Devices

Panel Views Asked on Shield Colorectal Cancer Screen

Members of the FDA Molecular and Genetics Panel of the Medical Devices Advisory Panel will be asked to vote 5/23 on the safety and effectiveness of the Guardant Health Shield blood-based colorectal cancer screening test. An agency executive summary distributed in advance of the meeting says Shield is a “qualitative in vitro diagnostic test intended to detect colorectal cancer-derived alterations in cell-free DNA plasma isolated from the whole blood collected in the Guardant blood collection tubes for individuals at average risk of the disease, age 45 years and older.”

The summary says Shield’s performance has been established in a prospectively designed, blinded, cross-sectional study. Its programmatic sensitivity for non-inferiority or superiority as compared to other recommended screening methods for colorectal cancer has not been established, it says.

“The risk of the Guardant blood-based test for advanced adenomas is that the test will fail to detect a patient with advanced adenoma which can later become neoplastic, losing the opportunity to prevent or prolong the onset of colorectal cancer,” the summary says. “The benefit of the Guardant test is that it may increase compliance with colorectal cancer screening and detect earlier stage colorectal cancer, which may potentially cure the patient and also potentially prolong survival when treated.”

Panel members are asked to discuss the appropriate patient populations for the test and whether the clinical performance supports its use as a primary screening option or as more appropriate for specific populations, such as those who decline other screening tests.

The panel members will vote on whether there is reasonable assurance that Shield is safe and effective for its proposed indications for use and whether its benefits outweigh its risks for the proposed indications.

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