Rutgers University and Premier Medical Laboratory Services Conduct Studies Showing TAG-NGPM+™ Inactivates SARS CoV-2 Virus, Increases StabilityTogether, Rutgers and Premier are publishing a scientific article demonstrating their findings see more
Public Health Research Institute at Rutgers New Jersey Medical School and Premier Medical Laboratory Services (PMLS) have conducted studies on the stability and viral inactivation properties of the Truckee Applied Genomics (TAG) TAG-NGPM+ virus inactivating media. The studies show that the non-flammable solution contains a chemical make-up which may increase both room temperature stability and freeze-thaw integrity. This means that the specimen is better preserved during transit to a testing laboratory, and as a result, could increase the accuracy of testing results while decreasing the number of samples ruined by temperature changes. Rutgers’ data also shows that the patented TAG-NGPM+ inactivates SARS-CoV-2 in the specimen, making it safer for transport and handling by laboratory staff.
“PMLS is proud to participate in this collaborative effort with such great institutions as Rutgers and Truckee Applied Genomics,” said Austin Shirley, Director of Operations for Premier Medical Laboratory Services. “Effectively inactivating the SARS-CoV-2 virus and other pathogens before transporting them to labs, while also making the testing more accurate and the handling of the media safer, is a tremendous innovation in specimen collection.”
The TAG-NGPM+ media was developed based on the patented TAG-1™ Class 1 General Reagent. TAG-1 is a formaldehyde-free tissue fixative that was designed to improve molecular tests while requiring no changes to pathology workflows. The TAG-NGPM+ formulation adds sufficient and complementary anti-viral and anti-bacterial components. These components improve the safety of viral sample handling and provide safer and less costly media handling compared to other virus inactivating media since TAG-NGPM+ contains no guanidinium salts.
The studies conducted by PMLS show that the TAG-NGPM+ solution can also be used as an optimal transport media for COVID-19 sample testing. There was a 5 log10 reduction in the viral titer after treatment of SARS-CoV-2 virus with TAG-NGPM+ buffer within 30 minutes while the integrity of the viral RNA remained intact. This might potentially help centralized core laboratories and Point of Care (POC) laboratories safely process patient samples when access to BSL II facilities is limited. Another major advantage the buffer offers is in safe disposal in any disinfectant including 10% bleach solution, since the media is free of hazardous reactive chemicals like guanidinium isothiocyanate (GITC).
Drs. Padmapriya Banada and Sukalyani Banik conducted the studies in the Alland laboratory at Rutgers NJMS. According to Dr. Banada, “the TAG-NGPM+ transport media can potentially reduce the biohazard risk associated with COVID-19 testing, as practice that could otherwise expose laboratory personnel to live SARS-CoV-2, the virus that causes COVID-19. The study showed that the transport media inactivated SARS-CoV-2 at both room temperature and under refrigeration conditions at the tested concentrations. Studies by PMLS also showed that the transport media prolonged sample stability. By improving the safety and stability of COVID-19 test samples, the transport buffer should greatly simplify on-site or point of care testing in settings such as doctor's offices, workplaces or schools”
Dr. Tian Yu, TAG VP of Product Development commented, “TAG-NGPM+ virus inactivation media was designed to increase lab staff safety, while eliminating the need for a cold chain and protecting RNA integrity for weeks at ambient temperature. Because TAG-NGPM+ is designed to better stabilize viral RNA fragments and preserve protein structures, it will enable additional testing formats on top of molecular testing which are known to show high specificity in COVID19 diagnosis.“
The article by Rutgers NJMS and PMLS demonstrating their research findings is soon to be published. For more information, please call 866-405-2199 or visit www.PreMedInc.com.
