FDA Needs More Info To Gauge Safety Of Essure Sterilization Device
The agency also wrote in a letter Thursday that a health-care startup’s cancer detection kit, which would be sold directly to healthy individuals, is high-risk and could harm public health.
FDA Advisers Call For More Safety Data On 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)
Startup's Cancer Test For The Healthy May Harm Public, FDA Says
The Food and Drug Administration said Thursday that a health-care startup’s cancer detection kit sold to healthy individuals is high-risk, could harm public health, and hasn’t 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)