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FDA Panel Backs Blood Test That Detects Over 50 Cancers

A US government panel has backed a blood test that can detect more than 50 cancers. The Galleri test, made by GRAIL, could change how cancer is found.

An FDA advisory panel voted on September 23. Members voted 6 to 4 that the test is effective, and 7 to 2 that its benefits outweigh its risks. All 10 members agreed it is safe.

The panel’s vote is not binding. The FDA will make a final decision in the coming months. The test has been sold since 2021 as a lab-developed test for about 949 dollars.

Galleri looks for DNA shed by tumours in the blood. It is designed for adults aged 50 and over. It is not meant to replace standard screenings like mammograms or colonoscopies.

Some experts urge caution. A large British trial of 142,000 people did not find that the test cut late-stage cancer diagnoses. The National Cancer Institute’s Phil Castle told the panel the data was too early to prove clinical benefit.

GRAIL says the test finds cancers with no current screening options. The company hopes FDA approval will bring it to millions more people.

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