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.
Senator views progress one year later see more
Senator Tim Scott’s senior staff visited Diversified Medical Healthcare (DMH) headquarters, touring the Greenville, SC facility which houses four healthcare companies making a national impact. Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical serve as a large-scale molecular diagnostics lab, clinical test kit manufacturer, surgical kit manufacturer, medical data management software firm, laboratory equipment supplier, and PPE kit supplier.
Just one year ago, Diversified Medical Healthcare’s laboratory, PMLS, became the first lab validated for COVID-19 testing in South Carolina alongside their other advanced clinical diagnostics offerings. Providing an inside look at their 40,000 sqft faciltiy for the US Senator’s staff, DMH founder, Kevin Murdock introduced them to the company’s research and development team of Ph.D. scientists and over 450 employees as well as showcased the cutting edge laboratory automation equipment which has allowed them one of the highest laboratory testing capacities in the nation.
“From leading research and innovation to generously donating PPE for our front line workers, Diversified Medical Healthcare has been a valuable partner for South Carolina as we’ve worked to get through the pandemic,” said Senator Scott. “Their efforts highlight the life-saving impact of American innovation, and I am proud of the work they have done.”
The senator’s staff toured the laboratory where over 1,000,000 COVID-19 tests were processed during the last year and data has been managed by their laboratory information management software developed in-house. They viewed CPT Medical where over 6,000,000 COVID-19 testing kits and viral transport media have been manufactured and saw the Vessel Medical facility where hundreds of thousands of customized PPE supply kits were assembled and distributed.
In the laboratory, PhD Scientist, Vidhya Narayanan spoke with them about a large scale genomic sequencing that Premier Medical Laboratory Services is conducting for the surveillance of new variants of the Sars CoV-2 virus. As the only laboratory in the US fully automated for Next Generation Sequencing, PMLS expects to sequence up to 84,000 specimens per week. This will be a critical contribution in preventing a future surge of new COVID-19 variants.
“It was a high honor to have Senator Tim Scott’s team here and to show them all that we’re doing right here in South Carolina to improve healthcare across the US,” said Kevin Murdock, founder of Diversified Medical Healthcare. “Senator Tim Scott has done much to improve healthcare and create jobs, and those are two of the driving forces behind what we do here as well.”
The visit of Senator Tim Scott’s staff, comes just two weeks after SC State Representatives, Bobby Cox and Bruce Bannister visited the facility to view all that DMH is doing to contribute to healthcare in the state of South Carolina and the nation.
Over the past year, Diversified Medical Healthcare companies have also:
- Reached one of the highest testing capacities in the nation with the capability to process over 300,000 tests per day
- Developed medical data management software that communicates directly from laboratory equipment for faster delivery of data to healthcare providers and patients
- Developed Virtual Lab, an innovative solution to laboratory infrastructure limitations which allows other labs to utilize PMLS’ testing capacity, 450 employees including a research and development team of PhD scientists, and top of the line lab equipment
- Developed Lab in a Box, turnkey lab equipment for other labs, hospital systems, and large organizations that comes with everything needed for professional laboratory level diagnostics for COVID-19, Flu A and B, upper respiratory, STD/UTI, cancer risk screening, pharmacogenomics, and antibiotic resistance testing
- Shifted production to add in-house manufacturing of COVID-19 testing kits
- Achieved the capacity to produce 60,000 COVID-19 testing kits per day
- Become the official COVID-19 testing lab for the United Soccer League (USL) and Division I/Division II teams in 7 collegiate conferences as well as large schools and business organizations across the US
- Become the processing lab for Human Health Services surge sites and state health departments in South Carolina, Arizona, Utah, and North Carolina
- Become the Blue Cross Blue Shield preferred COVID-19 testing lab in Texas, South Carolina, and North Carolina
- Donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic
For more information, please visit www.divmedinc.com or call 866-521-7541.
