Skip to Main Content

diagnostic testing

  • sam patrick posted an article
    University of South Carolina initiative saving lives see more

    Compliments of The Greenville News

    A gentle hum can be heard from a lab in the depths of the University of South Carolina's life sciences building. Take a peek inside, and you'll find something unusual.

    Thousands of tubes of the spit belonging to the university's students, faculty, staff and Columbia residents.

    Almost a year ago, the school's colon cancer lab changed course from its usual area of study and started analyzing how it could help as COVID-19 ravaged the world, killing hundreds of thousands across the country and shutting down campuses.

    USC professors had a breakthrough when they started studying saliva there, said biomedical sciences professor Phillip Buckhaults.

    They ended up creating what looks like a blue cocktail — and it exposes the COVID-19 genome in our saliva. 

    "We figured out a way to photocopy bits of the COVID genome," Buckhaults said. "It's like a liquid photocopier."

    It's proven to be more efficient than nasal swabs for COVID-19 testing. There's no uncomfortable nasal swab involved. Materials for nasal-swab testing are often limited. And these saliva results come quicker. Those who get tested on USC's campus typically receive results within 24 hours. 

    When the saliva testing first began on campus, scientists were pipetting saliva samples with the "photocopier" liquid to see the COVID-19 genome appeared in the DNA when the saliva was "photocopied" several times.

    Because it was done solely by hand, they were able to test only several dozen samples a day.

    "The demand was more than we could keep up with," Buckhaults said.

    So he sent an email pleading with USC president Harris Pastides for a liquid-handling robot that's able to do the pipetting automatically, saving a lot of time.

    Pastides then got South Carolina-based Nephron Pharmaceuticals owner Lou Kennedy to write Buckhault a $14,000 check to buy one of the robots. 

    "Within two weeks, we went from a junkie, underutilized, decrepit lab space to really state-of-the-art," said laboratory director and professor Carolyn Banister.

    Buckhaults also credited former USC president Bob Caslen for removing roadblocks to get more machines and a bigger lab — speeding up the process to speed up the process, so to speak.

    Caslen worked with the state government and university officials to get thousands of dollars for lab equipment and borrowed testing machines from nearby labs, Buckhaults said. 

    "He saved a lot of lives in the Midlands by pouring resources into (Banister) and that lab and getting this test running," Buckhaults said. 

    Now, the lab is testing about 2,000 samples a day and returning samples within 24 hours, and its reach is beyond the Midlands. Quick-turnaround testing allows people to identify themselves as COVID-19-positive earlier and isolate themselves, reducing the spread of the virus and saving lives. 

    The testing technology has expanded across the state. USC satellite campuses, including Upstate and Union, as well as Clemson, Winthrop, the College of Charleston and Trident Technical College are able to use the saliva tests created at the USC lab.

    The testing is able to recognize different variants of COVID-19 as well.

     September 08, 2021
  • sam patrick posted an article
    Charles River Labs quietly continues its critical work to save lives see more

    Compliments of the Associated Press

    CHARLESTON, S.C. (AP) — It’s one of the stranger, lesser-known aspects of U.S. health care — the striking, milky-blue blood of horseshoe crabs is a critical component of tests to ensure injectable medications such as coronavirus vaccines aren’t contaminated.

    To obtain it, harvesters bring many thousands of the creatures to laboratories to be bled each year, and then return them to the sea — a practice that has drawn criticism from conservationists because some don’t survive the process.

    The blood, which is blue due to its copper content, is coveted for proteins used to create the LAL test, a process used to screen medical products for bacteria. Synthetic alternatives aren’t widely accepted by the health care industry and haven’t been approved federally, leaving the crabs as the only domestic source of this key ingredient.

    Many of these crabs are harvested along the coast of South Carolina, where Gov. Henry McMaster promoted the niche industry as key to the development of a domestic medical supply chain, while also noting that environmental concerns should be explored.

    “We don’t want to have to depend on foreign countries for a lot of reasons, including national security, so it’s good to see this company thriving in the United States,” McMaster told The Associated Press. He spoke this month during a visit to Charles River Laboratories at its Charleston facilities, to which AP was granted rare access. “We want to do everything we can to onshore all of these critical operations.”

    Horseshoe crabs — aquatic arthropods shaped like helmets with long tails — are more akin to scorpions than crabs, and older than dinosaurs. They’ve been scurrying along the brackish floors of coastal waters for hundreds of millions of years. Their eggs are considered a primary fat source for more than a dozen species of migratory shore birds, according to South Carolina’s Department of Natural Resources.

