The FDA's Gastroenterology & Urology Devices panel came down firmly against EDAP's Ablatherm system for treating low-risk, localized prostate cancer. The panel voted 9-0 on the device's effectiveness, 5-3 against its safety (with one abstention) and said the risks outweigh the benefits by a vote of 8-0 (with one abstention).
French devicemaker EDAP TMS SA is facing FDA scrutiny for its robotic device for prostate cancer, as regulators questioned the product's safety and efficacy in a new report.
The cancer vaccine field has seen its share of late-stage disappointments and outright flops, but a number of hopefuls are lining up to present new research backing their experimental shots at this year's upcoming American Society of Clinical Oncology Annual Meeting in Chicago.
As Astellas Pharma and Medivation work to broaden the reach of their prostate cancer drug Xtandi, researchers have identified a biomarker that could help proactively spot patients for whom the treatment will not work.
MDxHealth will ally with a Texas-based provider network in a deal that will greatly expand the reach of its signature prostate cancer molecular diagnostic test to millions of additional patients.
New research supports the use of a circulating tumor cell blood test, rather than the standard PSA biomarker diagnostic, to predict a patient's odds of surviving prostate cancer.
A U.K. diagnostics startup is off and running, backed by nearly $21.3 million in financing to support development of a PET imaging agent for recurrent prostate cancer licensed from GE Healthcare.
Exosome Diagnostics announces this morning it has raised $27 million and will go to market in 2014 with its first fluid-based diagnostic test, a noninvasive urine sample designed to detect prostate cancer without a biopsy.
Myriad Genetics is celebrating promising results from a study demonstrating the clinical utility of its Prolaris prostate cancer molecular diagnostic test. The Utah company hopes to use the data to win Medicare reimbursement for the test by this June.
Myriad Genetics, long known for its predictive breast cancer tests, said recent clinical data backs up assertions that one of its new diagnostic assays can successfully determine which men will face a recurrence or spread of prostate cancer after radical surgery.