New Test Says It Can Find Cancer, for $949.

"Doctors, researchers and patient advocates are excited about a new blood test that promises to detect cancer early. They disagree about whether you should actually use it yet.

The $949 Galleri liquid biopsy can screen for more than 50 types of cancers. It works by looking 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 Galleri became available in June 2021, according to the test maker Grail, a unit of the gene-sequencing company Illumina.

The Galleri test is one of many products tapping into affluent and health-obsessed consumers' appetite for data on their personal health. Some longevity and concierge doctors are offering the test alongside other new, experimental health screenings including full-body MRI and biological-age testing.

Despite the rise in sales and backing from some doctors, others in medicine are preaching caution. They say there is no research that shows the current test will prevent cancer deaths and warn about the risk of getting false positive or negative results. 

In one study, more than half 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.

"If I feel good and I'm asymptomatic and I have minimal risk for cancer, do I need to get this?" says 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."

The company and the test's proponents say the potential benefit of catching cancer earlier outweighs those concerns. The company says it believes making these tests available will increase cancer detection and improve public health. If you get a positive test result, the company says it isn't a diagnosis and you should conduct an evaluation with a healthcare provider.

"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," says Dr. Eric Klein, distinguished scientist at Grail.

Valerie Caro, a real-estate broker in Flagstaff, Ariz., first learned about the test in a book by motivational speaker and life coach Tony Robbins. She was curious enough to ask a doctor about it despite having no symptoms. Two practitioners declined to prescribe it before she got a prescription through Grail's telehealth service in summer 2022.

The test flagged a possible cancer signal in her gallbladder or pancreas, and after several follow-up procedures including an MRI and gallbladder-removal surgery, she learned that a stage-two 4.3-cm cancerous tumor was nestled in her gallbladder. A year later, she says, she credits the test with saving her life.

"That's what happens when you catch it early," says Caro, 55.

Galleri is one of few commercially available tests known as multicancer early detection, or MCED. None are Food and Drug Administration-approved or recommended by the U.S. Preventive Services Task Force. The American Academy of Family Physicians says it recommends against mass screenings that aren't evidence-based, including routine use of MCED tests. The test, which isn't covered by most insurance plans, is meant to supplement, not replace, recommended cancer screenings, Grail says.

At the longevity physician Dr. Neil Paulvin's independent practice, the Galleri test is included as part of a comprehensive physical-exam package that can run from $5,000 up to $20,000, he says. Roughly half of his patients bring up the test with him. About 10% of them have taken it, he estimates.

Grail recommends the test for people with an elevated risk of cancer, such as those who are over the age of 50 or who have genetic risk factors.

The Galleri test returned a false positive in less than 1% of all people screened, according to the final results of a company-funded study recently published in the journal The Lancet. Among people who got positive results, 62% of them didn't have cancer. Grail says it is working to improve the test's positive predictive value, or the probability a person with a positive result has cancer, in future versions.

The NCI plans to begin a study in 2024 assessing whether MCED tests given to healthy patients can reduce cancer-related deaths. Grail won't participate in that study, a company spokesperson says.

Dr. LaTasha Seliby Perkins, a family-medicine doctor at MedStar Georgetown University Hospital in Washington, D.C., says she hasn't offered the test because of concern about the lack of FDA approval and because it is simply too expensive. "For folks who are just trying to make sure their needs are met, it is going to be a hard sell to say, 'Can you spend $1,000 on this test that we're not sure of its efficacy?'

Grail says it is working with several insurers to offer coverage." [1]

1. New Test Says It Can Find Cancer, for $949. Janin, Alex.  Wall Street Journal, Eastern edition; New York, N.Y.. 26 Oct 2023: A.11.