2 million into Zylö, adding to the $4 million series A round that the company raised in 2019. Zylö issued the series B shares at $0.50, up close to 50% on the series A price. 

    Armed with the money, Zylö will complete internal research projects, further scale up the manufacturing process for Z-pod and fully implement ISO-9001 and cGMP quality systems. The funding also gives the company a financial cushion as it enters a potentially tricky period for VC-backed startups. 

    “The series B funds will extend our runway and hedge against the risk of a recession over the next two years, while simultaneously financing investments that will accelerate growth,” Charles Hinkle, chief financial officer at Zylö, said in a statement. 

    Zylö is applying its technology to erectile dysfunction and cutaneous lupus, an indication in which it has assessed the ability of Z-pods to improve the bioavailability of the endocannabinoid AEA. The company teased upcoming news about “prospective partners that are conducting human studies to demonstrate Zylö’s technology can help combat aging, hyperpigmentation, acne and diabetic foot ulcers.”

  • sam patrick posted an article
    Reshoring accelerates in life sciences, other industries see more

    Compliments of GSA Business Report

    Some South Carolina-based suppliers are feeling a burst of demand as domestic content percentages for materials used in public projects are set to go into effect in October. 

    The Buy American Act – not to be confused with the Reagan-era Buy America Act – was first created in 1933 to give preference to domestic manufacturers. 

    The bill has evolved over the years, but in January 2021, the Biden Administration passed an executive order sparking “the most robust changes to the implementation of the Buy American Act in almost 70 years,” according to a White House news release.

    The order raised the percentage of domestic content required in public projects from today’s 55% to 60% starting Oct. 22, according to a document published by Federal Register. 

    By 2024, the required percentage will climb to 65%, and in 2029, to 75%. The initial increase to 60% will occur several months from publication of the final rule, according to the Defense Department, General Services Administration and National Aeronautics and Space Administration document.

    Andrew McAllister, partner with Washington D.C-based Holland & Knight, shared in a webinar that materials “manufactured in the United States” is not defined in the law, but that it implies a step beyond assembly.

    “Then the second piece of that test is that the cost of the components from the U.S. must exceed a certain threshold of the cost of all components,” McAllister said, adding that iron and steel products undergo more strict standards. 

    Under the new ruling, foreign iron and steel must make up less than 5% of the total cost of components purchased.

    “It doesn’t mean you can never offer a foreign product,” he said. “It’s more so you’re going to be penalized for providing that foreign product.”

    Bringing it all home

    The Buy American Act may often come up in conversations about building materials and construction products, but it also dictates procurement for other forms of federal infrastructure as well – for example, procedure trays used in tax-funded operating rooms.
    COVID-19 wreaked havoc on medical product supply chains Greenville’s CPT Medical depended on for their company’s specimen collection supplies in 2020. 

    “A lot of it was not just made in China, but one of the largest specimen collection manufacturers COPAN is in Italy, and BD is in Germany,” said Austin Shirley, vice president of commercial operations at CBT Medical’s holding company Diversified Medical Healthcare. “So there was very little U.S. production.”

    So, out of necessity, Diversified Medical Healthcare certified its viral transport medium for distribution and launched production. Being one of few domestic manufacturers, Shirley said they couldn’t fill orders fast enough.

    An ongoing shortage of polypropylene wrap used to sterilize surgical instruments later prompted Diversified Medical Healthcare to seek out U.S. partners Hanes Fabrics.

    So, when a federal customer came to CBT Medical with a request for medical supplies and the Buy American Act requirements in hand nine month ago, the OEM supplier was poised for action.

    Now, about 67% of CBT products go toward facilities used by this federal customer, he said. 

    It hasn’t always been easy to find domestic suppliers – especially for plastics, textiles and nitrile rubber components– but Shirley said they’ve uncovered many U.S.-based suppliers able to supply CBT’s custom surgical trays.

    Teasing out impacts 

    Jarrett Martin, president of Mar-Mac Industries, an industrial wire supplier for concrete reinforcement in McBee, said he has witnessed a positive uptick in U.S. suppliers used by the Florida Department of Transportation.

    But, at this time, he said it is hard to pinpoint the booming demand for Mar-Mac products to the Buy American Act alone. More than 90% of his business comes from outside the Palmetto State.

    “It has been difficult to tease out impacts to our business just with all the other noise going on in the supply chain disruptions, and before that, the pandemic, and before that, the steel tariffs from Section 232 by the Trump administration,” Martin told SC Biz News. “We expect a positive impact.”
    Section 232 placed a 25% ad valorem tariff on steel imports from all countries except Canada and Mexico as a national security measure, according to the Executive Office proclamation. 