    Their value to avoiding infection emerged after scientists researching their immune response injected bacteria into horseshoe crabs in the 1950s. They ultimately developed the LAL test, and the technique has been used since the 1970s to keep medical materials and supplies free of bacteria.

    Their biomedical use has been on the rise, with 464,482 crabs brought to biomedical facilities in 2018, according to the Atlantic States Marine Fisheries Commission.

    In South Carolina, that’s done only by Charles River, a Massachusetts-based company that tests 55% of the world’s injectables and medical devices — like IV bags, dialysis solutions and even surgical cleaning wipes, according to company officials.

    “We are almost the last line of defense before these drugs leave the manufacturing area and make it to a patient,” senior vice president Foster Jordan told McMaster. “If it touches your blood, it’s been tested by LAL. And, more than likely, it’s been tested by us.”

    Charles River employs local fishermen to harvest the crabs by hand, a process governed by wildlife officials that can only happen during a small annual window, when the creatures come ashore to spawn.

    Contractors bring them to the company’s bleeding facilities, then return them to the waters from which they came. During a year, Jordan said his harvesters can bring in 100,000 to 150,000 horseshoe crabs, and still can’t satisfy the growing demand.

    “We need more, though,” Jordan told McMaster, adding that his company is working with the state to open up more harvesting areas. “The population’s steady. ... We need access to more beaches, to get more crabs.”

    The practice is not without its critics, some of whom have argued that bleeding the crabs and hauling them back and forth is harmful. According to the National Oceanic and Atmospheric Administration, 10% to 15% of harvested crabs die during the process.

    The International Union for Conservation of Nature listed the species overall as “vulnerable,” noting decreasing numbers as of a 2016 assessment. The Atlantic States Marine Fisheries Commission listed 2019 stock as “good” in the Southeast, but “poor” in areas around New York.

    Conservationists sued last year, accusing the U.S. Fish and Wildlife Service of shirking its duty to protect areas including South Carolina’s Cape Romain National Wildlife Refuge by allowing horseshoe crab harvesting. They argued that taking out the crabs affects other species in the protected area. A federal judge temporarily halted the harvest, but was reversed following Charles River’s appeal.

    The environmental groups asked to withdraw their complaint this month after federal officials imposed a permitting process for any commercial activity in the refuge, including horseshoe harvesting, beginning Aug. 15. Even if such permits are denied, Jordan told McMaster that only 20% of its harvest came from the refuge, with most coming from further down the South Carolina coast.

    There is a synthetic alternative to the horseshoe crab blood, but it hasn’t been widely accepted in the U.S., and meanwhile, Charles River’s international competitors are making synthetics and also pressing for U.S. Food and Drug Administration approval, which Jordan said could hamper domestic efforts like his own.

    “My mission is to make sure that any competitor that comes into the United States, from China or any of these other producers, has to go through the same regulatory process that we had to go through, to make sure that it’s safe,” Jordan said. “If all these synthetics start coming in from other countries, we’re going to lose the protection that we’ve had for all these years, and the safety, and the control of the drug supply.”

    “We want to have as much stuff made here as we can,” McMaster said in response.

    As for the environmental concerns, the governor said maintaining a healthy balance between scientific demands and the state’s ecosystems, which bolster a significant portion of South Carolina’s tourism economy, is paramount.

    “It’s like a house of cards. You pull out one part, and the rest of it will fall,” McMaster said. “So I think we have to be very careful, and be sure that any company, any business, any activity, whether it’s commercial or otherwise, meets whatever requirements are there to protect the species — birds, horseshoe crabs, any sort of life.”

  • sam patrick posted an article
    PMLS donates rapid antigen tests to Diabetes Education camps see more

    Premier Medical Laboratory Services donates rapid antigen tests to Diabetes Education and Camping Association Camps

    Many children with diabetes look forward to summer camp each year to, not only spend time with friends, but with other children who can relate to similar day-to-day obstacles that living with diabetes can present. The Diabetes Education and Camping Association (DECA) unites the global diabetes camping community, providing leadership, education, and resources to make camps for those with diabetes more impactful. As most summer camps across the US resumed this year, diabetes camps were faced with the extraordinary obstacle of protecting children who are at higher risk for COVID-19 complications due to diabetes. To bring summer camps for children living with diabetes back this year and to help protect these children, one of the nation’s largest laboratories, Premier Medical Laboratory Services, donated thousands of COVID-19 tests to DECA camps in 19 states across the nation, enabling them to safely return to camp this year.

