Devices

FDA Authorizes Cancer Tumor Profiling Test

FDA has authorized Memorial Sloan Kettering Cancer Center’s IMPACT (integrated mutation profiling of actionable cancer targets) tumor profiling test, an in vitro diagnostic assay that can identify a higher number of biomarkers than may be found in various cancers with any test previously reviewed by the agency. IMPACT was reviewed through the de novo premarket review pathway that is available for some low- to moderate-risk devices that are novel and for which there is no predicate device. An agency news release says its ability to detect genetic mutations was evaluated for precision, accuracy, and limit of detection. Results indicated that the assay is highly accurate (greater than 99%) and capable of detecting a mutation at a frequency range of 2-5%.

The IMPACT test uses next generation sequencing (NGS) to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a person’s tumor.

FDA says the authorization advances a policy framework that paves the way for efficient review and availability of other NGS-based cancer profiling tools.

Also, the agency says, the New York State Department of Health has been accredited as an FDA third-party reviewer of in vitro diagnostics, including tests similar to the IMPACT assay. In the future, it says, laboratories whose NGS-based tumor profiling tests have been approved by that state agency will not need to submit a separate 510(k) application to FDA. FDA says that other third-party reviewers also may become eligible to conduct such reviews and make clearance recommendations.

With its marketing authorization for the IMPACT test, FDA says, it is establishing a Class 2 regulatory pathway for the review of other NGS-based tumor profiling tests for use in patients diagnosed with cancer. The Class 2 designation allows such tests to be eligible to use FDA’s 510(k) clearance process, either by submitting an application directly to the agency or by going through an accredited third-party reviewer such as the New York State Health Department.

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