Devices

Congress Should Pass VALID Act on LDTs: Advocates

Friends of Cancer Research CEO Jeff Allen and American Cancer Society Action Network president Lisa Lacasse say Congress should pass the VALID (Verifying Accurate Leading-edge IVCT Development) Act to “set a clear, modernized regulatory framework to ensure that any test, no matter where it is developed, meets the same quality and performance standards.” Writing in a Stat News online post, Allen and Lacasse say the bipartisan bill allows for continued innovation by providing detailed flexibilities that will ensure labs can still meet individual patient needs without delaying patient care.

The two say the ongoing development of precision medicine to treat cancers emphasizes the need for accurate diagnostic tests. “Oversight of such tests has not kept pace with innovation,” they write.

According to the post, FDA currently regulates and ensures only the accuracy of tests used in multiple laboratories or healthcare facilities. Those designed for only a single laboratory, known as laboratory-developed tests (LDTs), are left to meet less stringent standards, the writers say. “That means,” they say, “a growing number of lab tests, including those used to determine cancer treatment for a specific patient, are offered without assurances that they work.”

The post cites a study published in the American Journal of Clinical Pathology which reported that LDTs offered for the same intended use as an FDA-approved test had significant variability in their results. “Errors in tests, including false negatives (when the test inaccurately states the genetic marker is not present), may impede patients’ access to safe and effective treatments for their cancers,” the authors say.

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