ABOUT DIVERSIFIED MEDICAL HEALTHCARE
Diversified Medical Healthcare (DMH), a holding company with four subsidiary healthcare companies, Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical. PMLS is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including Clinical Laboratory Improvement Amendments (CLIA) and COLA. PMLS testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women’s Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DiabetestPredict. CPT Medical, Inc. has manufactured surgical custom and standard procedure trays, packs, and kits assembled to fit specific needs and requirements for over 15 years. Now, CPT Medical also manufactures and distributes COVID-19 testing kits with the FDA recommended viral transport medium as well as nuclease free water for laboratories. OnGen is an advanced Laboratory Information System that automates laboratory processes for higher efficiency, accuracy, and profitability. Vessel Medical, since its inception in 1991, has been committed to providing physician’s offices, hospitals, laboratories and their employees with the right workflow solutions, medical supplies, and medical equipment for their needs. Included in their medical equipment offerings is ‘Lab in a Box,’ turnkey laboratory equipment that can turn a 600 sq. ft. room into a COVID-19 testing facility with the capacity to process up to 12,000 tests per day within 24 hours. For more information, please visit www.divmedinc.com or call 866-521-7541.
DPX earns SBIR grant see more
DPX Technologies, a manufacturer of laboratory consumables for sample preparation, receives over $250,000 from the National Science Foundation (NSF) for a Small Business Innovation Research (SBIR) Phase I project. The project involves rapid purification of RNA and the development of fast detection for COVID-19.
RNA extraction is a key pre-analytical sample preparation step for viral RNA detection. Viral RNA detection is the current worldwide strategy used for early detection of the novel coronavirus SARS-Cov-2. The magnitude of the COVID-19 pandemic calls for unprecedented high throughput testing.
DPX Technologies has been developing sample preparation products for high throughput, automated methods for over a decade. Their patented and proprietary pipette tip technology harnesses the power of automated liquid handlers to provide solutions for a variety of applications. DPX was able to leverage the help and expertise of Tyler Tatum at 3Phase SC. “Tyler helped with navigating through all of the paperwork and rules. He was great to work with and extremely knowledgeable,” said William Brewer, CEO of DPX Technologies and principal investigator on the SBIR Award.
The South Carolina Department of Commerce Office of Innovation launched 3Phase in 2018 as a resource aimed at assisting research-based companies in South Carolina successfully acquire Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards. 3Phase provides training and workshops throughout the state on the federal SBIR and STTR programs, while managing the application process for a portfolio of companies, both at no cost to participants. The SBIR program funds early-stage research and development and is designed to provide equity-free funding. These investments stimulate technological innovation in the private sector, strengthening the role of small business in meeting federal research and development needs.*
* Excerpt regarding information on 3Phase program from South Carolina Department of Commerce website and https://www.3phasesc.com/
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.
Diversified Medical Healthcare Celebrates One Year Since FGDA Validation of State's First COVID-19 Testing LabCompany has processed over one million COVID tests see more
Diversified Medical Healthcare (DMH), a holding company with four subsidiary healthcare companies, Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical, has provided leading-edge solutions to combat COVID-19 nationally, addressing supply chain gaps and infrastructure restrictions caused by the virus. Their molecular diagnostics laboratory, PMLS, became the first lab in South Carolina validated as an independent COVID-19 testing lab one year ago. Just as PMLS achieved this validation for testing shortly after the first case was reported in the US, they continue to meet demands caused by COVID-19 as they arise with their laboratory staff of over 360 employees and in-house research and development team of Ph.D. scientists. Along with large scale testing via state of the art automated lab equipment, DMH companies developed advanced software for most efficient data management, distributed customized PPE supply kits, and manufactured COVID-19 testing kits as well as viral transport medium that properly preserves specimens during transit.
“Since COVID-19 became a threat to our nation, we quickly streamlined our workflow, hired employees, validated various coronavirus assays, and purchased the equipment needed to test a large volume of specimens with the highest quality standards,” said Kevin Murdock founder of Diversified Medical Healthcare. “With our laboratory having one of the highest testing capacities in the nation, an in-house medical manufacturing firm, a lab equipment company, and data management software company, we feel that it’s imperative to do our part to help keep the country open and our citizens safe.”
