Devices

FDA OKs Breakthrough Colorectal Cancer Test

FDA has approved a Geneoscopy PMA for its colorectal cancer stool-based screening test ColoSense, indicated for adults aged 45 years and older who are at typical average risk for developing colorectal cancer (CRC). Designated as a breakthrough device earlier by FDA, the company says )the test is the “first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.”

Approval was based on data from the CRC-PREVENT trial that evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds, according to the company. “In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable,” it says. “Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable.”

Colorectal cancer is the second deadliest cancer in the U.S., Geneoscopy notes. A positive ColoSense result may indicate the presence of colorectal cancer, advanced adenomas, or serrated precancerous lesions and should be followed by a colonoscopy, it says.

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