    Turmoil in the ocean freight market, along with ongoing lockdown in China due to COVID-19, forced many contractors to reassess of their suppliers before the Oct. 22 requirements come into place.

    “Essentially, we saw demand snap back much more quickly than we expected after the spring of 2020, and nobody was ready for it,” Martin said. “Everybody in the supply chain had done the same thing. They had moved to conserve cash and take inventory down, expecting a big recession.”
    The rise in ocean freight prices and the uncertainty of import times has proved kind to Mar-Mac Industries so far.

    “As a domestic manufacturer, I’ve been well positioned to take advantage of that,” Martin said.

  • sam patrick posted an article
    Major PPE manufacturer to invest $150 million, hire 600 in Greenville, SC see more

    A packed house applauded the announcement Monday by Health Supply US, a leading government contracting and medical supply company, to establish manufacturing operations in Greenville County at the Greenville Area Development Corporation’s (GADC) annual meeting at Westin Poinsett Greenville. The company is investing more than $150 million and creating 600 new jobs over the next five years. The new Glove One operation will have the capacity to produce 4.3 billion nitrile gloves annually, with the ability to triple production in the future.

    A dedicated health care industry and government private sector partner, Health Supply US works to secure the United States’ domestic pipeline of medical supplies by identifying, sourcing, and delivering personal protective equipment (PPE) for health care systems and federal, state, and local governments. The company’s FDA-compliant products include Class I medical devices and products such as medical isolation gowns and nitrile gloves.

    The announcement was the latest feather in the life sciences cap of Greenville County and the Palmetto State. Since 2017, life sciences have become the state’s fastest-growing industry and feature a higher growth rate than any other Southeastern state. More than 1,030 life sciences companies are spread across 42 of the state’s 46 counties, employing 87,000 citizens.

    “Health Supply US is dedicated to bringing critical medical supply chains back to the United States,“ said Health Supply US CEO Christopher Garcia. “Nitrile gloves are a vitally needed medical item that keep our frontline health care professionals and first responders safe, an item that we simply cannot rely completely on international markets for our domestic supply in the future.”

    “This major investment by Health Supply US is further proof that our increased efforts to recruit life sciences companies to South Carolina are paying off,” stated SC Governor Henry McMaster at the GADC’s annual meeting. “Expanding our life sciences industry is critical to safeguarding our supply chain and ensuring life-saving medical supplies are readily available during future emergencies. I congratulate Health Supply US on their investment and look forward to the impact they will have statewide.”

    Founded in 2020 during the height of the COVID-19 pandemic with a mission focused on American manufacturing, Health Supply US has employed thousands of American workers across nine facilities in five states. Today, the company operates in the U.S. and Malaysia, and focuses on strategic partnerships for domestic industrial base expansion allowing its operations to scale up quickly to employ thousands of domestic workers producing essential PPE.

    The Health Supply US Greenville County facility will operate as Glove One with a focus on manufacturing American-made nitrile gloves and will employ 600 workers. The state-of-the-art facility will produce more than 4.3 billion nitrile gloves per year and greatly increase the domestic supply for this critical item – helping to protect America’s public health and national security. The Glove One facility will include nearly 400,000 square feet of industrial manufacturing and distribution space and will be located at 1 Quality Way adjacent to Beechtree Business Park.

    “We embarked on this critical project on behalf of our nation, and in doing so, knew that manufacturing site selection was of paramount importance to operational longevity. Greenville and the entire state of South Carolina displayed tremendous enthusiasm for life sciences and support for this medical device operation,” said Health Supply US Executive Vice President Aaron Petrosky. “We’d like to thank all those involved from the Lowcountry to the Midlands to the Upstate that enabled this project to find its Greenville home for many decades to come.”

    The GADC annual meeting was conducted in person for the first time since South Carolina fully emerged from the COVID-19 pandemic. The meeting also featured congratulatory comments by U.S. Senator Lindsey Graham, U.S. Representative William Timmons, GADC CEO Mark Farris and other notables.

    “South Carolina’s life sciences sector continues to grow at a rapid pace – amplified by today’s announcement that Health Supply US is investing over $150 million and creating 600 new jobs in the Greenville County community. Not just a win for South Carolina, Health Supply US’s new Glove One operation is a win for the medical supply chain across all of the U.S. We look forward to a strong partnership with Health Supply US for many years to come,” added Secretary of Commerce Harry M. Lightsey III.

    Health Supply US is committed to transforming the pipeline for America’s health care facilities, first responder networks, and Federal, State and Local Governments by identifying, sourcing, and delivering essential safety and medical supplies to frontline workers and those who need them most.

