The Miracle Cancer Test

 

Cancer may be the most frightening word in the English language. As a physician, I know that if I have to approach that word with my patients, I must be prepared for their frightened reaction. In fact, I am so careful to broach the subject of cancer with my patients that I am even careful when I tell them they don’t have cancer, lest they mistake what I’m saying to mean the opposite!

We all know detecting cancer early is very important to the prognosis. Many types of cancer are curable if detected early, such as breast, prostate, colon, kidney, and skin cancers. Unfortunately, many cancers are nearly always detected late when treatment is rarely curative, such as pancreatic, lung, and brain cancers.

Just imagine, what if you could take a simple blood test to detect 50 different types of cancer early enough to be cured? Sounds like a fantasy – but it isn’t. In fact, such a blood test has already been developed. But alas, it is stuck in regulatory purgatory and may take years to reach availability.

Regular readers of The Wall Street Journal know the Saturday edition always has a section called The Weekend Interview. This week Allysia Finley interviewed Francis deSouza, CEO of a company called Illumina. She tells us that eight years ago a scientific breakthrough occurred by serendipity. 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 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 currently, regulators are slowing down 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, the company that makes the blood test. Illumina founded Grail in 2015 and spun it off a year later. The Menlo Park, California -based startup is named Grail because scientists have long been on a quest for a blood test that can diagnose cancer early – the Holy Grail!

“We know that cancer kills about 10 million people a year – about 600,000 in the U.S. And we know that even for some of the deadliest cancers, your odds of survival are much higher if you catch the cancer in Stage 1 or Stage 2,” says Illumina CEO Francis deSouza. “So a blood test that can catch cancer early can truly be life-changing.”

Currently there are only recommended screenings for five cancers – breast, colon, prostate, cervical, and lung in high-risk smokers. While these tests can be very helpful, they are also prone to false positives – suggesting cancer that isn’t really there. Cancer is absent in about 70% of patients with an elevated PSA test for prostate cancer detection and 7 to 12% of suspicious mammograms. The Grail blood test has a false positive rate of less than 1%.

To be sure, the Grail blood test is not perfect. But it can detect the 12 deadliest cancers with 60% accuracy. But Grail estimates that adding the blood test to existing screening could reduce late-stage cancer diagnoses by more than half among patients ages 50 to 79, which translates into a 26% overall reduction in five-year cancer mortality.

Why, you might ask, did Illumina spin off Grail after the discovery of this blood test? After Dr. Halks-Miller’s discovery, more research, clinical testing and investment were needed before a test could launch to the public. Illumina spun off Grail so that it could raise more money for studies. Grail ultimately raised $1.9 billion in capital, while Illumina maintained a 12% stake. With a commercially viable product nearly in hand, Grail in September 2020 began exploring an initial public offering (IPO). That’s when Illumina made its $8 billion offer.

Why is the FTC holding up the Illumina acquisition of Grail?

Illumina is the leading manufacturer of gene-sequencing machines, were the first to identify the novel coronavirus in late 2019, and more than 70 countries are using them to find new variants. Moderna and Pfizer also relied on DNA sequencing from Illumina machines to develop their mRNA vaccines.

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 detecting test market by diminishing innovation and potentially increasing prices.” Mr. deSouza pushes back from this analysis, saying, “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.”

Illumina promised the FTC it wouldn’t thwart Grail’s potential competitors and would give its clinical oncology customers contractual guarantees of ‘equal and fair access.” But the FTC wasn’t satisfied. Although it asked the federal judge overseeing the case to dismiss its complaint in June, it’s still alive as an administrative proceeding. Frustrated by the slow process, Illumina and Grail closed the deal in August despite the risk that it could be undone if it loses in U.S. or European courts. As for the U.S., the Supreme Court likely wouldn’t hear a case until 2025, so Illumina faces the risk that the deal could be blocked for years.

It’s frustrating to imagine the number of lives lost by the delays before this breakthrough, exciting scientific development becomes a reality. But the future is nevertheless bright. Mr. deSouza says, “I truly believe that, within our lifetime, we can make a significant dent in cancer survival rates, and a lot of that will come through the work that’s done in genomics.”

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