    “We know DECA and each of their camps do so much for the diabetes community - helping kids to learn how to manage the disease as well as support emotional wellbeing,” said Kevin Murdock, Founder and CEO of PMLS. “With diabetes being a global pandemic, it’s a large focus for Premier Medical Laboratory Services to provide top healthcare solutions for patients with diabetes. We are honored to help camps that improve the lives of children and adolescents with diabetes.”

    For some children, a diabetes camp is their first opportunity to meet a friend who also has diabetes, or their first time staying somewhere without their parents. It’s a great place for them to adopt a new hobby or learn skills that give them more self-confidence. Along with the feeling of independence and support, diabetes camps have been shown to provide children with an increase in diabetes self-care abilities and decreased diabetes-specific distress. (1) For caregivers, diabetes camps provide a medically sound environment where they can feel assured that their children are safe and their diabetes care needs are met.

    Terry Ackley, Executive Director of DECA added: “The safety of children with diabetes is the highest priority of diabetes camps. Covid-19 has presented significant challenges to the operation of diabetes camps this year. It has required that they carefully study their program delivery model and incorporate additional health and safety protocols following the newest guidelines from the Centers for Disease Control. A tool that is very important to safely serving children with diabetes at camp is Covid-19 testing. Premier Medical Laboratory Services approached the diabetes camping community to offer their much-needed support. Our community greatly appreciates their generous donation of a large quantity of rapid antigen tests to diabetes camps across the United States. Premier Medical Laboratory Services has been instrumental to the ability of diabetes camps to operate this year. Their support is helping children learn more about how to manage their diabetes, build resilience to living with this difficult health condition, develop cherished friendships and have lots of fun!”

    Aside from offering COVID-19 testing and many other medical diagnostics solutions, PMLS is continually searching for innovative diabetes prevention and maintenance applications. With some of the most advanced testing panels for both type 1 and type 2 diabetes, PMLS also introduced to the US a first of its kind predictive genetic test for type 2 diabetes, which allows patients to know their risk of future onset of the disease determined by their individual genetic make-up. Along with this, Premier Medical Laboratory Services is currently working with the   Juvenile Diabetes Research Foundation on initiatives to bring soccer clinics to diabetes communities as part of their mission to improve patient lives both medically and through community outreach. PMLS is soon to announce more breakthrough solutions for diabetes care.

    For more information on Premier Medical Laboratory Services, please visit www.premedinc.com or call 866-387-2909.

  • sam patrick posted an article
    Vigilent Labs to distribute COVID-19 test kits and digital health credentials see more

    Enables Vigilent Labs to distribute COVID-19 test kits and digital health credentials to government organizations through GSA schedule

    Vigilent Labs, an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats, has formed a partnership with Seroclinix and Davenport Aviation to distribute COVID-19 test kits and Vigilent Labs v.Pass digital credential technology through Davenport Aviation’s General Services Administration (GSA) Contract.

    “Our government division has worked on adding much-needed medical supplies to our GSA contract to meet our nation’s most pressing needs during the COVID-19 pandemic,” said Rob McMillin, Davenport’s Senior Program Manager. “We are pleased to partner with Vigilent Labs and Seroclinix to provide test kits to government customers through our GSA Contract (#GS-07F-139DA).”

    The COVID-19 Rapid Test kit partnership with SeroClinix’s cost-effective SIENNA Antibody Tests produces fast, reliable and accurate results in seven to 10 minutes, which are CE-marked useful for COVID-19 screening and surveillance under CDC guidance, recently received high marks fro3m the latest International Journal of Infectious Diseases evaluation, and now authorized and approved for purchase through GSA Advantage. A critical advantage of this partnership is the Vigilent Labs “v.LABS” platform and its ability to convert the SIENNA test results into a digital credential that includes one’s COVID-19 Test Results in a v.PASS, facilitating near-real-time health surveillance.

    “Vigilent Labs leverages our existing capability with leading-edge technology to provide a comprehensive solution to the medical community from the Point Of Care environment to the executives and managers responsible for healthcare decision making,” said John Falk, President of Vigilent Labs. “We are proud of this strategic partnership and to provide quality testing and credential solutions to government organizations.”