    The company is dedicated to reshoring PPE manufacturing as a matter of national security so that overreliance on foreign products which led to chronic shortages of critically needed products during the pandemic does not reoccur in the future.

    In addition to the Health Supply US announcement, the GADC celebrated 2021’s strong job creation and capital investment as GADC CEO Mark Farris noted that Greenville County announced capital investment of $1.1 billion and 4,644 new jobs since the start of the pandemic in 2020. For 2021 alone, Greenville County realized $142 million in investment and 1,836 new high-paying jobs, with mean wages well above both County and South Carolina averages.

    The strong numbers were validated by an economic impact study released in 2021 by researchers from the Moore School of Business at the University of South Carolina which estimated that the GADC’s total economic impact in the county exceeds $6 billion annually and sustains 64,784 jobs in Greenville County alone. Over its 20 years of service to Greenville County, cumulative economic impact from GADC activities was validated at more than $55 billion.

    “Despite COVID, Greenville County and GADC have realized a remarkable period of growth by virtually any metric,” said Mr. Farris. “The $1.1 billion in capital investment adds to our community’s economic vitality, diversity, and tax base. And the 4,644 announced jobs, with mean wages well above both County and South Carolina averages, portend a bright future. Raising per capita income is always a primary goal in our efforts, and we continue to raise the bar.”

    “Health Supply US produces and delivers essential safety and medical supplies to frontline workers, our military and those who need them most. Greenville County is excited to welcome the organization as they establish this significant manufacturing facility here, and we wish them long-lasting success," stated Greenville County Council Chair and Greenville Area Development Corporation Board Member Willis Meadows.

    Saluted with the GADC Chairman’s Award at the meeting was Caroline Schroder, Vice President of Business Development & Corporate Services at Coldwell Banker Caine, and a longtime ambassador for economic development in the county. Ms. Schroder’s work has focused on supporting executives and key employees of companies considering relocation and expansion in Greenville County. Knowledgeable in all facets of the county, its schools and assets, her knowledge has provided newcomers information and confidence in choosing Greenville as the home for themselves and their organizations. She was saluted as “a vital and unselfish partner and contributor to the growth and success of Greenville County,” stated GADC Board Chairman Don Erickson.

    Also saluted by GADC Chair Erickson for his contributions was outgoing GADC Director Don Godbey, who welcomed incoming Board members William Moon and Charles Piszczor. Mr. Erickson expressed deep appreciation for the continuing support of GADC Investors, County Council, and leaders from the county’s municipalities.

    About GADC

    The Greenville Area Development Corporation is a non-profit organization established by Greenville County Council to promote and enhance the economic growth and development of Greenville County. Since its founding in 2001, GADC efforts have resulted in the creation of over 30,000 new jobs, nearly $6 billion in capital investment, and a cumulative economic impact of over $55 billion in Greenville County, SC -- including an economic impact of more than $6 billion annually. To learn more, please visit www.goGADC.com or call (864) 235-2008. To learn more about workforce opportunities, visit www.jobsingreenvillesc.com.

  • sam patrick posted an article
    Kiyatec invited to present at prestigious conference see more

    Kiyatec, a leader in functional precision oncology, announced new clinical evidence of its proprietary ex vivo 3D cell culture technology use in high-grade glioma will be presented at ASCO 2022. As a first-time ASCO presenter and exhibitor, Kiyatec will present its Clinical Services and Drug Development Services capabilities at ASCO’s first-ever Innovation Hub at kiosk #IH01. The ASCO meeting will be held in Chicago June 3-7, 2022.

    In this updated cohort of 42 patients with high grade glioma, 3D Predict™ Glioma prospectively predicted patient response to standard of care temozolomide (TMZ), regardless of MGMT methylation status. In a subgroup analysis of the 23 MGMT unmethylated patients, test-predicted responders had a relative median progression-free survival advantage of 5.9 months versus test-predicted non-responders (p = 0.0018). This data provides additional evidence of 3D Predict™ Glioma predictivity and its potential to provide additional information for glioma patient treatment options including clinical trial enrollment, alternative therapies indicated for use in glioma or combination therapy with TMZ.

    Kiyatec Chief Executive Officer Matthew Gevaert, PhD, said, “This enhanced cohort adds to our body of clinical evidence demonstrating the predictive insights 3D Predict™ Glioma can provide to neuro-oncologists planning treatment for glioblastoma patients. With it, we’ve advanced our mission is to disrupt cancer care by accurately predicting patient-specific response and non-response before treatment begins.”

    High grade gliomas, including glioblastoma, are among the most aggressive brain cancers, with patients exhibiting highly variable treatment responses in both newly diagnosed and recurrent disease. TMZ with radiation therapy is the guideline-directed standard of care in the newly-diagnosed setting, which has remained relatively unchanged for over 15 years despite variable patient responses.

