Single Blood Test Can Detect 50 Types of Cancer In Early Stages
The blood test has yet to gain approval from the U.S. Food and Drug Administration (FDA), which has so far issued a Breakthrough Therapy Designation, but GRAIL has already signed a deal with the National Health Service (NHS) in the U.K. to support programs that hope to detect cancer early and save more lives.
Despite the absence of the FDA's seal, the New York State Department of Health also issued a go-ahead to use Galleri for early cancer detection in September. The test is now available to residents by prescription, in addition to existing single cancer screening tests.
"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," commented Dr. Josh Ofman, chief medical officer and head of external affairs at GRAIL, in a statement.
Some 12 types of cancer dominate 75% of cancer cases in the United States. However, before Galleri, only five common screening tests were available for early detection, including colon, lung, cervical, prostate, and breast cancer. GRAIL's design includes the early detection of cancers that are typically difficult to identify, such as esophageal, neck, ovarian, pancreatic, and bladder cancers.
In early March, GRAIL entered into a partnership with Providence to use Galleri at its California, Oregon, and Washington points of care. The goal was to make the test available across all its operations in seven states, covering 50 hospitals and almost 1,100 health clinics serving five million patients.
"When combined with the power of our genomics research, having a single blood test that can detect more than 50 cancers advances our goal of finding cancer early, enabling our providers to administer treatment when it’s most likely to be successful and giving our patients the opportunity to achieve the best possible outcomes," commented Providence chief clinical officer Amy Compton-Phillips, M.D., in another press release.
Fast forward to the present, GRAIL, acquired by Illumina in September, is still working on its clinical trial to support its FDA application. The company already has over 130,000 participants who are willing to join, and there's a possibility that 150,000 more will be added before the year ends.
The Galleri test is recommended for adults with a high risk for cancer, including those aged 50 years and up. It is also designed to supplement and not replace other cancer screening tests.