    This partnership marks an important milestone for Vigilent Labs as an authorized GSA/Government reseller and distributor for COVID-19 Antigen and Antibody test kits in the United States for the United States government.

    “We are excited for our partnership with Vigilent Labs in providing fast and effective test kits for the government,” said Howard Lee, Chief Executive Officer of Seroclinix. “These tests are not only cost-effective but also have the highest reviews made by independent medical evaluations as to the accuracy of the test.”

    To learn more about Vigilent Labs’ solutions for COVID-19 testing and monitoring, visit www.vigilentlabs.com.

     

    About Vigilent Labs

    Vigilent Labs is an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats. The company provides point-of-care (POC) medical testing devices, initially centered on the COVID-19 pandemic, paired with a comprehensive digital health and credentialing platform that offers near real-time tracking of disease. Founded in 2019, Vigilent Labs is headquartered in Charleston, South Carolina, with additional manufacturing and production facilities in Laramie, Wyoming and throughout the United States. For more information, visit www.vigilentlabs.com.

  • sam patrick posted an article
    IMCS growing into new space, adding positions see more

    Compliments of Columbia Regional Business Report

    An Irmo-based biotechnology company is investing $4.1 million to expand its Richland County operations in a move expected to create 31 jobs during the next five years.

    Integrated Micro-Chromatography Systems Inc. creates, manufactures and distributes products and services for clients including clinical and forensic toxicology labs, academic research facilities, federal government agencies and health science companies. In January, the National Institutes of Health awarded the company a $900,000 Small Business Innovation Research Fast-Track grant.

    “Over the past several years, IMCS has experienced considerable success as a part of the Richland County business community,” Andrew Lee, IMCS CEO, said in a news release. “The tax incentives provided by the county will allow us to continue investing in people, capital equipment and facilities to expand our company and increase economic development in the county.”

    Richland County Council approved a special source revenue credit to reduce property taxes for IMCS by 35% over a 10-year period.

    “County Council is always eager to support growing businesses in Richland County, and it is especially exciting to watch a company like IMCS get its start here and achieve so much,” Paul Livingston, county council chair, said. “The investment and new jobs IMCS is bringing to our community will benefit our residents and are evidence of the type of success businesses can achieve here.”

    IMCS’ enzymes are used in drug-testing labs, and drug discovery labs use the company’s micro separations products to discover antibodies that can be used to fight diseases such as COVID-19. IMCS is using the federal grant to scale up production of new enzymes that will be used to make therapeutic drugs for treating neurodegenerative diseases such as Parkinson’s and Alzheimer’s.

    The grant is funding research into the production of affordable gangliosides, biomolecules that contain sugars and a type of lipid called ceramides and play critical roles in various biological processes. 

    In addition to its headquarters in Richland County, IMCS bought a second nearby facility in 2019 and anticipates purchasing a larger building in the county in the future, according to the release from Richland County. IMCS is combining the existing facilities to ramp up production and delivery of its products to pharmaceutical companies worldwide.

    “We were a USC IdeaLabs incubator company and have continued to grow in the county over the past seven years,” Lee said. “As we look to expand our operation to a third facility, it is only natural that we would want to do so here.”

    The new investment and jobs will be split between IMCS’ Irmo headquarters and the new facility. 

    Founded in 2013 by three Ph.D. scientists from the University of South Carolina, IMCS now has 40 full-time employees, with 600 clients in every U.S. state and in 15 countries.

  • sam patrick posted an article
    South Carolina life sciences company adding 148 new jobs to booming industry see more

    Vikor Scientific, LLC, a molecular diagnostics company, today announced plans to expand operations in Charleston County. The $1 million investment will create 148 new jobs.

    Founded in 2018, Vikor Scientific, LLC specializes in antibiotic stewardship and tangible solutions for the practice of value-based medicine in the treatment of infectious disease. The company provides clinicians with advanced molecular methodology for pathogen detection, quantification and resistance gene identification.

    Located at 22 Westedge Street in Charleston, Vikor Scientific, LLC's expansion will increase the company's capacity to assemble and distribute both COVID-19 and full molecular panel testing kits across the country.

    The expansion is expected to be completed by January 2021. Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.