ABOUT PREMIER MEDICAL LABORATORY
Premier Medical Laboratory Services (PMLS) is a CLIA and COLA regulated laboratory based in Greenville, South Carolina focused on providing clinically meaningful results to medical practitioners. Premier Medical Laboratory Services offers a variety of highly specialized tests including: the only Type II Diabetes molecular predisposition test available in the U.S., advanced cardiovascular testing, hereditary cancer screening, carrier screening, women’s health panels, pharmacogenomics, serum allergy testing, blood wellness, Hepatitis C genotyping, respiratory pathogens, gastrointestinal pathogens, and more. In addition to its specialty programs, Premier Medical Laboratory offers a comprehensive testing menu of general chemistry, immunoassay, and hematology tests. The company also is proud to offer a patient friendly billing policy. For more information, please visit www.PreMedInc.com or call 866-405-2199.
Trio collaborate to turn back COVID tides see more
It was not long ago when we all witnessed demand for critical Personal Protection Equipment (PPE) far outstripping supply on the front lines of the COVID-19 battle.
While this story line is now receding in our memory, it became a rare instance in South Carolina based on extraordinary efforts from entities like Humimic Medical, South Carolina Biotechnology Organization (SCBIO), and South Carolina Manufacturing Extension Partnership (SCMEP). Not only did these groups address frontline workers, but they also addressed the critical PPE needs of organizations a few layers back from the front lines – such as non-profit community outreach groups, church programs, and workforce development groups.
Humimic Medical teamed up with SCBIO and SCMEP to help these organizations and others out. Leveraging the broad network of SCBIO and connected distribution channels of SCMEP, Humimic Medical donated thousands of face shields to organizations across South Carolina which desperately needed quality, made-in-the-USA protective equipment.
“Helping the ‘little guys’ has always been part of my DNA, I guess,” commented Joel Edwards, CEO of Greenville’s Humimic Medical. “We started in a garage 10 years ago and grew from there. Organizations willing to support the little guy like us along the way helped us tremendously in getting to where we are today. So having the opportunity to give back and help others who may not be first in line to receive PPE supplies just felt right.”
Humimic Medical does not typically produce PPE. However, as they continued to become more deeply entrenched in the collaborative life science ecosystem network that SCBIO has forged in the Palmetto State (which includes groups like SCMEP), they realized they could join the fight against COVID-19. Early in the pandemic, Humimic Medical shifted some of its engineering and manufacturing resources from their medical trainer product lines to help supply PPE where it was needed most.
There was one problem though. Humimic Medical didn’t have the established distribution channels for PPE in South Carolina. That’s where SCBIO’s connection to SCMEP came into play. Organizations like SCMEP also serve as key players in South Carolina’s connected, collaborative, and growth-oriented network. SCMEP’s mission of helping state organizations improve their competitiveness, performance, and profitability provided a perfect backdrop for Humimic Medical to connect to organizations around our state who still desperately needed PPE supplies like face shields.
“SCMEP always prides itself in being a strategic resource for companies in our State”, shared Chuck Spangler, President of SCMEP. “We’re grateful we could leverage our network in collaboration with SCBIO and Humimic Medical to serve organizations in need.”
Added SCBIO Interim CEO Erin Ford, whose team was able to rapidly connect Humimic with key contacts to deliver the new face shields where they are needed most, “We continue to live our mission of being the life sciences industry convener, and that’s more important than ever right now.”
“Organizations SCBIO and SCMEP continue to be invaluable assets in our State,” said Edwards. “The rich, collaborative networks these kind of groups create are what will continue to make South Carolina a leader in new business development.”
About Humimic Medical:
Humimic Medical is a rapidly growing medical trainer and synthetic gel manufacturing company based in Greenville, SC. The company is driven by innovative product design, world-class customer service, and fueled by robust collaborative partnerships with universities and healthcare providers. Humimic Medical utilizes its proprietary synthetic gel blend to more closely represent human tissue elasticity and maintain recyclable/reusable qualities that no other product line currently offers delivered at a significantly lower price point than any existing products.
SCMEP is a private, non-profit group that serves as a proven resource to South Carolina businesses, providing them with a range of innovative strategies and solutions. An affiliate of the National Institute of Standards and Technology (NIST), SCMEP operates under the US Department of Commerce to promote innovation and industrial competitiveness. SCMEP uses a strategic, hands-on, partnering approach to help South Carolina companies improve their competitiveness, performance, and profitability in today’s increasingly demanding global economy.
