Devices

Opko De Novo Filing for Prostate Cancer Test

Opko Health has submitted a de novo request to FDA seeking regulatory clearance for the 4Kscore, a blood test for intended use by health care professionals to assess a patient’s risk of having aggressive prostate cancer after an abnormal prostate specific antigen test result, and before a decision is made to perform a biopsy. “In multiple prospective controlled clinical studies, the 4Kscore test has shown consistent high sensitivity and high predictive values to identify men at higher risk of aggressive prostate cancer and who will benefit from a prostate biopsy, while helping to avoid biopsies in men who are at low risk,” the company says.

The test comprises four biomarkers that the company says are the result of more than a decade of research by scientists in Europe and the U.S., including scientists from the University of Turku and Memorial Sloan Kettering Cancer Center. “Through extensive research and multiple prospective controlled clinical validation studies, including large long-term outcome studies, the 4Kscore test with its algorithm in place for the last several years, has been shown to stratify subjects into low- and high-risk groups for future prostate cancer metastasis and mortality,” Opko says.

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