At this one year mark, PMLS has processed over one million (1,000,000) tests to determine COVID-19 results for patients nationwide. With their highly advanced laboratory information management system (LIMS) created by OnGen, data is communicated directly from high throughput laboratory equipment for fast, accurate storage and delivery of data to healthcare providers and patients. Many of PMLS’ lab processes are automated to allow them a testing capacity of 300,000 tests per day. With this scalability, PMLS has enabled other laboratories and testing sites to increase their testing capacity and turnaround of results with Virtual Lab. An innovative COVID-19 testing solution to overcome laboratory infrastructure restrictions, Virtual Lab allows these facilities to utilize PMLS’ fully-automated robotic workflow and team of 360 employees to largely increase their testing capacity and efficiency while bypassing the need to purchase new equipment or endure waiting time of weeks or more for shipping, installation, and validation. Along with helping other labs, hospital systems and large organizations to test more patients, Diversified Medical Healthcare has donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic.
As another means to aid laboratories, healthcare systems, and large organizations in the expansion of their COVID-19 testing, Vessel Medical offers Lab in a Box, turnkey lab equipment that comes with everything needed for professional laboratory level diagnostics for COVID-19, Flu A and B, upper respiratory, STD/UTI, cancer risk screening, pharmacogenomics, and antibiotic resistance testing. Developed by leading scientists and technicians in partnership with Hamilton Company, Thermo Fisher, and Grenova, Lab in a Box enables a high capacity of onsite diagnostics for hospitals, expanding laboratories, schools, and large companies in need of quick and accurate testing results. With precision robotic instruments, lab in a box includes high throughput liquid handling along with automated, custom-programmable pipetting that decreases human error and result turnaround time.
Another DMH company, CPT Medical, shifted their production of surgical supplies to include manufacturing of COVID-19 testing kits since the beginning of the pandemic. CPT Medical is now capable of manufacturing 60,000 test kits per day and works in conjunction with PMLS to offer customizable testing to large organizations. Some of the large organizations that PMLS has partnered with as the official COVID-19 testing lab are the United Soccer League (USL) and Division I/Division II teams in 7 collegiate conferences as well as large schools and business organizations across the US. PMLS is also the processing lab for Human Health Services surge sites and state health departments in South Carolina, Arizona, Utah, and North Carolina and is the Blue Cross Blue Shield preferred COVID-19 testing lab in Texas, South Carolina, and North Carolina. Through all of these partnerships, PMLS has continued in their reputation of delivering the most advanced testing with rapid, reliable results, and diligent customer care.
Now, as vaccines are administered and restrictions on social distancing are being lifted, PMLS is conducting a critical large scale genomic sequencing for the surveillance of new COVID-19 variants, taking proactive measures so that a future surge of a mutated Sars CoV-2 strain is less likely to occur. The data collected from genomic sequencing can help pharmaceutical companies to stay ahead of the variants and make any changes needed to the current vaccines and treatments for higher efficacy and best patient outcomes. With PMLS’ high throughput genomic sequencers and library prep instruments that automate the library prep and sequencing process, a much higher capacity for genomic sequencing is achieved and margins of human error are drastically reduced. By sequencing an exponentially higher amount of specimens, PMLS is better equipped to provide meaningful analysis with larger amounts of data and faster turnaround times for the effective surveillance of SARS-CoV-2. PMLS is in discussions with the CDC and multiple states across the nation to provide COVID sequencing services at ports of entry and local and regional hotspots. Along with this and their previous accomplishments, more groundbreaking COVID-19 solutions by Diversified Medical Healthcare are soon to be announced.
For more information, please visit www.divmedinc.com or call 866-521-7541.
Producing and shipping 10,000 Rapid COVID-19 antigen test kits for King of Hammers racing event see more
Vigilent Labs, an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats, has completed and shipped its first major order of Alfa Scientific Instant-View COVID-19 Antigen Test Kits for use in the King of Hammers racing event.
”We have worked diligently for months to progressively and proactively execute the safest off-road racing event possible, and we could not have held this event without the help of Vigilent Labs,” said Dave Cole, Lead for the King of Hammers Race and President of Hammerking Productions. "Our innovative partnership with Vigilent Labs enabled us to navigate public health requirements and deploy a comprehensive digital COVID monitoring solution for pre-screening our racing event attendees to ensure their health and safety."