Nation-Leading COVID-19 Variant Surveillance Initiative Now Underway: Premier Medical Laboratory ServicesPMLS launches one of the nation’s largest variant surveillance initiatives see more
The Biden Administration announced Friday a $1.7 billion investment to monitor new and emerging COVID-19 variants which could induce another pandemic wave. Concurrently, to combat these mutated strains, advanced molecular diagnostics laboratory, Premier Medical Laboratory Services announces their launch of one of the nation’s largest variant surveillance initiatives. Now conducting genomic sequencing of 6,000 specimens per day, PMLS plans to increase that number to 12,000 by May. The large amounts of data gathered by this initiative will help protect the population from a future surge and cases with increased severity of symptoms.
When speaking on Pfizer’s ability to adjust the vaccine for effective inoculation against the new variants, a Pfizer Executive said Saturday, “You can basically, within a couple of weeks, put a new sequence in.” In order to make these adjustments to vaccines, scientists developing them need genomic sequencing data on a large scale, like that being produced by PMLS.
Scientific Director of Clinical Genetics for PMLS, Vidhya Narayanan commented, “Sequening information and population studies can give us vital information regarding evolution of the COVID 19 virus and transmission pattern which otherwise can go unnoticed.”
The COVID-19 virus is structured so that inside each nucleocapsid protein is the viral genome, which over time can mutate for the virus to be more efficient at spreading and to potentially cause more severe illness than the original strain. Genomic sequencing decodes the genomes to learn about the virus and how it is evolving. Standard polymerase chain reaction (PCR) COVID-19 tests, which are most widely used for detection of the COVID-19 virus, are very specific to detecting the pathogens of the original COVID-19 strain. Next generation sequencing is able to detect new pathogens so that epidemiologists can study viral genome mutations to understand how they affect the viral characteristics of COVID-19 and to determine future health implications the novel variants may cause.
Because library prep instruments and genomic sequencers are in short supply, many laboratories spend hours conducting library prep and sequencing manually. With high throughput genomic sequencers and library prep instruments that automate the library prep and sequencing process, PMLS achieves a much higher capacity for genomic sequencing. By monitoring 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.
“We want to be proactive with these new variants in case any adjustments need to be made within the healthcare industry for patient care or new safety protocols need to be put into place,” said Kevin Murdock, Founder of Premier Medical Laboratory Services. “Data is the most vital piece in beating this pandemic, so we made this a top priority to aquire the most advanced sequencing equipment and top scientists to help monitor them.”
Of growing concern, among other variants, is the Indian variant (B.1.617), which has spread to the UK and made landfall in California approximately two weeks ago. This variant is potentially the catalyst for a recent surge of cases in India and is believed to have more rapid rates of transmission than the original strain like the UK variant (B.1.1.7) that is estimated 50 percent more than the standard form of SARS-CoV-2 which is also been shown to cause higher mortality rates. (1,2)
Other current known variants:
- Brazil (P.1)
- South Africa (B.1.351)
- California (B.1.427/B.1.429)
- New York (B.1.526)
The high-volume sequencing being conducted at PMLS follows suit with COVID-19 testing solutions they have provided as a laboratory with one of the highest testing capacities in the nation. Their ability to test over 300,000 specimens per day for COVID-19 paired with their rapid turnaround of accurate results is why they are the chosen laboratory to conduct testing for Human Health Services surge sites, large organizations, schools, athletic teams, and state health departments across the US.
According to the CDC, genomic surveillance can help detect variants with:
- Ability to spread more quickly in people
- Ability to cause either milder or more severe disease in people
- Ability to evade detection by specific diagnostic tests
- Decreased susceptibility to therapeutics that employ monoclonal antibodies
- Ability to evade natural or vaccine-induced immunity (3)
- Harvard Magazine https://harvardmagazine.com/2021/01/covid-19-variants
- Nature Research Journal: https://www.nature.com/articles/s41586-021-03426-1
- CDC: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance.html?CDC_l.html
For more information, please visit www.premedinc.com/ngs or call 1.866.800.5470.
