Devices

Panel Backs Shield Colon Cancer Test

Members of the FDA Molecular and Genetics Panel of the Medical Devices Advisory Panel have recommended the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. “The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk,” the company said after the vote.

“Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods,” the company says. “Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths.”

Panel members voted 8 to 1 that there is reasonable assurance Shield is safe, 6 to 3 that there is reasonable assurance Shield is effective, and 7 to 2 that the benefits of Shield outweigh its risks.

The PMA is based on data from the ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study showed that Shield “demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia,” the company says. “This performance is within range of existing stool-based tests used as primary CRC screening options, in which overall sensitivity ranges from 67% to 92%.”

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