Grail Inc. said Friday it has started U.S. sales of a blood test that can detect about 50 types of cancer.
The new Galleri test sells for $949, and collecting and processing the blood sample should take about 12 days, Grail says.
Grail says the test can screen blood for "cell-free nucleic acids," or fragments of DNA or RNA, cast off by the kinds of cells that cause many cases of bladder cancer, breast cancer, gallbladder cancer, lung cancer, ovarian cancer, pancreatic cancer, sarcoma and other forms of cancer.
In many cases, the Galleri test detects apparent cancer gene fragments when cancers are at an easy-to-treat, Stage 1 or Stage 2 level of severity, Grail says.
Grail emphasizes that doctors must investigate any worrisome gene fragments that the Galleri test detects to make a cancer diagnosis .
Early results from a study involving 6,629 people ages 50 and older showed that the Galleri test detected 29 cases of cancer, gave positive results for 36 people who seem not to have cancer, and gave positive results for 27 who are still going through diagnostic procedures, Grail says.
The validation study results collected so far suggest that the Galleri test could reduce 5-year cancer mortality by about 40% and prevent about 100,000 deaths per year, according to Francis deSouza, the CEO of a bigger biotech company, Illumina Inc. of San Diego.
Grail is offering the test by prescription only, and it's recommending that the patients who get the test be adults who appear to be at high risk of developing hard-to-detect cancers. The company says its test should complement existing cancer screening tests, not replace those tests.
Illumina carved Grail out from its own operations in 2016 and turned it into a separate company. Grail has become a Menlo Park, California-based company with a group of supporters that includes Jeff Bezos, the CEO of Amazon.com Inc.
Grail began the process of selling stock to the public in the fall, and Illumina then announced that it wants to buy out Grail's other investors and take full ownership of the company for $8 billion.
Insurance Implications
Today, Grail's references to insurance focus mainly on concerns about whether Medicare, Medicaid and private insurers will help consumers pay for the test.