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women’s Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DiabetestPredict. For more information, please visit www.PreMedInc.com
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.
Ahead of Spring Break, Makers of ZShield Product Line Offer Easy Way to Stay Safe, Avoid Coronavirus see more
Digital manufacturing company ZVerse, Inc., makers of the award winning ZShield line of face shield and face mask products, has launched a public service campaign aimed at promoting the best way to stay protected against the COVID-19 virus.
As Spring Break approaches and coronavirus cases remain high across the U.S., ZVerse is recommending a "Good-Better-Best" model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
ZVerse is recommending a “Good-Better-Best” model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
The simple model recommends wearing a face mask as a minimum, or good level of protection, followed by a face mask and a face shield combined for better protection. The best protection comes with wearing a filtered face mask combined with a face shield, according to the ZVerse model.
"Experts are warning of a new pandemic wave if people let down their guard during the upcoming Easter and Spring Break holidays and fail to protect themselves and their loved ones," said ZVerse Founder & CEO John Carrington. "At ZVerse, we have learned so much from our own customers and our own product development journey about how to stay safe. So, we created what we hope is a simple and easy guide for COVID-19 protection."
In addition to raising public awareness, ZVerse is recommending its model to city and state officials looking for an easy way to keep citizens safe.
"ZVerse has been a valuable member of South Carolina's business community for many years, and they really stepped up when they received the call to help combat the COVID-19 pandemic," said Columbia Mayor Steve Benjamin. "Their "Good-Better-Best" model is exactly what we need to not only further the decline of COVID-19 cases, but also build toward a return to normalcy where we work, learn and play in our local communities."
ZVerse designs, manufactures and sells a complete line of acclaimed PPE products popular with consumers, schools, employers and government entities - and often seen covering famous faces across Hollywood
For information about ZShield products and pricing, visit: https://zshield.com/collections/available-products.
ZVerse was founded in 2013 by John Carrington in Columbia SC. ZVerse, a digital manufacturing ecosystem, currently provides the only CAD as a Service (CADaaS) platform and designer marketplace. ZVerse recently launched the next generation of its Digital Manufacturing Enablement (DME) platform, an AI drive workflow solution - a category defining technology for digital manufacturing and OEMs. In 2020, in response to the COVID-19 pandemic, ZVerse adapted its business model to quickly produce and distribute its new personal protective equipment product, ZShield, to hundreds of thousands of citizens. To learn more visit zverse.com and zshield.com.
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.
Softbox a key player in battle to beat COVID see more
Softbox, a leading global innovator and provider of passive temperature control packaging solutions for the pharmaceutical, life science and cold chain logistics industries, is proud to support Pfizer in the distribution of Covid-19 vaccines through the supply of a high-performance temperature-controlled parcel shipper developed specifically for ultra-low temperature applications.
Softbox supported Pfizer with the development of the highly specialised and reusable ultra-low temperature (ULT) shipper to help them on the distribution of ultra-low temperature vaccines and storing them at Point of Use (POU) sites.
Ultra-Low Temperature vaccines, such as that developed by Pfizer – BioNTech, uses mRNA (messenger RNA) technology and must be stored at temperatures between -90°C to -60°C to ensure that the vaccine’s quality and efficacy is maintained. The ULT shipper is capable of maintaining the required temperature during shipping of Covid-19 vaccines between -90°C to -60°C for at least 10 days unopened.
The highly innovative shipper utilises high performance insulation materials, incorporated in a robust and reusable construction, in conjunction with dry ice, to ensure long term ultra-low temperature control. Based on current guidelines, the Softbox ULT Shipper can be opened twice a day, for up to three minutes at a time. This allows clinicians at Point of Use (POU) sites to access the vaccine vials required for each day’s immunisation clinics without exposing the remaining vaccine stored within the shipper to ambient temperatures, thus ensuring integrity of the vaccine is maintained.
When correctly managed, the ULT Shipper can be used to store vaccines for in excess of 30 days. Through a process called “Re-Icing” the dry ice in the Softbox ULT Shipper can be topped up ensuring maximum thermal protection of the highly temperature sensitive mRNA vaccines.
