COVID-19 contracts in the United Kingdom

GenBody America Receives Amendment to FDA Emergency Use Authorization for Updated Point-of-Care Test Kits with Individual Reagents

Retrieved on: 
Thursday, September 1, 2022
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Were very pleased that the FDA has amended our authorizations, said David Yoo, CEO of Genbody America.

Key Points: 
  • Were very pleased that the FDA has amended our authorizations, said David Yoo, CEO of Genbody America.
  • Were proud to offer a new level of accessibility with our point-of-care kits that equips our customers with individual reagents.
  • GenBody America is the U.S. manufacturer for GenBody, Inc. , a leading South Korean manufacturer of rapid diagnostic tests and reagents for point-of-care applications for COVID-19 and other diseases.
  • The GenBody COVID-19 Ag Test has been authorized by the FDA under an EUA for use by authorized laboratories, pending full FDA clearance.

Preparing for Continuing Battle with COVID, MicroGEM Partners with Medline to Equip Healthcare Providers with World's First Saliva PCR Test for Point of Care

Retrieved on: 
Wednesday, August 17, 2022
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CHARLOTTESVILLE, Va., Aug. 17, 2022 /PRNewswire/ -- MicroGEM, a U.S.-based molecular biology company, today announced that Medline, a manufacturer and distributor of medical supplies to healthcare providers across the continuum of care, is now offering the MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test.

Key Points: 
  • "Our partnership with MicroGEM expands our product portfolio to offer a saliva-based test for the first time.
  • Medline is a healthcare company; a manufacturer, distributor, and solutions provider focused on improving the overall operating performance of healthcare.
  • Partnering with healthcare systems and facilities across the continuum of care, Medline provides the clinical and supply chain resources required for long-term financial viability in delivering high-quality care.
  • Headquartered in Northfield, Ill., Medline has 30,000+ employees worldwide and does business in more than 125 countries and territories.

FDA Grants Extension of Shelf-life & Expiration Date for GenBody COVID-19 Ag Test

Retrieved on: 
Thursday, August 4, 2022
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This extension was granted after FDA review of long-term studies demonstrating that the GenBody tests maintain their performance long after the initially defined 12-month window.

Key Points: 
  • This extension was granted after FDA review of long-term studies demonstrating that the GenBody tests maintain their performance long after the initially defined 12-month window.
  • Ensuring the consistent performance of the GenBody test device over time is critical, said Dr. Andrew Kim, Chief Medical Officer of GenBody America.
  • GenBodys COVID-19 antigen test is one of a handful of visually readable tests that is EUA authorized by the FDA.
  • The GenBody COVID-19 Ag test has been authorized by the FDA under an EUA for use by authorized laboratories, pending full FDA clearance.

Qorvo® Biotechnologies Receives FDA Emergency Use Authorization (EUA) for Rapid COVID-19 Antigen Testing at the Point of Care

Retrieved on: 
Thursday, August 4, 2022
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The FDA previously granted an EUA for use in moderate and high complexity settings such as laboratories.

Key Points: 
  • The FDA previously granted an EUA for use in moderate and high complexity settings such as laboratories.
  • This EUA significantly expands the market for Qorvo beyond laboratories to include physician offices, urgent care centers, retail pharmacies, employee health testing, and any other locations where CLIA waived tests can be performed.
  • The Qorvo Omnia platform provides a unique combination of performance, automated workflow and scalability to serve on-site testing needs in a very efficient manner."
  • Qorvo is a registered trademark of Qorvo, Inc. in the U.S. and in other countries.

NSR’s Satellite Capacity Report Sees Industry Moving Past COVID-19 Contraction to Drive $207B in Revenue Amidst Competition, Innovation and Risk-Taking

Retrieved on: 
Wednesday, July 27, 2022
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Competition, innovation and risk-taking from all player types anchors a space economy currently at the beginning of a growth trajectory.

Key Points: 
  • Competition, innovation and risk-taking from all player types anchors a space economy currently at the beginning of a growth trajectory.
  • The first wave of LEO constellations is being realized with Starlink and OneWeb half-way through their first-generation constellation build-ups.
  • Despite industry hype, the disrupting potential of these initial deployments is limited, notes NSR Principal Analyst and report author Lluc Palerm .
  • The Asia region offers massive Satcom opportunity, especially in bridging the digital divide, states NSR Senior Analyst & report co-author Vivek Suresh Prasad .

Nanomix Receives CE Mark for its eLab COVID-19 Rapid Point-of-Care Antigen Panel

Retrieved on: 
Friday, May 20, 2022
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The COVID-19 antigen test cartridge is used with the Nanomix eLab Analyzer to provide qualitative results in 15 minutes from an anterior nasal swab.

Key Points: 
  • The COVID-19 antigen test cartridge is used with the Nanomix eLab Analyzer to provide qualitative results in 15 minutes from an anterior nasal swab.
  • Receiving the CE mark for our COVID-19 rapid antigen test is a key milestone which further validates our rapid and accurate point-of-care (POC) testing technology, stated John Hardesky, Chief Commercial Officer of Nanomix.
  • The Nanomix COVID-19 rapid antigen test provides qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal (anterior nares) swabs.
  • Additionally, the eLab system can publish Nanomix eLabCOVID-19 rapid antigen test results output as a QR code for privacy.

