A blood test designed to screen for signs of more than 50 types of cancer has moved a step closer to receiving approval from the U.S. Food and Drug Administration.

The test, called Galleri, is made by GRAIL and uses a standard blood sample to look for patterns in DNA that may indicate cancer is present. When a cancer signal is detected, the test is also designed to identify where in the body that signal most likely originated, which can help doctors determine what additional testing may be needed.

An independent FDA advisory committee reviewed the test Wednesday, Sept. 23, and voted in favor of its approval. The panel voted 7-2, with one member abstaining, that the benefits of the test outweigh its risks. Members also voted 10-0 that the test is safe and 6-4 that it is effective.

The committee’s recommendation does not mean Galleri has received FDA approval. The FDA will make the final decision after considering the committee’s recommendation and the information submitted by the company.

Galleri is intended for adults age 50 and older who do not have signs or symptoms of cancer. The test is already commercially available in the United States as a laboratory-developed test, but it has not received formal FDA approval.

The test is not intended to replace traditional cancer screenings. Patients would still need to follow recommendations for mammograms, colonoscopies and other routine screenings. A negative Galleri result does not guarantee that a person is cancer-free, and a positive result does not mean a person has been diagnosed with cancer. Additional testing is required to confirm whether cancer is present.

The technology has generated interest because many types of cancer currently have no routine screening test. A blood test that can identify signals from many cancers could help doctors find some cancers before symptoms appear.

The FDA has not announced a final decision on Galleri.

---