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New Blood Test Detects More Than 50 Types of Cancer

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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.

Grail says it will work on marketing the Galleri test to large, self-insured employer health plans, executive health programs and cash-only medical practices while it’s persuading the health insurance giants to pay for the test.

Medical experts at Reinsurance Group of America Inc., a life and health reinsurer based in Chesterfield, Missouri, talked about the life insurance underwriting implications of the technology Grail is using in an article published in 2018.

One challenge will be determining whether detecting the kinds of cancers the Galleri detects early on really has a significant effect on how long people live, the RGA medical experts said.

Widespread use of liquid biopsies could eventually lead to changes in the design and pricing of cancer insurance and other products that cover people with cancer, such as critical illness insurance, the RGA medical experts predicted.

Insurers will have to deal both with the risk that people who know they have cancer will rush out to buy cancer insurance and with the risk that liquid biopsies will detect too many minor cases of cancer, or too many cancer-like fragments of DNA that turn out to have nothing to do with cancer, the RGA executives wrote.

Impact Uncertainty

In theory, the Galleri test should improve people’s life expectancy, by helping doctors treat cancer early.

In the real world, however, the test could have a neutral or negative effect on people’s life expectancy. Positive tests could lead to aggressive treatment of early-stage cancers that would not have caused serious health problems, and the additional medical procedures could kill some patients. It’s also possible that the kinds of cancers that go on to kill people are difficult to control even when detected early on.

Grail has organized a study that will track about 35,000 U.S. patients who receive the Galleri test, to see how use of the test correlates with ups and downs in the patients’ well-being.

Grail is also organizing a large Galleri test in the United Kingdom. There, the National Health System will offer the test to 140,000 people ages 50 and older with no suspicions of cancer and to 25,000 people ages 40 and older who have suspicious signs or symptoms of cancer.

(Image: PopTika/Shutterstock)