Pond Lehocky Giordano Successfully Obtains Workers' Compensation Benefits on Behalf of Widow in Fatal COVID-19 Claim

Retrieved on: 
Thursday, April 14, 2022
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PHILADELPHIA, April 14, 2022 /PRNewswire-PRWeb/ -- Jerry M. Lehocky, a founding partner of Pond Lehocky Giordano LLP, recently obtained a favorable court ruling from a Workers' Compensation Judge on behalf of a widow whose husband passed away from COVID-19 after being exposed to the virus at work. The case is Estate of Henry Koffa, Sr., v. Merakey, Workers Compensation Office of Adjudication - Springfield, PA office, WCAIS #8513607.

Key Points: 
  • PHILADELPHIA, April 14, 2022 /PRNewswire-PRWeb/ -- Jerry M. Lehocky , a founding partner of Pond Lehocky Giordano LLP, recently obtained a favorable court ruling from a Workers' Compensation Judge on behalf of a widow whose husband passed away from COVID-19 after being exposed to the virus at work.
  • The case is Estate of Henry Koffa, Sr., v. Merakey, Workers Compensation Office of Adjudication - Springfield, PA office, WCAIS #8513607.
  • As a result, Mr. Lehocky was able to obtain fatal claim benefits for the deceased's widow.
  • Pond Lehocky Giordano LLP is the largest workers' compensation, Social Security disability, and short- and long-term disability law firm in Pennsylvania.

APHL Awarded NIH Contract for Reporting OTC COVID-19 Results to Public Health Agencies

Retrieved on: 
Wednesday, March 30, 2022
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Silver Spring, MD, March 30, 2022 (GLOBE NEWSWIRE) -- The Association of Public Health Laboratories (APHL) was recently awarded a contract not to exceed $8.8 million over three years by the National Institutes of Health (NIH) National Institute of Biomedical Imaging and Bioengineering (NIBIB) to employ the AIMS+ solution for reporting over-the-counter (OTC) COVID-19 test results to local, state and federal public health agencies.

Key Points: 
  • Silver Spring, MD, March 30, 2022 (GLOBE NEWSWIRE) -- The Association of Public Health Laboratories (APHL) was recently awarded a contract not to exceed $8.8 million over three years by the National Institutes of Health (NIH) National Institute of Biomedical Imaging and Bioengineering (NIBIB) to employ the AIMS+ solution for reporting over-the-counter (OTC) COVID-19 test results to local, state and federal public health agencies.
  • While OTC tests provide valuable opportunities for consumers to get quick results, it remains vital that results are reported to local, state and federal public health agencies for continued disease surveillance.
  • As at-home tests for other diseases become commonplace as well, this partnership with NIH presents significant public health data reporting opportunities beyond only COVID-19.
  • The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the publics health in the U.S. and globally.

Visby Medical Executes Contract Option with BARDA for $25.5M to Develop Rapid Flu-COVID PCR Test Designed for At-Home Use

Retrieved on: 
Friday, March 25, 2022
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SAN JOSE, Calif., March 25, 2022 /PRNewswire/ -- Visby Medical™, a leading medical diagnostic company, today announced that it has received an additional $25.5M in federal funding to develop and validate an at-home combination Flu-Covid test from the Biomedical Advanced Research and Development Authority (BARDA).The developmental-stage Flu-COVID PCR Test is a single-use, handheld, all-in-one PCR device that detects and distinguishes between influenza A, influenza B, and SARS-CoV-2 from one sample, delivers results in less than 30 minutes, and requires no additional equipment. This incremental funding builds on the initial contract, announced February 2, 2021.

Key Points: 
  • Designed for ease-of-use with minimal set-up time, the test offers a fast sample-to-result time of less than 30 minutes with an expected accuracy rate similar to lab-based PCR tests.
  • In the first phase of the contract, BARDA-supported efforts to obtain FDA emergency use authorization for Visby's rapid, single-use Flu-COVID PCR Test in CLIA-waived point of care settings.
  • The Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases.
  • Visby Medical is accelerating the delivery of fast and accurate, palm-sized PCR diagnostics to the point of care, and eventually for use at home.

GenBody America’s Diagnostic Kit Manufacturing Plant Opens and Begins Production in Southern California

Retrieved on: 
Monday, March 7, 2022
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GenBody America , LLC, the U.S. affiliate of GenBody, Inc., a Korean corporation, today announced that it has opened and ramped up production at its Jurupa Valley, California factory.

Key Points: 
  • GenBody America , LLC, the U.S. affiliate of GenBody, Inc., a Korean corporation, today announced that it has opened and ramped up production at its Jurupa Valley, California factory.
  • The facility has the capability to produce 1.5 million visually readable anterior nasal swab COVID-19 antigen test kits per week.
  • Additionally, GenBody America will be adding approximately 100 jobs in the Southern California region with this new manufacturing facility.
  • With more than 60 diagnostic test manufacturers, its an honor for GenBody to be chosen by Samsung.