On September 20, 2021 GRAIL, LLC, a healthcare company whose mission is to detect cancer early, reported that the New York State Department of Health (NYSDOH) has approved Galleri, GRAIL’s groundbreaking multi-cancer early detection blood test (Press release, Grail, SEP 20, 2021, View Source [SID1234588028]). With NYSDOH approval, Galleri is now available to residents in the state of New York by prescription to complement existing single cancer screening tests.
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The standard set by New York State represents one of the most rigorous levels of validation required for laboratory developed tests. Clinical laboratories conducting testing on specimens from New York residents also must obtain a clinical laboratory permit. The permit of a clinical laboratory helps ensure the accuracy and reliability of clinical tests.
"We are pleased that healthcare providers in New York can now prescribe Galleri, a first-of-kind blood test that can detect multiple cancers early, when treatment is more likely to be successful," said Dr. Josh Ofman, chief medical officer and head of external affairs at GRAIL. "The approval of the New York State Department of Health marks a significant regulatory milestone for GRAIL and confirms the high standard for validation of our rigorous approach to test development, and the high quality of our clinical laboratory. Most importantly, this approval represents a significant milestone in bringing Galleri to patients and healthcare providers across the U.S., and continued progress toward our mission to detect cancer early, when it can be cured."
The GRAIL laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP). Widely recognized as a gold standard for clinical laboratory accreditations, the CAP Laboratory Accreditation Program is designed to ensure laboratories meet stringent requirements and standards of quality, safety, and accuracy.
More than 600,000 people died from cancer last year in the U.S., according to the American Cancer Society. This is in large part because the majority of cancers are found too late when outcomes are often poor. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and in high-risk smokers, lung. In fact, 71% of cancer deaths have no recommended early detection screening at all.
About Galleri
The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect more than 50 types of cancer through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.