This project marks an important milestone for Vigilent Labs and the South Carolina life science sector as the company recently announced that it is investing more than $104.6 million and will create over 400 new jobs at its state-of-the-art COVID-19 test manufacturing facility in the Charleston Navy Yard.
"Our Vigilent Labs Medical Systems technology platform is the first digital health credential connecting a real person to a rapid COVID test, taking health surveillance to the Next Level,” said John Falk, President of Vigilent Labs. “With the outstanding support from the entire FedEx organization, we were able to quickly get these important COVID-19 test kits into the hands of the King of Hammers organizers, enabling their public event to go forward in California."
The cost-effective rapid antigen tests, which produce fast and accurate results in seven to 10 minutes, are CE-marked and pursuant to CDC guidance, useful for COVID-19 screening and surveillance. The kits will be immediately put to use by the King of Hammers Racing event, which is being held from January 28 to February 6, 2021, in San Bernardino County, California, to pre-screen attendees for COVID-19. This event is the first widely attended event to deploy the Vigilent Labs’ v.PASS digital credential, the company’s state-of-the-art health monitoring solution, to ensure adherence to increased federal, state and local safety guidelines.
“We take pride in our dependable, fast and efficient transportation mechanisms, which enabled us to help Vigilent Labs to deliver these COVID-19 antigen tests,” said Elizabeth Tonelis, FedEx Sales Executive.
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 https://vigilentlabs.com/.
Nephron, Lexington County businesses step up again see more
WEST COLUMBIA — Nephron Pharmaceuticals CEO Lou Kennedy watched proudly from her office window as a company security guard rushed out to help a woman with a hot pink walker from her vehicle into the West Columbia drug company’s headquarters.
Having found the location on the state Department of Health and Environmental Control’s website, the woman was there to receive a COVID-19 vaccine.
Nephron, along with Cayce-based Dominion Energy and two Lexington County road sign companies, Stay Alert Safety Services and Optec Displays, are donating time and services to put on a free drive-thru vaccine clinic. Eligible participants, age 65 or older, must have an appointment to receive a shot.
“I’m so proud we can do this,” Kennedy said.
While the vaccine itself is free, providers are legally able to bill people or their insurance for the doctor or pharmacy visit. Nephron is not charging.
With about 30 nurses on staff and almost as many doctors of pharmacy, the West Columbia drug maker applied for the certification needed to give the shots and administered its first 500 doses to Lexington County seniors inside its building over the week of Feb. 1.
It has 1,000 more doses to start giving out on Feb. 8, this time without people having to get out of their vehicles in an effort to make recipients more comfortable, Kennedy said.
When she first had the idea, she called Keller Kissam, president of electric operations at Dominion Energy South Carolina, to ask if they could use the power company’s vehicle turnaround area. Dominion’s headquarters a 10-minute drive from Nephron.
“Keller didn’t even hesitate,” Kennedy said. “It was ‘What can we do? How do we help?’ You talk about community spirit.”
In addition to the drive-thru space, Dominion is providing power to the site to power the computers needed to make appointments for recipients’ second doses. Stay Alert, Optec, as well as the town and county of Lexington are providing signage.
Those wishing to receive a vaccine from Nephron can go online to DHEC’s website in order to sign up for an appointment.
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.
"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.
Vigilent Labs to call Charleston, South Carolina home see more
Compliments of Charleston Post and Courier
Congratulations to our colleagues in Charleston County for this excellent announcement, advancing the growth of life sciences in South Carolina. Read the full story here.
A technology firm with ties to the U.S. defense industry said Thursday it will invest nearly $105 million in a facility on the former Navy base in North Charleston that the company says will manufacture COVID-19 test kits.
Vigilent Labs said it will hire 400 workers to produce FDA-approved test kits that can detect COVID-19 antibodies and antigens in 10 minutes or less.
Manufacturing will begin in December and the company said it also will move its headquarters to the site at 1105 Truxton Ave. Vigilent is currently based in Alexandria, Va., near the nation’s capital, and it was incorporated in Wyoming. Read on for full details.
