Devices

FDA Alert on False Negatives on Abbott Covid Test

FDA has issued an alert about preliminary data from New York University researchers suggesting potential inaccurate results (false negatives) from Abbott’s ID NOW point-of-care test used to diagnose Covid-19. Abbott’s test is frequently used at the White House to test visitors before entering the Oval Office. A draft journal article on the false negatives was posted online, and FDA says it is reviewing the article (see earlier story), which has not been peer-reviewed.

“We will continue to study the data available and are working with the company to create additional mechanisms for studying the test,” the FDA alert says. “This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” adds CDRH Office of In Vitro Diagnostics and Radiological Health director Tim Stenzel.

The agency says it is aware of some scientific studies that have identified accuracy issues with the test and it is investigating whether it could be due to the types of swabs used or the type of viral transport media (material used to transport the specimen). “While there is important information to gather from these studies, it should be noted these studies have limitations, including small sample size, potential design biases, or tests that may not have been executed according to the manufacturer's instructions for use, an important part of scientific research,” it says.

FDA also says it has received 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results. Abbott has agreed to conduct post-market studies for the device that each will include at least 150 Covid-19 positive patients in a variety of clinical settings, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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