Devices

FDA Seeks Advisory Panel Input on Galleri Cancer Screening Test

FDA is seeking advisory committee input on 9/23 on the benefits and risks of GRAIL's Galleri multi-cancer early detection test after two pivotal studies showed that the blood-based screening test detected about one-third of cancers diagnosed within 12 months of testing. In an executive summary prepared for the agency’s Molecular and Clinical Genetics Panel meeting, device reviewers did not raise any red flags in the device submission, noting the test could offer an additional screening option, particularly for cancers that lack guideline-recommended screening methods.

Galleri uses next-generation sequencing to identify cancer-specific DNA methylation patterns in blood samples. The test reports whether a cancer signal is detected and, when positive, predicts the likely anatomical location of the cancer.

Among participants with cancer detected by Galleri, the test correctly predicted the cancer signal's anatomical origin in more than 90% of cases in both studies, according to the document. FDA noted that the potential benefits of multi-cancer screening include identifying cancers that might otherwise go undetected, particularly those without established screening options. However, false-positive results may expose patients to unnecessary diagnostic procedures and emotional distress, while false-negative results could delay diagnosis or create false reassurance.

The agency is asking the advisory panel to assess the clinical significance of Galleri's performance, including differences in sensitivity across cancer types, and whether additional warnings or other risk mitigations are warranted. FDA is also seeking recommendations on appropriate labeling and how the test's performance, benefits, risks and limitations should be communicated to healthcare providers and patients to support shared decision-making.

Galleri is intended to supplement, rather than replace, existing guideline-recommended cancer screening. A negative result does not rule out cancer, and a positive result requires additional diagnostic testing to confirm a cancer diagnosis, the agency noted.

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