Charleston, Vikor Scientific featured in national media see more
Empty hotel rooms, half-full offices, and shuttered retail. The coronavirus has wreaked havoc on the most established commercial real estate asset classes, creating short-term financial crunches and raising long-term secular concerns as remote work is tested and e-commerce rates rise.
Other asset classes, once alternatives, have become institutional investing gold standard. Logistics assets such as warehouses are providing a punch to the portfolio of the world’s largest landlord, Blackstone.
As industrial real estate investing becomes more crowded, and many of the other large asset classes slump, attention is turning to life sciences real estate — or space that’s used by pharmaceutical and biotech companies for research, development, and even manufacturing of new diagnostics, therapies, and vaccines.
The life science industry had been growing rapidly before the pandemic, attracting $17.4 billion in venture capital funding in 2019, up 370% from $3.7 billion in 2008, according to a Cushman & Wakefield report. Funding has continued to pour into the sector, even as coronavirus has slowed down venture funding overall, creating demand for more lab space.
Belimed Steam Sterilizers now announced compatible for crisis strategy decontamination of specific single-use N95 respiratorsBelimed collaborating with 3M manufacturing see more
Courtesy of Lowcountry Biz SC
Can N95 respirators be decontaminated in a steam sterilization cycle for reuse in situations of severe personal protective equipment (PPE) shortage? That question has been explored through collaboration between a world-leading respirator manufacturer, 3M, and a global leader in sterilization solutions, Belimed.
“The expert team at 3M was open-minded and very supportive in evaluating this question,” says Markus Auly, Head of Scientific Affairs at Belimed. “After two rounds of testing six different respirator models steam-treated by Belimed, and a thorough technical analysis of the data, 3M felt confident in the compatibility of the process with certain respirator models.”
3M’s latest version of the Technical Bulletin confirms that one standard 250° F sterilization cycle in Belimed Medical Steam Sterilizer models MST-H or MST-V does not compromise the form, fit, and function of their flat-fold respirators.
The benefit of evaluating and confirming compatibility with this standard steam sterilization process is that it is the gold standard among decontamination technologies because of its high microbiocidal efficacy, even in the presence of residual soils. From a resource standpoint, it is safe to use due to freedom from toxic residues, easy to administer, and has low processing costs, using only water and electricity.
Steam decontamination of N95 respirators will double the availability of 3M flat-fold respirators during a supply crisis in any healthcare center that has a Belimed Steam Sterilizer MST-H or MST-V.
During the global shortage in the last months, the supply of N95 respirators in all regions of the world, including healthcare leaders like the USA, Germany, or the Netherlands, has been tight. It soon became clear that disposing of single-use respirators after one use (standard protocol) could leave health care workers exposed due to lack of supply.
Hospitals around the world are seeking options to provide respirators to their employees to help reduce their risk of exposure when working with confirmed or suspected COVID-19 patients. The solutions include extended use and/or contingency reprocessing methods, both of which have their challenges.
Previously, Belimed had published a white paper explaining these reprocessing options that various countries were adopting to alleviate the scarcity of disposable personal protective equipment (PPE) like N95 respirators, surgical gowns, or face shields. The goal was to share this information with healthcare facilities across the globe. The whitepaper can be downloaded on the Belimed website.
Now, with the evaluation by 3M of steam decontamination of N95 respirators, specific programmed cycles of the Belimed Steam Sterilizer MST-H or MST-V were determined to be compatible with specific 3M respirator models.
“Belimed’s number one priority has always been to protect the health and safety of hospital staff and their patients. With our expertise in sterile processing we want to contribute our part and create certainty in uncertain times,” says Dominik Arnold, CEO of Belimed. “Now our customers and the healthcare community can be confident to have a more reliable fall-back solution in times of short supply of N95 respirators.”
For more information please check 3M’s technical bulletin “Decontamination of 3M Filtering Facepiece Respirators, such as N95 Respirators, in the United States – Considerations” and Belimed’s website (www.belimed.com).
Belimed AG is a leading provider of product and service solutions for the sterilization, disinfection, and cleaning of medical and surgical instruments. The company, with its headquarters in Zug (Switzerland), can look back on more than 50 years of history. We are continuously developing our technology-based portfolio and are always looking for innovative solutions to improve reliability, efficiency and sustainability in sterile supply departments.
