Devices

2 New Genetic Disease-Based Test Guidances

FDA has finalized two guidances intended to drive development of next generation sequencing (NGS) that scans an individual’s DNA to diagnose genetic diseases and guide medical treatment. An agency statement (includes links to the guidances) says the documents provide recommendations for designing, developing, and validating tests that use NGS.

“As disease detection technologies rapidly evolve,” says FDA commissioner Scott Gottlieb, “so must FDA’s approach to reviewing these new innovations. The new policies issued today provide a modern and flexible framework to generate data needed to support FDA’s review of NGS-based tests, and give developers new tools to support the efficient development and validation of these technologies.”

The first guidance, Use of Public Health Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics, describes an approach through which test developers may rely on clinical evidence from FDA-recognized public databases to support clinical claims for their tests and help provide assurance of the accurate clinical evaluation of genomic test results. “Using FDA-recognized databases will provide test developers with an efficient path for marketing clearance or approval of a new test,” the statement says.

The second guidance, Consideration for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases, describes what the agency would look for in premarket submissions to determine a test’s analytical validity, including how well the test detects the presence or absence of a particular genomic change.

FDA says issuance of the final guidances was based on extensive feedback from the public and stakeholders who are developing NGS-based technologies.

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

Read more

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