    Kiyatec’s ex vivo KIYA-Predict™ pre-clinical platform and 3D Predict™ clinical assays are leading the functional precision oncology space with published, clinically-correlated evidence to prospectively predict glioma patient therapeutic response prior to initiation of therapy.

    Clinical application of a functional 3D ex vivo test to predict therapeutic response in patients with HGG: A progression-free survival analysis
    Central Nervous System Tumors
    Sunday June 5 8:00 – 11:00am
    Abstract ID 2031

    About Kiyatec

    Kiyatec is a functional precision oncology company that measures the response of each patient’s live cancer cells to inform oncologists’ treatment selection decisions. The company’s Clinical Services offers clinical testing for high-grade glioma, and is developing assays for use in ovarian, breast, non-small cell lung cancers, and rare tumors in its CLIA-certified lab. The company’s Drug Development Services works in partnership with leading biopharmaceutical companies to unlock response dynamics for their pre-clinical investigational drug candidates across the majority of solid tumor types. For more information, visit www.kiyatec.com and connect with us on LinkedIn and Twitter.

  • sam patrick posted an article
    Greenville County, SC company makes elite national list see more

    BioPharma companies have been making some huge strides over the last year with innovations driven by both established players and startups entering the scene. With an impressive 7.32% CAGR and a value of $325.17 billion in 2020 it is a huge industry ripe for growth.

    United States is home to a range of established and new BioPharma companies. With a strong foundation & a maturing regulatory space United States offers a wide range of opportunities for BioPharma companies. This list aims to showcase some of the top BioPharma companies and startups in United States focusing on companies with great track records, innovative products or huge future potential.

    Named to the 2022 list of Top Biopharma Start-Ups for the first time is Elastrin Therapeutics of Greenville, South Carolina.  Read the full list here.

  • sam patrick posted an article
    National magazine does cover story on Greenville's Precision Genetics see more

    The February 2022 issue of Healthcare Business Review magazine features Greenville, South Carolina-based Precision Genetics in a fabulous story entitled "Where Precision Healthcare Meets Genetics".  The cover story addresses such topics as the role of genetics in mental health... the pandemic's impact on mental health... a look ahead at the future of healthcare.  Click here to enjoy the complete article.

  • sam patrick posted an article
    SCBIO not playing games with workforce development see more

    Compliments of GSA Business Report

    For those raising the next generation of workforce talent at home, it may be a no-brainer that 12-year-olds are more likely to learn about future career opportunities from TikTok, YouTube or Duolingo than LinkedIn.

    Yet much of the online conversation surrounding new career developments remains resigned to the adult corporate sphere.

    SkillsGapp, a Greenville-based app platform, seeks to broaden that conversation to include the audience making those first steps toward a career.

    The startup offers apps for a variety of fields including skilled trades, aerospace and advanced manufacturing, as well as the fast-growing life science industry. SkillsGapp’s newest app, RadLab, gamifies life science careers for middle schoolers.

    RadLab first bubbled into existence through conversations between SkillsGapp founder and CEO Tina Zwolinski, Upstate SC Alliance and SCBIO.

    “We understand, and the industry understands, that we got to fill that pipeline,” SCBIO CEO James Chappell told SC Biz News, adding that middle school is a key time in the development of interests that later feed into career paths. “So we want to catch them early enough.”

    The free game allows students to try a number of jobs — ranging from the R&D side of the equation to manufacturing to nursing — on for size and level up through a variety of challenges. Teens can test new medicines, obtain Food and Drug Administration approval, manage the manufacturing of products and use them to treat hospital patients.

    Geofencing will link players to the non-virtual world of life sciences during game play through prompts that offer information on local industries and education pathways into the careers they are sampling.

    “They will not only be playing the game and understand what it means to go in these different career paths, but they’ll also have a pop-up that says, if you’re in Columbia, did you know that Nephron is in your area and they have an average of this amount per year, or if they drive by another company, in the Upstate, it’s the same thing,” Chappell said. “They’re getting life science skills without even realizing it, and also learning about these companies and the specific opportunities that there are here.”

    If an educational program, such as a certificate at a local tech school, isn’t available within a certain radius, the mileage limit will expand and alert players to the nearest programs.

    “It’s really helping that player and that student navigate their own interests, which Gen Z does, and then be able to flip the conversation,” Zwolinski said.

    She hopes that students we be more likely to tell their parent or guidance counselor or teacher about careers that spark their interest and how to pursue them instead of the other way around.

    Both in-game and out-of-game incentives help sweeten the pot.

