Drugs

Breakthrough Status for Cancer Detector

FDA has granted Geneseeq a breakthrough device designation for its multi-cancer early detection device, CanScan. The device uses “low-depth whole-genome sequencing” on circulating cell-free DNA (cfDNA) from a single peripheral blood draw to extract “genetic and fragmentomic features to detect early cancer signals with 99% specificity and predict the tissue of origin (TOO) of cancers to help guide next steps for cancer diagnosis,” the company says. “The test outperforms current standard of care (SOC) screening methods in common cancer types, such as prostate, lung and liver cancers. It also detects cancer types currently without effective SOC screening methods, such as esophagus, endometrial, gastric, pancreatic cancers and lymphoma.”

Geneseeq says the test’s s performance has been validated in a large-scale clinical study, DECIPHER (Detecting Early Cancer by Inspecting cfDNA Features), in over 13 cancer types. It is currently undergoing a “real-world evaluation” in the Jinling Cohort (NCT06011694), a large-scale prospective multi-center trial involving 15,000 patients, it adds. Results from the cohort is expected later this year.

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