Devices

Roche Cervical Cancer Biomarker Test Approved

FDA has approved a Roche PMA for its CINtec Plus Cytology as a biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas 4800 HPV Test. The test identifies those women whose HPV infections are most likely to be associated with cervical pre-cancers, the company says. It enables clinicians to determine which women should be referred to immediate further diagnostic procedures, helping to prevent women from developing more advanced cervical disease, it says. Approval was based on data from the Roche-sponsored registrational IMPACT (Improving Primary screening and Colposcopy Triage) trial, which enrolled more than 35,000 women in the U.S. to clinically validate the triage test in different screening scenarios.

The dual-stain biomarker technology included in the test detects the simultaneous presence within a single cell of the two biomarkers — p16 and Ki-67, according to the company. “A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease,” the company says. The test can be performed using the same liquid sample that is used for HPV or Pap cytology testing.

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