We are engineers of confidence: we listen to our customers and find the right solutions for their challenges. We create optimal conditions for a better working environment. Our comprehensive range of sterile workflow solutions ranges from planning and conception to industry-leading systems and consumables to professional services and data connection options. In addition, we offer our customers training and further education opportunities.
The focus of our work is the unlimited trust of our customers. Together we make an important contribution to medical progress and ensure the safety and health of patients and medical personnel.
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.
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.
South Carolina firm's NP Collection Swab offers a highly scalable injection-molded design see more
South Carolina-based Hoowaki LLC has developed an innovative one-piece injection molded design for a COVID-19 swab to help close the gap in U.S. and global COVID-19 testing supplies. The 12-year old micro surface engineering and product solutions company has adapted its proprietary HOOWAKI MICROGRIP® surface technology to create micro-pillars used in the Hoowaki® NP Collection Swab that is shown in clinical user testing to meet existing industry-standard products for flexibility and performance. In independent laboratory testing (qPCR Assay) it has also been proven to be equivalent to the industry-standard flocked filament swabs in the collection of patient RNA that is critical for COVID-19 testing. Mass-production of its FDA registered, patent pending, Hoowaki® NP Collection Swab will begin this summer and is expected to reach at least several million units per month.
"The Hoowaki® NP Collection Swab is an important answer to the challenges posed by the global COVID-19 pandemic," said Ralph Hulseman, president of Hoowaki LLC. "Our design allows for production to be quickly scaled in communities around the world—rapidly addressing the rising demand for swabs, a critically important element of all COVID-19 testing."
A recent study by Harvard University [https://ethics.harvard.edu/files/center-for-ethics/files/roadmaptopandemicresilience_updated_4.20.20_0.pdf] cites the need for up to 20 million COVID-19 tests per day by the end of summer. The proprietary Hoowaki® NP Collection Swab is manufactured using advanced injection molding technologies that utilize existing equipment that is readily available in communities throughout the world. The swab's scalability is due to Hoowaki LLC's formulations and engineering designs working at existing injection molding facilities, which enables the swab to be produced in quantities that meet local demands anywhere in the world.
"Prisma Health collaborated with Hoowaki LLC in the testing and development of the innovative new design. The soft feel and ease of use of the Hoowaki® NP Collection Swab tip impressed my team," said Jennifer Meredith, Ph.D., clinical microbiology director at Prisma Health-Upstate.
"Prisma Health is excited to see a locally produced solution that could help ease the shortage of swabs for COVID-19 sample collection," said Meredith. "Hoowaki LLC's product has the potential to help us meet our commitment to our patients in the fight against COVID-19." Prisma Health, the largest healthcare system in South Carolina, harnessed its Rapid Innovation Task Force to help with the project.
Hulseman credits several public-private partnerships that have helped to provide start-up funding for the swab's development: "As is the case for many businesses in today's environment, Hoowaki LLC adapted quickly to meet new challenges where demand is outpacing supply so we could remain not only viable as a company, but also pursue this pioneering technology. We're grateful for the backing of the Greenville Local Development Corporation (GLDC) and SC Launch, Inc., an investment affiliate of the South Carolina Research Authority (SCRA), who have been instrumental in helping us develop the Hoowaki® NP Collection Swab."
"Hoowaki LLC is a great example of a small business that has proven to be a powerhouse of innovation during a time of incredible challenge," said David Barnett, Chairman of the Greenville Local Development Corporation. "We are proud of our continued support for Hoowaki LLC in the development of the NP Collection Swab."
Hoowaki, LLC is a micro surface engineering services and product solutions company that has developed unique micro surface pattern designs, engineering algorithms, software and manufacturing know-how to address major markets. The company's micro surface technology provides grip or slip solutions in the form of films for medical devices, packaging and other industrial and consumer products. Their team includes experienced micro surface engineers, physicists, friction experts, medical device experts, entrepreneurs, inventors and developers. Hoowaki has market deployment partnerships with Havi (packaging) and BvW Holding AG (implanted medical devices). Hoowaki has a broad patent coverage of micro surface technology.
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.