FDA Warns Antibody Based COVID-19 Tests Are Not “Approved”
[Thursday, April 9, 2020] In about 3 weeks since FDA announced a policy under which serological tests could be sold with just a notification of intent to file an EUA, more than 70 companies have filed this notification and started selling diagnostic tests that measure anti-coronavirus antibodies. However, these tests must carry a disclaimer that the test has not been reviewed by the FDA and that any test results must be confirmed with another FDA-authorized test. These serological tests pose a unique regulatory situation. While they have not been reviewed by the FDA, they are technically “authorized” by the FDA under the special policy. Hence the companies selling these serological tests have been claiming in their marketing material that their tests have been “authorized” by the FDA. However, FDA now objects to the word “authorized”. In a statement released this week, FDA now prohibits the use of the word “authorized” or “approved” in the marketing material for serological diagnostics till they have a EUA approved by the FDA. FDA further prohibits the tests to claim that they can diagnose COVID-19. This seems to be contradictory to FDA’s original policy announcement from 16 March. In that policy FDA stated that these serological tests are simple and can be used to identify antibodies to coronavirus, the causative agent for COVID-19, in effect implying use of these tests to diagnose COVID-19. Now, it seems after FDA issued its first EUA for a serological test and with some other similar tests on the way to EUAs, FDA decided to tone down the original policy, and push companies to file the EUA applications. In all fairness, things have been moving very fast for FDA. It has been only 3 weeks from the original policy. Per that policy, it was expected that the notifying companies would file EUA applications within 2 weeks. But several of these suppliers purchased these tests from overseas, mostly from China, with an intent to make a quick buck and no intend to file an EUA. So, for FDA to push for the EUA, three weeks into its policy seems like a reasonable thing to do. Yes, there would be a backlash towards FDA from the consumers who have already purchase the serological tests thinking that they are buying FDA-authorized tests. There would also be a backlash from the suppliers since these tests were actually authorized by FDA, as described above. In these times of panic, FDA needs to be more measured in its statements to not create confusion. Instead of making a blanket statement about all tests and creating uncertainty, it would have been better for FDA to contact specific culprits to get them to correct their claims rather than create a broad chaos among consumers who are already not sure who to believe. |
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