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Startup's Cancer Test for the Healthy May Harm Public, FDA Says

  • Pathway uses blood sample to detect early cancer signs
  • FDA calls test unproven and seeks meeting with company
Updated on

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.