    RadLab, a single-player game, drives up the competition through a leaderboard and badges that teens can earn as they navigate a “skill tree.” There is also an in-game resume that can be used to inform apprenticeship or internship decisions come high school.

    Other competitions could earn students the opportunity to observe a surgery, tour a lab, host a pizza party or win a free semester at a technical college.

    “We’re giving them real-world experiences to connect them out of game, but making them fun, making them exciting to align with the in-game play,” Zwolinski said.

    The game’s strategic planning phase launched in April and is set to conclude later in May. In the meantime, Greenville’s Dr. Phinnize J. Fisher Middle School and the Governor’s School of Science and Mathematics is piloting the program, but Zwolinski expects to form partnerships with institutions and summer camps across the state, especially Allendale County in the Lowcountry.

    A soft launch is scheduled for this summer and a 12-month deployment plan, including a launch poster designed by students at Fisher Middle School, is slated to begin this fall.

  • sam patrick posted an article
    South Carolina delegation a hit at Swiss BIO Day see more

    SCBIO and the State of South Carolina were center stage during Swiss Biotech days in Basel, Switzerland, a conference that hosted 1,000 attendees this week. 

    South Carolina demonstrated its willingness to be on the leading edge and open to partnerships and unique collaborations.  The list of dignitaries that visited with Team SC was impressive, headlined by the President of Switzerland, Ignazio Cassis.  It also included Eva Weigold Schultz, former Charge d’Affaires at the U.S. Embassy in Bern, and global life sciences leaders like AMGEN’s Henrik Asmussen, Dr. Suzanne Grund, of Geistlich Pharma, and many more. 

    I had the opportunity to talk with President Cassis and reinforce our state’s commitment to international investment and collaboration in the life sciences sector, which benefits both countries and, ultimately, translates into better patient outcomes.  As a former physician with a master’s degree in public health, he has a unique perspective on this industry.

    A roundtable discussion with Swiss Biotech Association President Michael Altorfer and other leaders highlighted our current biotech firms with a presence in both South Carolina and Switzerland. Belimed Life Science CFO Simon Engeli and CeQur CFO/EVP Douglas Gunthardt spoke about the positive business climate in the Palmetto State and the tremendous support provided as their companies expanded to the US. 

    With over 30 meetings in two days, and as a featured guest of the conference, our team of SCBIO’s Carla Whitlock, Central SC Alliance’s David King, Charleston County’s Jennifer Brown (also representing CRDA), Sebastian Nowack of the South Carolina Department of Commerce European Office in Munich, Susanna Auf de Maur (a South Carolina native and partner at Kaufmann Ruedi) and with support of the Upstate SC Alliance, successfully laid the groundwork for future investments.  We found an attentive audience as we shared the story of our impressive growth, burgeoning innovation ecosystem, and new infrastructure that is being created to support our industry. 

    We look forward to our return trip next year and to continued collaboration with the Swiss Biotech Association as we learn from each other and support the companies making a difference with innovative technologies and patient outcomes.

    Danke Schweiz...

    Erin Ford
    SCBIO COO

  • sam patrick posted an article
    Greenville, SC organization prepares to move into new 50,000sf facility in Upstate see more

    XtremedX, LLC, a medical device technology and product innovation company based in Greenville, SC has introduced the Temperature and Pressure (TAP) Sensing Insole, the newest addition to its product line.

    The Temperature and Pressure (TAP) Sensing Insole provides early detection of diabetic foot ulcerations (DFU) by incorporating flexible sensors in the shoe insoles of a diabetic patient experiencing peripheral neuropathy.

    Real-time alerts are then sent to the patient, caregiver and physician, providing an earlier warning of issues and potentially preventing an infection that could result in amputation or an extended hospital stay.

    The Temperature and Pressure (TAP) Sensing Insole recently received top honors in the Innovation Challenge at WearRAcon 22, the annual international conference of the Wearable Robotics Association, which was held in Scottsdale, AZ. 

    In addition, the TAP Insole has been chosen as a Top 20 New Device for diabetes treatment by the Diabetes Centre Berne of Berne, Switzerland.  Only two entries from the U.S. were selected for consideration in the competition, with top honors to be bestowed in mid-May.

    XtremedX was selected as a 2021 Top BIOMECHANIC Solution Provider by Med Tech Outlook magazine.  The company, which has two laboratory technology centers in Greenville where it develops products and prototypes, has research relationships with Clemson University, the University of South Carolina, and Duke University.  The organization is preparing to expand into a new 50,000 sq. ft. facility in Greenville to provide room to accelerate manufacture of the insoles and other products.

