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Medtech in a Minute: Thermo Fisher’s COVID-19 Test Scrutinized, and More

Accuracy of Thermo Fisher’s TaqPath COVID-19 Combo Kit Questioned

FDA alerted clinical laboratory staff and healthcare providers of a risk of false results with Thermo Fisher Scientific’s TaqPath COVID-19 Combo Kit based on two issues related to the test kit and the associated Applied Biosystems COVID-19 Interpretive Software. The agency said the first issue is specifically related to inadequate vortexing and centrifugation of RT-PCR reaction plates. Thermo Fisher said it has updated its instructions to reduce the risk of inaccurate results. FDA said the second issue is related to the assay internal positive control and requires laboratory staff to upgrade their software to reduce the risk of invalid, potential false negatives, or inconclusive tests and to decrease the potential need to retest.

Trump Administration Nixes FDA Oversight of Lab-Developed Tests

Laboratory-developed tests will no longer be regulated by FDA, based on a new policy from the Trump administration. This has tremendous implications for laboratory-developed COVID-19 tests. The move occured as FDA put a potential pause on an emergency use authorization for convalescent plasma — a therapy President Trump has championed — to treat COVID-19.

Bayer Settles Thousands of Essure Lawsuits

Bayer said it has reached agreements to resolve roughly 90% of the nearly 39,000 total filed and unfiled U.S. Essure claims involving women who say they sustained device-related injuries after receiving the birth control implant. Bayer stopped selling Essure in the United States at the end of 2018, citing a decline in U.S. sales of the device and the conclusion that the Essure business was no longer sustainable. Despite the thousands of adverse event reports and patient lawsuits related to the product, the company insisted that its decision to discontinue Essure was purely a business decision and not out of concern for the safety or efficacy of the device. The company will pay nearly $1.6 billion to resolve these claims, including an allowance for outstanding claims, and is in resolution discussions with counsel for the remaining plaintiffs.

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