A startup which claims to offer a blood test that detects cancer before symptoms appear has been slapped down by America’s drug watchdog.
It says there is no evidence at all that it works, and warns that the “high risk” test may actually harm public health.
For example, someone could wrongly be diagnosed with cancer and attempt to undergo unnecessary surgery.
In a letter to Pathway Genomics’ chief executive Jim Plante, the US Food and Drug Administration (FDA) wrote: “We have examined published literature and have not found any published evidence that this test or any similar test has been clinically validated as a screening tool for early detection of cancer in high risk individuals.
“We believe you are offering a high-risk test that has not received adequate clinical validation and may harm the public health.”
Pathway Genomics is selling the test – called CancerIntercept – for $699 (£450) and claims it detects cancer cell DNA.
It is marketed as an early warning system for people who are at high risk of developing cancer but don’t have any symptoms.
Pathway has responded to the FDA’s letter, saying it “greatly respects and shares the FDA’s concerns about patient safety”.
It added that it has “performed appropriate validation of the test as a laboratory developed test, and we are in the process of performing additional studies”.
The FDA plans to meet with Pathway to find out what steps it took to validate the test.