  • sam patrick posted an article
    Part of a $10 million funding round recently closed by company see more

    Compliments of The Business Narrative

    South Carolina Research Authority (SCRA’s) investment affiliate, SC Launch Inc., has invested in Elastrin Therapeutics Inc.

    The $300,000 investment will help the company advance the development of therapeutics that reverse damaged tissue making it supple again, SCRA officials said.

    The Simpsonville-based biotech startup developed this technology, which restores hardened or damaged arteries and tissues by targeting the elastic fiber and removing the calcification that causes stiffening. Initial applications include reducing hardened arteries, de-calcifying heart valves, and treating diabetes and COPD.

    Elastrin became an SCRA Member Company in 2018 and received a $25,000 Academic Startup Grant. It also received a $50,000 Federal Matching Grant in 2019.

    Elastrin became an SC Launch Inc. Portfolio Company in 2022 when it received this first investment of $300,000. It also received a $50,000 grant during SCRA’s pandemic funding round for startups providing Covid-19 solutions.

    Elastrin recently closed a $10 million funding round, which included this investment.

    It also recently announced the formation of its scientific advisory board, comprised of leading industry and university experts in cardiovascular research and clinical development.

  • sam patrick posted an article
    Premier receives prestigious CAP accreditation see more

    Premier Medical Laboratory Services (PMLS), an advanced medical diagnostic laboratory offering over 2,000 clinical tests, is announcing today their receipt of the College of American Pathologists (CAP) Accreditation. As one of the most stringent of laboratory certifications, CAP Accreditation verifies that the laboratory meets all required standards from CLIA, the FDA, and OSHA. With this certification, PMLS is regarded as one of the world’s top-ranked labs for medical diagnostics which exceeds the industry’s clinical laboratory standards.

    “Quality medical diagnostics are integral for successful patient outcomes,” stated Kevin Murdock, CEO of PMLS. “With that in mind, we are meticulous in our pursuit to deliver accuracy and consistency. That’s why we underwent the CAP Accreditation process - to ensure that we’re an industry leader for the doctors and patients that rely on our testing capabilities. We’re proud of our team that performs at such an extraordinary level and to have achieved this highly regarded certification.”

    In order to receive CAP Accreditation, a laboratory is required to first attain Clinical Laboratory Improvement Amendments (CLIA) certification. CLIA is regulated by the Centers for Medicare & Medicaid Services (CMS), The Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) to set the standards for which a clinical diagnostics lab must operate in the US. Once this certification is attained, a laboratory like PMLS can apply for CAP Accreditation and undergo a rigorous inspection of their laboratory operations to further confirm that precision, accuracy, safety, and best practices are in place. This sets CAP Accredited laboratories apart from most that are in operation today. 

    Along with this achievement, PMLS has reached one of the highest testing capacities in the US, processing up to 100,000 tests per day. They are a trusted testing partner of state health departments, Health and Human Services surge sites, large corporations, professional sports teams, universities, and health systems throughout the country. With an in-house research and development team of PhD scientists, they are continually expanding their diagnostic services. Now, as a CAP Accredited laboratory, doctors and patients can be further assured that PMLS provides the industry’s highest standards for accurate, cutting edge, and reliable diagnostics to improve patient lives. 

    For more information on Premier Medical Laboratory Services, please visit www.premedinc.com.

     

    ABOUT PREMIER MEDICAL LABORATORY SERVICES

    Premier Medical Laboratory Services® is fully certified by all major accrediting organizations including Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) Accreditation. Utilizing the latest equipment, including liquid chromatography mass spectrometry (LCMS), molecular, Next Generation Sequencing (NGS) and other technology, we provide high analytical standards and accurate interpretations along with unsurpassed turnaround times for clinics and physicians.  As an industry leader in molecular diagnostics, our in-house team of PhD scientists, laboratory staff, and customer care team deliver accuracy and reliability that is unmatched. We are innovators and thought leaders, moving the medical industry forward with the latest in science and technology. As a top of the line, highly complex diagnostics lab, we are committed to help our clients meet the highest standards in patient care and specialize in the following areas:

    • General and Routine Chemistry's

    • Advanced Cardiovascular Testing

    • Allergen – Specific IgE Blood Testing

    • Women’s Health

    • Pharmacogenomics

    • Patient Rx Monitoring

    • Molecular

    • Wellness Panel

    • Covid-19 Testing

  • sam patrick posted an article
    KIYATEC expands team by adding two executives see more

    KIYATEC, the leader in clinically correlated, published functional precision oncology technology today announced two key appointments as the Company builds utilization of clinical 3D Predict™ assays and grows its pharmaceutical services portfolio for KIYA-PREDICT™. KIYATEC is pleased to welcome Bruce Yeager as Vice President Market Access & Reimbursement effective March 21, 2022, and Steven Holshouser, Ph.D., as Director, Business Development, effective March 8, 2022.

