Todos Medical’s CLIA/CAP Lab Provista Completes Validation of High-Capacity SARS-CoV-2 Variant Testing Service Capable of Identifying Known Variants
Company sees a significant market opportunity for reference lab agreements to identify which variant is responsible for positive COVID-19 test results Validation paves the way for launch of variant testing at Provista in September 2021
New York, NY, and Tel Aviv, ISRAEL, Aug. 26, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP certified lab Provista Diagnostics has successfully completed the validation studies required to put the Kogene Biotech PCR Variant Test Kit (‘Kogene Variant Kit’) into production and expects to launch variant testing in September 2021. The Kogene Variant Kit is a PCR kit capable of identifying the key mutations associated with specific SARS-CoV-2 variants, including the key P681R mutation identified in the Delta variant, that allows Todos to categorize the lineage of the strain responsible for a positive test result. The test can be completed in as little as one hour, significantly faster than genome sequencing, and is highly scalable with the Tecan® liquid handling automation currently onsite at Provista.
“With the rising number of breakthrough infections caused by the Delta variant that now represents approximately 96% of cases, up from 3% in early July 2021, it has become extremely clear that the United States’ genomic sequencing capabilities are unable to keep up with the sheer volume of demand for classifying which variants are responsible for SARS-CoV-2 infections,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Not only is there significant public health interest in tracking variants, there is also an emerging clinical difference in how physicians may speed the prescription of certain treatments based upon which variant a patient has. This clinical utility, initially seen with the Alpha variant and now more pronounced with the Delta variant, means that we must prepare for the future where we expect new variants, such as the Lambda variant, that appear more capable of escaping vaccination protection and may result in more aggressive treatment strategies. The ability for Provista to scale this test offering rapidly with our automation by reflexing positives for variant analysis and by expanding our reference lab network to confirm which variants are responsible for other labs’ positive results will improve regional understanding of the spread of new variants as they emerge, and provide schools, businesses, and public health officials an ability to react more quickly with policy changes.”
Todos sees a large market opportunity developing for variant testing that will further expand upon the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020. Provista Diagnostics has the automation in place to do up to 20,000 PCR tests, over 1,500 cPass tests per day and can complete over 5,000 variant tests per day when at full capacity. The CMS reimbursement rate per PCR test is $100, and best practices indicate that labs can bill for an additional PCR test to confirm the variant associated with a positive when using the Kogene Variant Kit. To date, over 37 million people in the United States have tested positive for COVID-19, and with the rate of breakthrough infections rapidly increasing, tracking variants of interest and of concern is now urgently needed.
https://investor.todosmedical.com/news-events...-completes
Company sees a significant market opportunity for reference lab agreements to identify which variant is responsible for positive COVID-19 test results Validation paves the way for launch of variant testing at Provista in September 2021
New York, NY, and Tel Aviv, ISRAEL, Aug. 26, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP certified lab Provista Diagnostics has successfully completed the validation studies required to put the Kogene Biotech PCR Variant Test Kit (‘Kogene Variant Kit’) into production and expects to launch variant testing in September 2021. The Kogene Variant Kit is a PCR kit capable of identifying the key mutations associated with specific SARS-CoV-2 variants, including the key P681R mutation identified in the Delta variant, that allows Todos to categorize the lineage of the strain responsible for a positive test result. The test can be completed in as little as one hour, significantly faster than genome sequencing, and is highly scalable with the Tecan® liquid handling automation currently onsite at Provista.
“With the rising number of breakthrough infections caused by the Delta variant that now represents approximately 96% of cases, up from 3% in early July 2021, it has become extremely clear that the United States’ genomic sequencing capabilities are unable to keep up with the sheer volume of demand for classifying which variants are responsible for SARS-CoV-2 infections,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Not only is there significant public health interest in tracking variants, there is also an emerging clinical difference in how physicians may speed the prescription of certain treatments based upon which variant a patient has. This clinical utility, initially seen with the Alpha variant and now more pronounced with the Delta variant, means that we must prepare for the future where we expect new variants, such as the Lambda variant, that appear more capable of escaping vaccination protection and may result in more aggressive treatment strategies. The ability for Provista to scale this test offering rapidly with our automation by reflexing positives for variant analysis and by expanding our reference lab network to confirm which variants are responsible for other labs’ positive results will improve regional understanding of the spread of new variants as they emerge, and provide schools, businesses, and public health officials an ability to react more quickly with policy changes.”
Todos sees a large market opportunity developing for variant testing that will further expand upon the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020. Provista Diagnostics has the automation in place to do up to 20,000 PCR tests, over 1,500 cPass tests per day and can complete over 5,000 variant tests per day when at full capacity. The CMS reimbursement rate per PCR test is $100, and best practices indicate that labs can bill for an additional PCR test to confirm the variant associated with a positive when using the Kogene Variant Kit. To date, over 37 million people in the United States have tested positive for COVID-19, and with the rate of breakthrough infections rapidly increasing, tracking variants of interest and of concern is now urgently needed.
https://investor.todosmedical.com/news-events...-completes
