Gilead's cancer blood test faces critical FDA review

A blood test designed to detect markers for several types of cancer in apparently healthy people faces its first major regulatory hurdle today, Wednesday, as U.S. government advisors review how well it works.

The test from the company Grail looks for DNA fragments shed by tumor cells, a novel screening technology aimed at detecting various cancers through a single blood draw.

Cancer screenings are intended to identify tumors at early stages when treatment is easier.

The multi-cancer screening test would represent a paradigm shift from the few cancer tests currently recommended—including mammography and colonoscopy—which each target a single type of cancer.

A panel of Food and Drug Administration (FDA) advisors will vote today, Wednesday, on whether the proposed benefits of the Galleri test, produced by Grail and designed for individuals aged 50 and older, outweigh risks such as missed cancer diagnoses or misleading results.

In documents released ahead of the meeting, FDA staff did not raise major safety concerns, but they want the committee to discuss whether the test detects enough cancers at early stages to justify marketing it for “early detection.”