Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Needs More Info To Gauge Safety Of Essure Sterilization Device
The Food and Drug Administration should gather more information to try to get a better sense of the safety of the Essure sterilization device, a panel of experts assembled by the agency recommended Thursday. (Stein, 9/24)
The Food and Drug Administration said Thursday that a health-care startup鈥檚 cancer detection kit sold to healthy individuals is high-risk, could harm public health, and hasn鈥檛 been validated by science. The FDA wrote to Pathway Genomics Corp. on Sept. 21 about the test, which retails for as much as $699. Patients get the test ordered by their doctor or one working for Pathway, then the company analyzes a blood sample for circulating traces of cancer. The company, which is backed by IBM Corp. and the venture capital firm Founders Fund, has touted the test as a less-expensive, faster way of detecting tumors. (Edney and Chen, 9/24)
