Devices

Thermo Fisher PMA for Lung Cancer Assay

Thermo Fisher Scientific today has submitted the final module of a PMA for its Oncomine Universal Dx Test, a multi-gene, next-generation sequencing-based assay for non-small cell lung cancer (NSCLC). “If approved, the universal gene panel could be the first of its kind in the United States, and would serve as a companion diagnostic (CDx) utilized to select patients for specific NSCLC therapies,” the company says. The test would also be accessible to global pharmaceutical companies for ongoing development of therapeutic drugs. The device is designed to simultaneously screen patient tumor samples for multiple gene variants with a single test — minimizing the need to perform numerous sequential tests that identify individual biomarkers one at a time.

“As pharmaceutical companies shift toward developing new targeted therapies as opposed to ‘one-size-fits-all’ drugs, there is a clear need to more efficiently stratify cancer patients and tailor their treatments to enable better health outcomes,” Thermo Fisher says. “A companion diagnostic of this kind holds the promise to make precision medicine a reality.”

The Dx test is part of Thermo Fisher’s previously announced long-term collaboration with Novartis and Pfizer aimed at driving a paradigm shift in the way cancer patients are selected for drug therapies and the speed at which new NSCLC drugs are developed and registered. “Thermo Fisher’s PMA submission includes clinical and analytical claims associated with NSCLC biomarkers, and comes after the successful completion of clinical trials using patient samples provided by Novartis and Pfizer,” the company 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