Devices

FDA Approves Cancer Biomarker Test

FDA has approved Foundation Medicine’s FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. An agency news release says that compared to other companion diagnostics previously approved by FDA, the F1CDx is a more extensive test that provides information on a number of different genetic mutations that may help in the clinical management of cancer patients. Also, based on individual test results, the new test reportedly can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options.

The release says the device works by sequencing DNA from a patient’s tumor sample to determine the presence of gene mutations and alterations. It also detects microsatellite instability and tumor mutation burden.

Clinical performance of the F1CDx was established through a least burdensome means, FDA says, by comparing it to previously approved companion diagnostic tests that are currently used to determine patient eligibility for certain treatments. Results reportedly indicated that the test’s ability to detect select mutation types representative of the entire 324 gene panel is accurate about 94.6% of the time.

Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a proposed national coverage determination for the test for Medicare beneficiaries with advanced cancer who have not been previously tested using the same next generation sequencing technology and seek further cancer therapy.

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