Data from GRAIL, a cancer early screening company owned by global gene sequencing giant Illumina, shows that its multi-cancer screening product "Galleri" has sold more than 130,000 orders, and has received an enthusiastic response especially among wealthier and health-obsessed people.

It is understood that Galleri claims to be the first blood-based multi-cancer early detection (MCED) product that has been clinically validated in the screening population and can detect more than 50 cancer types, of which more than 45 cancers have no effective detection methods. The product will be available in June 2021 and is currently priced at $949 per serving.


Source: Galleri

It should be noted that the U.S. Food and Drug Administration (FDA) granted "Breakthrough Device" designation in 2019, but has not yet given formal approval to this product. In fact, the FDA has never approved any MCED test to date.

Since Galleri requires a doctor's prescription, the sales situation can reflect that it has been recognized by some doctors, but the medical community as a whole is still cautious. Lori Minasian, deputy director of the Division of Cancer Prevention at the National Cancer Institute, said, "We'll wait and see. There's not enough evidence yet."

At the 2023 American Society of Clinical Oncology Annual Meeting (ASCO), Brian Nicholson, an oncologist at the University of Oxford in the United Kingdom, gave an oral report on the results of Galleri's clinical application. The results showed that the positive predictive value was approximately 75.5%, the negative predictive value was approximately 97.6%, the overall sensitivity was 66.3%, and the specificity was 98.4%.


Source: ASCO

A positive predictive value of 75.5% means that about three-quarters of those who test positive actually have cancer, and the other quarter are "false positives." Some believe that false positive results raise concerns and lead to unnecessary and expensive follow-up procedures.

GRAIL said the company is working to improve the positive predictive value in future versions. Some supporters also believe that Galleri's advantages in detecting cancer early outweigh these potential concerns. The official website also writes, "A positive test result is not a diagnosis and users should be evaluated with a health care provider."

However, the American Academy of Family Physicians recommends against such mass screening, including other MCED tests, without evidence. Doctor LaTasha Seliby Perkins said she does not offer the Galleri test to patients because it is not FDA-approved and the test is too expensive for patients.

Grail responded that Galleri is intended to supplement, not replace, recommended cancer screenings and that most insurance plans do not cover the test. Retired nurse Laura Miller said her two brothers suffered from different types of cancer. "If I had cancer, I would want to be the first to know the results."