Devices

Cancer Assay Gets Parallel Review at FDA/CMS

FDA and the Centers for Medicare and Medicaid Services (CMS) have accepted a Foundation Medicine PMA for FoundationOne for a “parallel review” in order to expedite reviews of the oncologic comprehensive genomic profiling assay. FDA also accepted the company’s request for review as part of its Expedited Access Pathway for breakthrough devices. “If approved, FoundationOne could be the first FDA-approved comprehensive genomic profiling (CGP) assay to incorporate multiple companion diagnostics (CDx) to support precision medicine in oncology, including an indication for use as a companion diagnostic across a diverse range of solid tumors,” the company says. “Importantly, obtaining a Medicare National Coverage Determination (NCD) from CMS concurrently with FDA approval will allow FoundationOne to be offered as a covered benefit under Medicare and avoid the significant time interval and uncertainty that often occurs between FDA approval and an NCD.” Foundation Medicine believes the parallel review will conclude in the second half of 2017.

The assay is designed to detect genomic alterations, including substitutions, insertions and deletions, copy number alterations and select gene rearrangements in 324 genes using DNA isolated from formalin-fixed paraffin-embedded tumor tissue specimens using next-generation sequencing and computational analysis, according to the company. If approved, the test will be used to identify patients who may benefit from treatment for solid tumor malignancies. It is also intended to provide treating physicians with important information, including cancer related variants and molecular signatures to inform molecular eligibility for clinical trials or treatment management according to clinical care guidelines.

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