    Chief Executive Officer Matt Gevaert, Ph.D., said, “We are pleased to welcome both Bruce and Steven to our growing team of experienced leaders in their respective fields. Bruce’s significant experience and effectiveness in securing and expanding Medicare and private payer reimbursement and coverage will support the commercialization of 3D Predict™ Glioma and Ovarian assays in 2022 and lays the foundation for reimbursement and coverage plans for our non-small cell lung, rare tumor, and breast cancer assays in the future. Steven’s track record in securing pharmaceutical services contracts will expand revenues from our growing portfolio of clients using KIYA-PREDICT™ therapeutic response and 3D cell culture technology applications in their drug development plans.”

    KIYATEC’s clinical and pre-clinical technology platforms, 3D PredictTM and KIYA-PREDICTTM, respectively, are leading the functional precision oncology space with published evidence of predictive response correlated to clinical outcomes. Recently the Company represented its 3D Predict™ Ovarian publications at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer and announced six abstract acceptances to be presented at the American Association for Cancer Research from April 8-13, 2022 in New Orleans.

    About KIYATEC

    KIYATEC is a functional precision oncology company that measures the response of individual patient live cancer cells with its innovative 3D cell culture technology platform. The Company offers clinical tests for high-grade glioma and is developing tests for ovarian, breast, non-small cell lung and rare tumors in its CLIA-certified lab. The Company works with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types. For more information, visit www.KIYATEC.com and connect with us on LinkedIn and Twitter.

  • sam patrick posted an article
    Finding ways to build the workforce of tomorrow demands new approaches see more

    Finding skilled workers to fill jobs in the life sciences sector is now harder than ever, but some locations are doing it better than most thanks to innovative thinking and creative programs like those exhibited in South Carolina, with Luxor Scientific and Greenville County, SC featured in this article.  Enjoy Ron Starner's article in this latest issue issue of Workforce 2022Click to read article.

  • sam patrick posted an article
    Bravery, generosity mark efforts to beat rare disease see more

    When Cortney Gensemer visited her professor during office hours to discuss her Ph.D. dissertation, she had no idea she would be able to study her own disease. 

    Gensemer, a doctoral candidate at the Medical University of South Carolina, first started noticing her symptoms at age 14, when she was forced to sit out the first year of girls varsity lacrosse at her high school in Pennsylvania. She endured numerous joint dislocations and soft tissue tears in both hips before she was diagnosed with hypermobile Ehlers-Danlos syndrome, a rare genetic connective tissue disorder that affects joint and neck movement, at age 19. 

    Prior to her diagnosis and over a year into Division II college lacrosse at West Chester University, she thought her constant injuries meant she just wasn’t as tough as the other athletes on the field. 

    “None of the physical therapists or athletic trainers I was seeing were familiar with EDS,” Gensemer said. ”There was no one saying, ‘This is something bigger.’ ” 

    Now, at age 25, she’s in the last year of her doctoral program at MUSC and recovering from her eighth surgery since being diagnosed. 

    Aside from the gray and blue brace she wore after her most recent surgery to keep the joints in her neck in place, she appeared in good health while working with school lab partners at the end of February. 

    A tattoo of the word “resilience” on her left forearm serves as a reminder to push through moments of severe pain. She calls it her EDS tattoo.

    “It pushes me to want to work hard because I’m literally living with what I’m researching,” Gensemer said. “I’m going to be in awful chronic pain whether I’m sitting on the couch or in the lab.”

    Now, MUSC is on the brink of opening the country’s first Ehlers-Danlos syndrome institute for research, clinical care and education on the disease.

    Symptoms of the hereditary disease range from frequent joint dislocations, joints that extend beyond the normal range, and loose ligaments in the neck and spine. 

    EDS affects roughly 1 in 3,000 people worldwide and so far has 14 different variations. The hypermobile variant is known to be the most common. However, researchers say the real number could include many more since the disease is often undiagnosed or misdiagnosed. Currently there is no cure for EDS. 

    Gensemer is one of the only reasons EDS is being studied at MUSC. Her studies are housed in the Norris Lab, where her professor, Dr. Russell Norris, leads her and a team of 13 researchers and volunteers, some of whom also have EDS. 

    She and the team have so far identified the first strong candidate gene for hypermobile EDS, which could lead to new ways to diagnose patients earlier and more definitively.

    “I didn’t realize how powerful my own story could be,” Gensemer said. “An EDS Institute is something that patients like me have dreamed about our entire lives.”

    Living with EDS
    It can be years before a patient actually confirms they have EDS. And different variants of the disease show up with different symptoms.

