Drugs

FDA Watching Serological Tests for False Claims

FDA says it is concerned about some firms falsely claiming that their serological tests are FDA approved/authorized or that they can diagnose Covid-19. In a 4/8 notice, the agency says it will take “appropriate action” against firms making such false claims or marketing tests that are not accurate and reliable.

Serological tests measure the amount of Covid-19 antibodies or proteins present in the blood when the body is responding to the infection. They will be heavily used to identify individuals who have overcome an infection in the past and have developed an immune response. Because of this, the tests are seeing extra FDA attention and were the subject of much discussion during a 4/8 CDRH virtual town hall teleconference on diagnostic tests (see earlier story).

FDA also notes that in the early days of a Covid-19 infection, the body’s immune response is still building and antibodies may not be detected. “This limits the test’s effectiveness for diagnosing Covid-19, and why it should not be used as the sole basis to diagnose Covid-19,” it says.

Last month, an agency guidance entitled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” outlined how serological tests can be marketed. This includes allowing developers to market their tests without prior FDA review if certain conditions outlined in the guidance are met. Serological tests can also be authorized under an Emergency Use Authorization (EUA). To date, FDA has approved one EUA for a serological test that is intended for use by clinical laboratories. So far, over 70 test developers have notified the agency that they have serological tests available for use, and these are some of the tests that FDA says may be making false claims.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome