Is the new multi-cancer early detection test worth the $949 cost?
Doctors, researchers and patient advocates are cautiously optimistic about the liquid biopsy test that screens for more than 50 types of cancers, however, 62% of people who got positive results in a Lancet study didn't have cancer.
Medical professionals are cautiously optimistic about a new blood test that can screen for more than 50 types of cancers and costs less than $1,000.
The Galleri liquid biopsy looks for a shared cancer signal in DNA shed by tumors in the bloodstream. More than 130,000 of the prescription-only tests have been sold since they became available in June 2021, according to the test maker Grail. Despite its growing popularity, however, some cancer experts are encouraging caution.
“If I feel good and I’m asymptomatic and I have minimal risk for cancer, do I need to get this/?” asked Dr. Lori Minasian, deputy director of the National Cancer Institute’s Division of Cancer Prevention. “Let’s wait and see. I don’t think there’s enough evidence right now.”
Although the test is commercially available, it has yet to receive approval from the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services. The test, which isn’t covered by most insurance plans, is meant to supplement, not replace, recommended cancer screenings, Grail said. Some concierge doctors are offering the test to their patients, along with other new, experimental health screenings.
No research yet shows that the current test will prevent cancer deaths, experts said, and there is a risk of false positive or negative results. In a recent Lancet study, 62% of the people who got a positive result didn’t have cancer. Getting a false positive can cause worry and lead to unnecessary and costly follow-up procedures. False negatives, which are more likely for a test such as Galleri, could lead patients to skip recommended screenings.
The company and the test’s proponents say the potential benefit of catching cancer earlier outweighs those concerns. The company believes making these tests available will increase cancer detection and improve public health. “We still lose 600,000 people a year due to cancer in the U.S., which really speaks to the unmet need and the urgency about this new technology,” Grail’s Dr. Eric Klein said.
The University of Illinois-Chicago is participating in a nationwide study of Galleri. Researchers will evaluate the performance and safety of the test at dozens of clinical sites across the United States.
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“Cancer cells are inherently fragile and constantly turning over,” said Dr. V.K. Gadi, deputy director of the center. “As part of that process, they spill their contents, including DNA, into the bloodstream. If we see this pattern, we may be able to say it’s associated with cancer and even specifically say where that cancer might be coming from in the body.”
Meanwhile, Illumina, the parent company of Grail, is embroiled in legal action. Billionaire Carl Icahn recently filed a class-action suit alleging that the company’s board broke the law when they voted to direct the company to move forward with its takeover of Grail.