Devices

Mainz Seeks Breakthrough Status for Colon Cancer Test

Mainz Biomed has submitted an application requesting a breakthrough device designation for what it calls its non-invasive next-generation colorectal cancer test including the company’s portfolio of messenger (mRNA) biomarkers. The submission is based on data read-outs of its clinical studies ColoFuture and eAArly Detect, as well as data from a pooled study. Based on these studies, Mainz Biomed says it has now “defined the final configuration of its next-generation test integrating the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and machine learning algorithm that the company plans to use in its next generation product, and the FDA premarket approval study.”

The data analysis involved 295 clinical subjects from 21 specialized gastroenterology centers across the U.S., showing “precise differentiation among colorectal cancer, advanced adenomas, non-advanced adenomas, and samples with no pathological findings,” the company says. Key findings were:

Sensitivity for colorectal cancer: 97%
Sensitivity for advanced precancerous lesions: 88%
Specificity: 93%

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