Devices

Grail Submits Final PMA Module for Cancer Blood Test

Grail has submitted the final module of its PMA for the company’s multi-cancer early detection blood test. The Galleri test, which was designated a Breakthrough Device by FDA in 2018, is designed to detect cancer signals and predict their tissue of origin from a single blood draw. It identifies DNA in the bloodstream shed by cancer cells and does not predict future genetic risk for cancer, the company says. If approved, it would be among the first multi-cancer screening tests authorized for use in asymptomatic individuals.

The PMA submission is based primarily on data from two large studies: the U.S.-based PATHFINDER 2 study and the NHS-Galleri trial conducted in England. According to Grail, the application includes test performance and safety data from 25,490 participants enrolled in PATHFINDER 2 with one year of follow-up, as well as results from the first screening round of the NHS-Galleri trial, the largest randomized controlled trial conducted to date for a multi-cancer early detection test.

The filing also includes a bridging analysis comparing the version of Galleri used in the clinical studies with the updated version submitted for FDA approval.

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