Todos Medical Announces US FDA Emergency Use Authorization Allowed for Gnomegen COVID-19 PCR Test Kits
GLOBENEWSWIRE 9:11 AM ET 4/21/2020
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Gibraltar Brothers & Associates, LLC has entered into agreements with Gnomegen, LLC to supply Todos with its proprietary Real Time digital PCR Test Kits for COVID-19
REHOVOT, Israel, SINGAPORE and NEW YORK, NY, April 21, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Todos Medical Ltd.(TOMDF), a commercial in vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, as well as point-of-care and lab-based tests for COVID-19, today announced that Gnomegen LLC (“Gnomegen”) has received Emergency Use Authorization (“EUA”) from the US Food & Drug Administration (FDA) for its real-time digital polymerase chain reaction (RT-Digital PCR Detection) diagnostic test for COVID-19. Gibraltar Brothers & Associates, LLC, a US-based subsidiary of Shanghai Liangrun Biomedicine Technology Co., has added Gnomegen as a supplier of PCR Test Kits to Todos under Gibraltar’s existing agreements with Todos, thereby allowing Todos to use the Gnomegen PCR Test Kits for its CLIA laboratory services business, as well as for distribution through Todos’ network.
Todos is currently validating Gnomegen’s PCR Test Kits in its partner CLIA lab (Provista) where it is also in validation for automated extraction machines to achieve High Throughput status with Centers for Medicare and Medicaid Services (CMS). On April 15, 2020, CMS increased its payment rates for High-Throughput SARS-CoV-2 diagnostic tests that use high-throughput technologies allowing for increased capacity and faster results to $100 per test. A High-Throughput testing lab can process at least 200 specimens per day using “highly-sophisticated equipment that requires specially trained technicians and more more-intensive processes to assure quality,” according to CMS. Provista expects that it can scale up to a capacity of up to 2,000 PCR diagnostic tests per day in May 2020. Provista intends to offer lab services for customers who utilize a variety sample collection methods, including oropharyngeal, nasopharyngeal, stool and saliva.
“We are very pleased to see Gnomegen’s PCR Test Kits achieve EUA status with the US FDA,” said Gerald Commissiong, President & CEO of Todos. “Gnomegen’s highly sensitive RT Digital PCR test kits are especially promising given the high sensitivity for RT digital PCR. This will be a great addition to our partner 3D Med’s automated extraction machine which allows for significantly increased throughput over traditional lab workflows. We expect to begin offering PCR services in May to qualified customers with a view towards being a lab partner of choice for our antibody test kit customers who need confirmatory results.”
About the SARS-CoV-2 Coronavirus (COVID-19)
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries worldwide. COVID-19 is the disease caused by SARS-CoV-2.
About Todos Medical Ltd.(TOMDF)
Headquartered in Rehovot, Israel, Todos Medical Ltd.(TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The