    QUOTES

    "The prior backorder of testing supplies was crippling for the U.S. during the beginning of the pandemic, and no one wants to experience that again. This expansion will help us to continue to stay ahead and increase the production of our testing kits for both COVID and our other infectious disease molecular panels by the hundreds of thousands, which is vital as we enter the sick season." -Vikor Scientific Co-Founder Shea Harrelson

    "Vikor Scientific, LLC's expansion and the 148 new jobs it will create will have a huge impact in Charleston County and across the state. We couldn't be more excited to continue this partnership and watch them succeed here for years to come." -Gov. Henry McMaster

    "Team South Carolina works hard to offer businesses a strong foundation to foster growth and be successful. Vikor Scientific, LLC's decision to expand in Charleston County is an indication that we are doing it right, and we look forward to supporting this great company every step of the way." -Secretary of Commerce Bobby Hitt

    "Charleston County offers an environment supportive of innovation, which is a catalyst for our growth in the life sciences industry. We welcome Vikor Scientific's expansion, as it will have a positive impact on our economy with the creation of 148 new jobs." -Charleston County Council Chairman Elliott Summey

    "As we continue to respond to the effects of the coronavirus pandemic, the remarkable work of companies like Vikor Scientific has proven critical to keeping our citizens healthy and safe. Not only will this expansion create 148 new jobs in Charleston, but it will increase our ability to provide COVID-19 tests to those who need them throughout the state and across the country. On behalf of the citizens of Charleston, I'd like to thank Vikor Scientific for the lifesaving work they do in our community and wish them Godspeed as they continue to expand operations." -Charleston Mayor John J. Tecklenburg

    "Vikor Scientific is a young company making a monumental impact within the life sciences industry, and we are grateful this important work is happening in our backyard. Congratulations to Vikor Scientific on this significant expansion and we look forward to our continued partnership." -Charleston County Economic Development Executive Director Steve Dykes

    FIVE FAST FACTS

    • Vikor Scientific, LLC is expanding operations in Charleston County.
    • The $1 million investment will create 148 new jobs.
    • Vikor Scientific, LLC is a molecular diagnostics company.
    • Located at 22 Westedge Street in Charleston, S.C.
    • Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.

  • sam patrick posted an article
    DPX Technologies introduces new product line see more

    DPX Technologies, a manufacturer of laboratory consumables for sample preparation, announces the development of a new product line for size exclusion chromatography. The technology is patent-pending and utilizes a novel INTip swelling method that supports a hands-off approach for size exclusion chromatography workflows. The automated INTip swelling process allows the gel resin bed to be prepped and ready for sample application in less than 20 minutes.

    Size exclusion chromatography (SEC), also known as gel filtration, is a method by which molecules pass through SEC resin media and are separated by their size. The DPX methodology uses a group separation technique for desalting and buffer exchange where small molecules such as salts are separated from a group of larger molecules such as proteins. Desalting and buffer exchange are commonly used prior to affinity chromatography for antibody purification or polymerase chain reaction (PCR) cleanup. The new product line includes SEC pipette tips and automation accessories, offering a highly reproducible, automated solution for proteomics applications.

    Antibody testing and PCR cleanup are highly conversed topics due to the COVID- 19 pandemic, and DPX is committed to developing products that simplify and automate complex sample preparation for biological matrices. “This new product, along with INTip filtration products for Tip-on-Tip solid phase extraction, will help laboratories that need high throughput methods for processing thousands of samples daily, ” said Dr. Matthew Fitts, lead molecular biologist at DPX Technologies.

    DPX has been manufacturing pipette tips for sample preparation since 2007 and specializes in developing custom workflows for a diverse client base.

    # # #

    About DPX Technologies

    DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.

  • sam patrick posted an article
    Key evidence to be presented at AACR 2020 see more

    KIYATEC, Inc. today announced that it will present data at the 2020 American Association for Cancer Research (AACR) Annual Meeting, June 22-24, revealing how its 3D cell culture models characterize ex vivo tumor response and immunoreactivity to immune checkpoint inhibitors (i.e. PD-1, PD-L1 inhibitors) in solid tumors. These emerging capabilities address a significant unmet need in both preclinical drug development and clinical decision-making in oncology.