“Softbox’s extensive knowledge and experience in temperature control packaging solutions and the cold chain industry was the right choice for us. They immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine, and quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.” said Tanya Alcorn, Vice President, Biopharma Global Supply Chain for Pfizer. “Their technical capabilities and innovative approach helped us achieve an excellent result in a very short period of time.”
Kevin Valentine, CEO of Softbox, said: “We are immensely proud to be playing such an important role in the fight against Covid-19. We worked extremely hard during 2020 to help Pfizer develop this highly innovative ULT shipper; establishing one of the world’s largest fleets of reusable temperature-controlled parcel shippers in the process and setting up two world-class service centres to support ULT shipper refurbishment.”
“It’s a huge honour to have the opportunity to support the distribution of these vital vaccines at the right temperature, maintain their integrity and help save millions of lives.”
For more information about Softbox visit: www.softboxsystems.com
Softbox is an award-winning temperature control packaging innovator that has been designing and producing high performance passive temperature control packaging solutions for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout Europe, North America, Latin America, India and Asia Pacific.
We have formed long standing partnerships with the world’s leading pharmaceutical, clinical research, biotech and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive clinical trial and commercialised products.
For more information about Softbox visit: www.softboxsystems.com
Johnson & Johnson COVID-19 Vaccine Authorized by FDA; First Single-Shot Vaccine in Fight Against Global PandemicShipping vaccine immediately, delivering more than 20 million doses to U.S. in March see more
Johnson & Johnson (NYSE: JNJ) (the Company) has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.
“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”
$30.2 million investment will create 425 new jobs see more
Pall Corporation (Pall), a global leader in filtration, separation and purification, today announced plans to establish operations in Spartanburg County. The company is creating 425 new jobs and investing $30.2 million into a new facility that will support the rapid development and production of vaccines and therapeutics, including a COVID-19 vaccine.
Pall serves the needs of customers across the broad spectrum of life sciences and industry and works with clients around the world to advance health, safety and environmentally responsible technologies.
Located at 816 Berry Shoals Road in Duncan, Pall's new facility will focus primarily on single-use technology such as the Allegro™single-use platform.
The facility is expected to be operational in May 2021. Individuals interested in joining the Pall team should visit the company's careers webpage.
The Coordinating Council for Economic Development has approved job development credits related to the project.
"Spartanburg County provides Pall with the diverse workforce we need to manufacture life-saving therapeutics and vaccines. We look forward to building our presence in this county." -Pall Life Sciences President Joseph Repp
"Pall Corporation's decision to invest into South Carolina comes at a time when our life sciences sector has evolved into one of our fastest-growing industries. The continued development of life sciences will create high-paying jobs that will ensure wellness and prosperity in South Carolina for years to come." -Gov. Henry McMaster
"We could not be happier with Pall Corporation's decision to invest in Spartanburg County. We welcome this globally recognized company to South Carolina, and we look forward to partnering with them going forward." -Secretary of Commerce Bobby Hitt
"The decision by Pall Corporation to come to Spartanburg is a win for our county, and a win for our budding life sciences sector. The variety of investments coming into our county, and the diversity of the industries that now call Spartanburg home, is a sign that our future is bright in the years to come." -Spartanburg County Councilman and Chairman of the Economic Development Committee David Britt
Governor McMaster Issues Proclamation Recognizing South Carolina Life Sciences Week to Celebrate State’s Fastest-Growing IndustryGovernor salutes industry during record-setting SC Life Sciences Conference see more
SOUTH CAROLINA – February 16, 2021 – In recognition of the importance of the life sciences industry in South Carolina, Governor Henry McMaster today issued a proclamation recognizing February 15-19, 2021 as South Carolina Life Sciences Week in the Palmetto State.
Governor McMaster made the announcement just steps from where SCBIO organizers were putting the finishing touches on Day 1 of the largest-ever life sciences gathering held – virtually of course -- in the state. A record 600 registrants from across America and around the globe are attending the virtual SCBIO gathering of South Carolina’s life sciences community – and celebrating the contributions of its 800+ organizations in helping America and the world overcome the challenging COVID-19 pandemic.
