Drugs

Roche EUA for Cobas Coronavirus Test

FDA has issued Roche Molecular Systems an emergency use authorization (EUA) for its cobas SARS-CoV-2 test for diagnosing coronavirus (COVID-19). The EUA was granted within 24 hours after receiving the application from the company, an FDA release says. “To expedite access to this test, FDA did not object to Roche pre-positioning its test so that labs could be ready to initiate testing immediately upon authorization of the EUA, it says. “Because of that pre-positioning, laboratories can immediately run tests on Roche’s high-volume platform, which will greatly increase national testing capacity.”

Roche says the single-well dual target assay is intended to qualitatively detect nucleic acids from coronavirus in nasopharyngeal and oropharyngeal swab samples from patients who meet the government’s clinical criteria. The test runs on the cobas 6800/8800 systems and has a full-process negative control, positive control and internal control.

Meanwhile, FDA says it is using enforcement discretion and is not objecting to the New York State Department of Health (NYSDOH) authorizing certain laboratories in the state to begin patient testing after validating their tests and notifying the NYSDOH. “Under NYSDOH’s approach, laboratories will provide validation data to NYSDOH within 15 days in lieu of pursuing an EUA with FDA,” the agency says. This flexibility is based on the urgent public health need for additional testing capacity in New York, which is overwhelmed with the virus outbreak.

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