Why is the Seegene COVID molecular genetic test not approved by the FDA?
Why is the Seegene COVID molecular genetic test not approved by the FDA? Today's Google search with the the two keywords: FDA + Seegene returned an article (12-March indicating that the Seegene COVID 19 test is not FDA approved:
FDA Has Not Approved South Korea COVID-19 Testing Kit Fast Automated Multiple Testing Genes, People
Was the test evaluated by the FDA? I would think that there is more than enough sample data having been fielded in KR. What rigors did FDA approval of the Roche COVID test meet?
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The linked post (which reads to me rather like rant than a news post) not the underlying CNN article indiate that the manufacturer actually applied for FDA EUA (Emergency Use Approval). Without such an application, there (rather obviously) won't be an approval.
Was the test evaluated by the FDA?
The clinical evaluation needs to be done by the manufacturer, not by the FDA. The FDA then evaluates the results submitted by the manufacturer with ther EUA application.
The test is not on the FDA page that lists approved tests.
We don't know why. E.g., whether they it did not pass the FDA EUA requirements (I'd think that unlikely) or the manufacturer never applied (which may be totally sensible for several reasons, e.g. if their manufacturing capactity is such that all the tests they produce are bought, say, in East Asia)
What rigors did FDA approval of the Roche COVID test meet?
see the FDA FAQ on getting EUA and requirements for using a test even before that EUA is in place on the general requirements and
the Roche test Manufacturer's instructions listing their validation results in particular.
FDA explicitly says that they want the manufacturer to be in early contact with them.
A few more thoughts:
It is not only the test kit that needs approval, the test kit gets approved for use with certain extraction equipment (manufacturer & possibly model) and also the lab needs certain approval.
It may be that in East Asia different machines (other manufacturers) are used, so that the South Korean approval cannot be used for evaluating performance with the machinery predominantly used by US labs.
The first EUA for the CDC Covid test was granted by the FDA on Feb. 4th. I.e., one day before Seegene had their first test kit according to the CNN post and thus more than a week before the Seegene test got South Korean fast-track approval.
That such a test with fast track validation may turn out not to be that great after all is a known risk which is accepted in the current situation in order to have tests available at all. We still would not expect faulty reagents in the test kit, though.
Theres nothing that unique about the South Korean test manufacturer. There are other manufacturers and also ones that were apparently even earlier (sent out first [unapproved] tests on Jan 10th) than the South Koreans, see e.g. this new post about a Berlin manufacturer of such tests (in German). This news post reads very similar to the South Korean, just with a different company.
We also don't know yet how long/where which test will perform well as mutations of the virus will happen - and they may affect the performance of some tests but possibly not others. The Berlin test manufacturer discusses this in another newspaper article/interview.
AFAIK, other test kits also don't require manual PCR - whether in some countries the testing is done manually because the local approved labs don't have automated extraction/PCR machinery in place is a totally different question.
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