    PD-1/L1 inhibitors have experienced meteoric growth over the last decade, offering hope to hundreds of thousands of cancer patients every year in the US alone. However, typically no more than 25-30% of eligible cancer patients who receive PD-1/L1 inhibitors actually respond to them. Given that the direct costs associated with PD-1/L1 therapy can run into the hundreds of thousands of dollars per patient, KIYATEC believes that pre-treatment, patient-specific PD-1/L1 response prediction could one day offer clinicians, patients and payers a more objective basis for determining PD-1/L1 inhibitor patient eligibility vs. today’s commonly used population-based biomarkers. 

    Evidence presented by KIYATEC at AACR 2020 will highlight findings of the company’s ability to detect dose-dependent response to checkpoint blockade and corresponding correlation with immune cell activation in high-throughput ex vivo 3D tumor spheroid models. KIYATEC believes these recent advances may represent key building blocks toward the eventual development and validation of clinical assays capable of accurate pre-treatment, patient-specific prediction of response to immuno-oncology drugs. 

    “We’re constantly innovating and expanding the capabilities of our 3D cell culture technologies to reduce the cost and risk of preclinical drug development for our immuno-oncology customers,” said Matthew Gevaert, CEO of KIYATEC. “As we continue to make these advances in immuno-oncology drug response on higher-throughput platforms, we can begin to envision a time when such capability would inform clinical decision-making for cancer patients as well.”

    KIYATEC’s poster presentations at AACR 2020 are as follows:

    Title: Multifaceted functional assessment of checkpoint inhibitor efficacy using 3D tumor spheroids

    • Abstract: 7397 / Poster: 315 / Session: 3D & Tissue Recombinant Models / June 22-24

     

    Title: PARP inhibition in combination with pembrolizumab enhances cytotoxicity in ovarian cancer patient-derived 3D spheroids

     

    Title: The perfused 3DKUBETM rare tumor assay models in vivo drug response

    • Abstract: 7132 / Poster: 2244 / Session: Immune Checkpoints 2 / June 22-24

     

    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 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. 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. To learn more about KIYATEC, visit www.kiyatec.com.

  • sam patrick posted an article
    Nephron announces new partnership see more

    Nephron Pharmaceuticals Corporation, one of the fastest growing pharmaceutical companies in the country, announced a new partnership with One Medical, a leading national digital health and primary care organization that combines 24/7 access to virtual care and digital health tools with COVID-19 testing services to businesses and employees.

    “Re-opening businesses, and getting our economy moving again, is one of our highest priorities,” said Nephron CEO Lou Kennedy, who is a member of Governor Henry McMaster’s #accelerateSC, the coordinated COVID-19 advisory team tasked with recommending economic revitalization plans for South Carolina. “Part of the new normal for businesses is testing employees to make sure the workplace is safe. We couldn’t be prouder to offer COVID-19 testing services to our employees and neighbors.”

    Kennedy and John Singerling, Chief Network Officer of One Medical and a longstanding healthcare executive based in South Carolina, are working together to make this partnership a reality, hoping that it serves as an example for businesses around the country.

    The Nephron CLIA-Certified lab has procured state-of-the-art technology for COVID-19 real-time PCR testing and serological antibody testing for its own employees, and for employees of neighboring businesses. The lab intends to integrate with One Medical’s technology platform, which is capable of supporting a comprehensive workplace reentry COVID-19 testing program. One Medical’s virtual care solutions facilitate scheduling for specimen collection and digitally documenting those test results. It also screens and evaluates clinical risk factors and symptoms and supports employer tracking and reporting needs.

    “I am very pleased to be working alongside the Nephron team to leverage One Medical’s digital health platform as a way to help get South Carolinians back to work safely,” said One Medical Chief Network Officer, John Singerling. “Currently working with over 7,000 employers nationwide has allowed One Medical to build a comprehensive workplace reentry program that is grounded in medicine and testing, and powered by our technology, which allows for seamless tracking, tracing and ongoing monitoring.”

    SARS-CoV-2 PCR tests diagnose whether a person is infected with the virus by using technology that analyzes viral genetic material. Antibody tests check blood for antibodies. If present, antibodies indicate a person has been previously or is currently infected by the virus.

     

    Nephron Pharmaceuticals Corporation has been on the frontlines of the nationwide COVID-19 response. The West Columbia-based company develops and produces safe, affordable generic inhalation solutions and suspension products that can be used to treat severe respiratory distress symptoms associated with COVID-19. In addition, the company 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. These products are used, many times, to sedate patients and keep them comfortable when health care professionals place them on ventilators in the fight against the virus.

  • sam patrick posted an article
    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.

    About Veravas
    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