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Grail Gets NY State Department of Health Approval for Galleri Multicancer Test

NEW YORK — Grail said on Monday that its Galleri blood-based multicancer early detection test has been approved by the New York State Department of Health.

With the approval, the test may now be offered by prescription in New York state as a complement to existing single-cancer screening tests, the Menlo Park, California-based company said.

"This approval represents a significant milestone in bringing Galleri to patients and healthcare providers across the US, and continued progress toward our mission to detect cancer early, when it can be cured," Josh Ofman, Grail's chief medical officer, said in a statement.

Galleri is designed to detect more than 50 cancer types through a routine blood draw and, when a cancer signal is detected, predict its origin. Grail launched the test in June in conjunction with the release of initial efficacy data from an ongoing prospective interventional study of the test.

Shortly thereafter, Grail was acquired by Illumina, which spun the company out in 2016, in a transaction that remains under scrutiny by the US Federal Trade Commission, as well as European regulators.

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