FTC Slows Serendipitously Discovered Blood Test That Detects 50 Types of Cancer

(p. A13) Scientific breakthroughs are sometimes a matter of serendipity. Eight years ago Meredith Halks-Miller, a pathologist at the genetic-screening company Illumina, stumbled on something unusual while running prenatal blood tests for fetal chromosomal abnormalities. In some blood samples, the fetal genes were normal but the maternal DNA wasn’t. Illumina alerted pregnant women’s doctors to the finding. After further investigation, all the women were diagnosed with cancer, though none had symptoms when their blood was drawn.

This discovery led to the development of a blood test that can now detect 50 types of cancer and has the potential to save tens of thousands of lives a year if it becomes widely available. But regulators may slow the process.

The Federal Trade Commission last month wrapped up an administrative trial in which it seeks to block Illumina’s $8 billion acquisition of Grail, which makes the blood test.

. . .

Grail projects its test could prevent 90,000 to 100,000 cancer deaths each year if it were administered annually to all Americans 50 to 79. The sooner people get access to the test, the more lives will be saved. Illumina estimates that 10,000 lives will be saved over the following nine years for every year that it accelerates bringing the test to market. “By accelerating the global rollout of the test in the European Union, into Africa, into Asia, into Latin America, we believe we can save a lot more lives than that around the world,” Mr. deSouza says.

The company’s dominance in the DNA-testing market, however, attracted regulatory scrutiny. In March the FTC sued Illumina and Grail to block the acquisition, arguing that it would “lessen competition in the U.S. multi-cancer early detection (‘MCED’) test market by diminishing innovation and potentially increasing prices.”

Nonsense, Mr. deSouza says. “Today, there is nobody who is even starting the studies to develop a 50-cancer test like Grail, and once you start the study, it’s still a few years before you actually get the test. We think there will also be blood tests for single cancers, for colorectal cancer and other cancers. Those won’t compete with Grail. They will be complementary to Grail.”

For the full interview, see:

Allysia Finley, interviewer. “THE WEEKEND INTERVIEW; Regulatory Hurdles Block a Cancer Miracle.” The Wall Street Journal (Saturday, Oct. 9, 2021): A13.

(Note: ellipsis added.)

(Note: the online version of the interview has the date October 8, 2021, and has the same title as the print version.)

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