“South Carolina has developed a strong reputation as an emerging leader in the life sciences,” said Governor McMaster. “Our innovative companies and exceptional workforce are key drivers in strengthening our economy and creating new opportunities for South Carolinians. With an incredible pace of growth in the industry here, we know that the life sciences will continue to play a critically important role in our state’s economic success for generations to come.”
Governor McMaster made the proclamation in downtown Greenville, in the heart of the county which possesses the state’s largest concentration of life sciences companies, although the industry boasts life sciences organizations in 42 of South Carolina’s 46 counties currently. Governor McMaster was flanked by leadership and Board members of SCBIO, South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, innovating and growing the life sciences industry in the state.
Life sciences has a $12 billion economic impact in the Palmetto State, with more than 800 firms involved and over 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products. It also represents a significant economic development focus for the state, with strong life science recruiting initiatives led by the South Carolina Department of Commerce and other regional economic development teams.
South Carolina life sciences has seen a doubling of firms and 40% increase in life sciences’ direct employment since 2017, which combine to make it the fastest growing industry sector in the state, according to recent data provided by Dr. Joseph Von Nessen, the state's research economist and noted economic development expert with the Moore School of Business at the University of South Carolina.
“Life sciences is a major driver of South Carolina’s economy today, and this conference is testament to the industry’s surging impact, reach and rapidly rising economic significance in our state and country,” noted SCBIO President and CEO Sam Konduros. “We’re honored by Governor McMaster’s recognition, and appreciate his personal support for the contributions that life sciences are making to improve quality of life, care and economic standing for South Carolina citizens.”
For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.
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.
Single shot may be enough for AZ vaccine see more
Britain’s health chief says a new study showing that a single dose of the COVID-19 vaccine developed by Oxford University and AstraZeneca provides a high level of protection for 12 weeks supports the government’s strategy of delaying the second shot so more doses can be delivered to more people.
Health Secretary Matt Hancock’s comments came after Oxford released a study showing the vaccine cut transmission of the virus by two-thirds and prevented severe disease. The study has not been peer-reviewed yet, but it was greeted with excitement by U.K. officials under pressure to justify their decision to delay the second dose.
“That reduction in transmission, as well as the fact there is no hospitalizations, the combination of that is very good news. And it categorically supports the strategy we’ve been taking on having a 12-week gap between the doses,” Hancock told Sky News on Wednesday.
One of the lead researchers on the project, Dr. Andrew Pollard of Oxford University, said Oxford scientists believe the vaccine will continue to offer protection against new variants of COVID-19, although they are still waiting for data on this.
Even if the virus adapts, “that doesn’t mean that we won’t still have protection against severe disease.’’
“If we do need to update the vaccines, then it is actually a relatively straightforward process it only takes a matter of months, rather than the huge efforts that everyone went through last year to get the very large-scale trials run,” he told the BBC.
Softbox Systems the partner of choice for Pfizer vaccine see more
Greenville is the North American headquarters for Softbox, the British manufacturer of the insulated containers critical to the stability of the Pfizer vaccine.
“I consider this the start to the finish as we move into this process of trying to get enough immunity into the community,” Dr. Steve Shelton said as the dry ice-laden Softbox made a triumphant arrival at Prisma Health-Midlands, complete with pom-poms and cheering health care workers. Shelton is an emergency room physician with Prisma Health who spearheaded COVID-19 treatment efforts in the Midlands.
“I know there is a lot of anxiety about this, but I am confident in the FDA in making sure that they have approved an effective vaccine,” he said. “I feel like I am honored to be here to receive this and am doing my part to combat this disease.”
To remain effective, the vaccine must be shipped at temperatures colder than most of Antarctica, in a box with more layers than a Russian doll. The Softbox includes a top layer or “pod” of dry ice housed on top of five trays of the vaccine, which in turn, nests in a carrying box with a foam lid and temperature gauge. All this is fitted in a cardboard shipping container, according to a Dec. 3 manual from Pfizer.