John Hancock to Pilot 50-Cancer Detection Test

The U.S. Food and Drug Administration has given the Grail test a breakthrough device designation, and Grail is in the process of seeking FDA approval.

Grail itself has a clinical laboratory certified under the Clinical Laboratory Improvement Amendments  of 1988 standards, and it's presenting the Galleri test as a "laboratory-developed test" aimed at people ages 50 or older, or who are believed to have an elevated risk of cancer for other reasons.

Patients need a prescription from a health care provider to get the test, and Grail emphasizes that a positive result simply suggests that a patient may need to go through a diagnostic process, and that the test itself does not diagnose cancer.

One common concern about any new cancer screening test is that the test might end up detecting very small cancers that would never become serious enough to affect a patient's health, and that efforts to fight those very small cancers might be more dangerous to the patient than the cancers.

Grail says clinical trials show that the test has a low "false positive" rate and that 92% of the participants who had a true positive result said they were satisfied with the test.

Grail says it found that, in the small number of cases in a Galleri test that involved false positive results, only about 30% of the participants with false positive results had invasive diagnostic procedures; none of the diagnostic procedures led to adverse events; and some of the participants who did undergo invasive testing did so for reasons not related to the Galleri test results.

Other Insurers

Point32Health, the health plan formed from the combination of Tufts Health Plan and Harvard Pilgrim Health Care, announced plans in February to cover the Grail test through a pilot program and see what happens.

Another health insurer, Fountain Health, announced in August that it's adding Grail test benefits to its preventive services benefits package and paying 100% of the cost of the test.

Correction: An earlier version of this article gave an incorrect description of the status of Grail's efforts to seek approval for the Galleri test from the FDA. The FDA has given the test breakthrough device designation. Grail is still pursuing FDA approval for the test.

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