    Gensemer was diagnosed within the first five years of exhibiting symptoms, while the average EDS patient waits 10 to 14 years to be properly diagnosed.

    “Hypermobile EDS is really difficult to diagnose because there isn’t a molecular or genetic diagnostic test for it,” Gensemer said. “Identifying this new gene is going to ensure patients aren’t passed around from doctor to doctor or living with vague symptoms for years without knowing what connects them.”

    For most EDS patients, undergoing numerous surgical procedures to reduce chronic pain is a necessity and often the best option for long-lasting relief. 

    Gensemer’s most recent surgery addressed loose ligaments in her neck that couldn’t hold her spine in place. Some doctors say this movement between the neck and head resembles the movement of a bobblehead, causing severe neck pain, sensitivity to light and lingering headaches. 

    To help, doctors fused the vertebrae of her spine together with titanium plates and screws to properly support her head, relieve lingering pain and prevent further symptoms. 

    Gensemer said that before she could undergo surgery, doctors needed to perform an upright MRI to determine what parts of her neck and spine needed support.

    This specific MRI helps to diagnose certain spinal and neck complications of EDS that don’t show up on an MRI scan in the traditional position. 

    However, the nearest upright machine is in Greenville, a nearly four-hour drive. A ride that length can be incredibly painful and in some cases near impossible for people with EDS. 

    That was the case for Sydney Severance, a 16-year-old from Daniel Island, who was diagnosed with EDS in 2020 after months of shuffling back and forth to doctor appointments. 

    Severance’s symptoms left her wheelchair bound, constantly vomiting and extremely sensitive to light. At MUSC, neurological and spinal specialist Dr. Sunil Patel suggested she may be suffering from craniocervical instability, a type of loose ligament condition in EDS that results in injury to the nervous system.

    Finally, she had found a physician who could tell her what was causing her so much pain. But in order to officially diagnose Severance she would need to have an upright MRI scan done, and she wasn’t able to make the drive. Luckily, a family friend of the Severance’s flew them to Greenville privately for the MRI, where her diagnosis was confirmed.

    “It was still excruciating and very difficult to be moved around and have a long day of travel, even though my situation was a lot better than some patients,” Severance said. 

    While Severance agrees that luck was on her side, many others like her who have to drive may turn a four-hour drive into a multiple day trip.

    She recalled talking with an EDS patient who suffered from seizures due to the same loose ligament problem as Severance. The other patient had at least 18 seizures during the trip for their MRI scan. 

    To Severance, the path to diagnosis for patients with this disease is much longer than the drive to Greenville. In fact, some patients go so long without knowing their affliction that it causes severe psychological trauma and confusion regarding the pain they are experiencing.

    So after undergoing her first successful surgery for EDS in 2020, Severance founded Operation Upright, a campaign to raise over $1 million to bring an upright MRI machine to Charleston. 

    Her campaign aims to lessen the average time for diagnosis and give other EDS patients like her a chance at early detection. So far it’s raised over $800,000 out of the $1.2 million goal, including a recent anonymous donation of $600,000. 

    “I was able to get a diagnosis much faster than most people,” Severance said. “I think having an upright MRI machine in Charleston would help a lot of other people reach diagnosis quickly.”

    Gensemer’s research and Severance’s fundraising position them as two of the strongest forces advocating for EDS in the state, fighting for more information and better treatment options for patients across the country and especially within the Lowcountry. 

    Gensemer also developed an EDS patient registry, collecting DNA information from over 3,000 patients nationwide for further genetic research. So far, nearly 80 percent of patients in the registry inherited the disease from a family member.

    According to Norris, the MUSC professor who leads the lab Gensemer works in, the gene they discovered could help doctors decide on the best treatments and physical therapies for patients, and possibly reduce the amount of surgeries a patient undergoes in a lifetime. 

    Now they are testing the theory with animals, transferring the identified gene in humans to mice in their lab in hopes of being able to expand their studies on the disease.  

    “The mice are hypermobile and have changes in connective tissue,” Gensemer said as she carefully held one of the lab mice by the tail. “Now we can use that mouse to expand our studies.”

    While both Gensemer and Severance are currently recovering from surgeries due to complications with EDS, they both say the work they are doing motivates them to keep going. 

    “Fundraising for this upright MRI really keeps me positive because I’m able to turn what has made my life a lot more difficult into something a little more positive,” Severance said. 

    So far, complications from EDS have resulted in Severance relearning to walk at least twice since being diagnosed, and her most recent surgery left her in the hospital for 16 days. 

    “She’s incredibly positive,” said her mother, Ashley Severance. “Even as she was learning how to walk again, she considered herself lucky.”