RE:RE:RE:RE:FDA EUA Speed of Review in 1st 9 month… With the new Sept 23 FDA EUA changes, looks like all the Antigen Tests will have to share actual test data against the Covid19 variants. And change up the legalese on their packaging in 3 months. If you read most of their websites, it's not clear they have "actually tested” for variants. And also now either have to sticker or re-print some new legalese on their kit packaging. Check it out.
Therma’s probably done it all, as they had additional questions to answer, which probably included the Sept 23 FDA EUA changes…. Right time, right place for them. The other 20 now need to step up and make these changes. 90 days... clock is ticking.
Back to the testing on variants… ... check out Abbott…. Aug. 10, 2021 (https://www.abbott.com/corpnewsroom/diagnostics-testing/monitoring-covid-variants-to-ensure-test-effectiveness.html)
"Abbott is intently monitoring the mutations of COVID-19 so we can ensure our tests can detect them. We have conducted a thorough analysis of the new variants, including the Delta variant, and we are confident that our tests remain effective. The Delta variant, along with all other variants of concern, are primarily defined by mutations in the spike protein. Abbott's diagnostic tests do not rely on the spike proteins to detect the virus, which means that these new variants do not affect test performance."
Nothing on Abbott’s website says they have "actually tested”, just conducted an analysis and are confident their test will detect variants including Delta. This is what I call PR Soft Spin!!!
Note: "...their test" - singular. 1 test
Again, the new Sept 23 FDA EUA requirements for Antigen tests (and all tests) say you have to actually perform test verification on variants. And also add statements to test procedure documents and packaging.
I’m very glad Therma has actually tested AcuVid on all the key variants …. Therefore, I think they will be up next on the FDA EUA Antigen Test List, as they did actual tested per multiple releases, including July 8 - “Therma Bright's AcuVid™ saliva test has successfully detected not only the original virus, but the P.1 and P.2 variants discovered in Brazil, the B.1.1.7 variant from the UK and now the highly-contagious Delta B.1.617.2 variant from India.”
Anyway, again only 20 companies in 18 month have 1 test each for a total of 20 antigen tests with 34 submissions for variations… I don’t see new ones hitting the FDA EUA List before THRM . Plus, as data shows the simpler solutions - PCR & Antibody - are being done in greater quantity … which requires pricy $$$ testing machinery, lab technicians, and time for result reporting…
People want test results fast. 15 minute rapid test. People will want AcuVid Covid19 Rapid Antigen Saliva Test! ... over nasal rapid tests... hands down.
Aug. 10, 2021 (https://www.abbott.com/corpnewsroom/diagnostics-testing/monitoring-covid-variants-to-ensure-test-effectiveness.html) Abbott is intently monitoring the mutations of COVID-19 so we can ensure our tests can detect them. We have conducted a thorough analysis of the new variants, including the Delta variant, and we are confident that our tests remain effective. The Delta variant, along with all other variants of concern, are primarily defined by mutations in the spike protein. Abbott's diagnostic tests do not rely on the spike proteins to detect the virus, which means that these new variants do not affect test performance.
Nothing on Abbott’s website says “they have actually have tested”, just conducted an analysis of Delta.
New Sept 23 FDA EUA requirements for Antigen tests say you have to actually perform test verification .
Glad Therma has actually tested all the key variants …. I think they are up next, as the did P1,P2, Delta and others