RE: The RNS actually says....?13 Jan 2022 09:44
This is from the FDA website. TT completed mid December. Switch out only taking place now which is why I believe it's about doing the switch when Distributor/warehouse stocks are low/depleted and production can be halted to make the switch. They added the US link to qualify it was due to them not the UK. Medusa19 are working to get FDA approval and I think that's also why their website has been updated so awkwardly. They knew the tweak was coming and it won't be long and at the same time they wanted Meduflow to be seen to be available for pro use so they could move stocks pre update...it all looks very odd right now but that's because we PIs are being forensic.
'Revision Concerning Viral Mutations
On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test’s performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.
The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s). If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The EUA holder must also update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.'
Sign In
Follow the stocks
