A controversial, cancer-detecting blood test just got backed by key FDA panel

Meanwhile, a controversial, cancer-detecting blood test just obtained backed by key FDA panel.

Key points

• In October 2025, GRAIL presented findings from a study throughout 25, 000 healthy adults over the age of 50.
• The test – which costs $949 – studies DNA fragments shed into the bloodstream.
• The FDA is projected to produce a final decision on Galleri premarket approval in the coming months, the release continued.
• In the United States, only five cancers are widely screen for: breast, colorectal, prostate, cervical and lung cancer, the latter in only high-risk patients.
• "The key plain takeaway: (This type of testing) may complement current screening by identifying lethal cancers that are otherwise undetected earlier and with limited downstream burden, " Dr.

Meanwhile, a controversial, cancer-detecting blood test just obtained backed by key FDA panel. Sara Moniuszko, David Oliver USA TODAY. Breast cancer screening and early detection is key.

There are more ways than ever to know of the threat for breast cancer, including with genetic testing. Fox – 2 Detroit.

Meanwhile, a controversial blood test aimed at detecting multiple cancers was backed by a U.S. Food and Drug Administration panel this week.

On Wednesday, Sept. 23, the FDA's Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee confirmed a favorable vote for the technology, called the Galleri multi-cancer early detection (MCED) test.

GRAIL, the firm behind Galleri, stated the 10 voting members considered the test's "safety, effectiveness and overall benefit-risk profile for screening for the early detection of multiple types of cancer in adults aged 50 years and older, " according to a news release.

On whether the benefits of Galleri outweigh its risks, the committee voted seven to two with one abstention, six to four in backing of Galleri's effectiveness, and for safety, the vote was unanimously in backing.

Meanwhile, the FDA is projected to produce a final decision on Galleri premarket approval in the coming months, the release continued. While the FDA takes these votes into considerations, the agency is not bound by the committee's recommendations. Here's what to know regarding the test. What is Galleri and what does it do?

For context, the test – which costs $949 – studies DNA fragments shed into the bloodstream. Patients need a prescription before pulling up their sleeves.

In October 2025, GRAIL presented findings from a study throughout 25, 000 healthy adults over the age of 50. The test, the firm stated, discovered cancers at earlier stages and in organs that don't have routine screening. Galleri discovered cancer signals in 216 individuals, and 133 of them indeed had cancer. It additionally correctly predicted the cancer's origin 92% of the time.

"We're able to isolate those DNA fragments, sequence them and look for those tumor-specific markers from the blood, " Megan Hall, the vice president of medical and corporate affairs at GRAIL, previously informed USA TODAY. If a "cancer signal" is detected, it additionally provides a cancer signal origin prediction, or a clue to the providers and the patient which organ that signal could be coming from. If that origin was the pancreas, for example, doctors would know where to start looking for the feasible cancer. Why is it controversial?

In the United States, only five cancers are widely screen for: breast, colorectal, prostate, cervical and lung cancer, the latter in only high-risk patients. But 70% of cancer deaths come from those without a recommended screening test. That's where Galleri hopes to split the difference. But its efficacy has been called into question.

In practice, a major trial conducted with England's National Health Service did not show a significant reduction in late-stage cancer diagnoses for patients who took the Galleri test, the firm shared earlier this year.

"The key plain takeaway: (This type of testing) may complement current screening by identifying lethal cancers that are otherwise undetected earlier and with limited downstream burden, " Dr. Mohamed Abazeed, chair and professor of radiation oncology at Northwestern University. This person was not involved with the study, previously informed USA TODAY. 'A positive blood test is not a diagnosis'.

Beware additionally that Galleri does and can pick up indolent cancers – I.e. Slow-growing ones like Chronic lymphocytic leukemia – which you and your provider may decide not to treat, or just keep an eye on.

"We want to make sure that we are detecting those more aggressive cancers that really do warrant treatment, " notes Hall.

Overall, doctors both involved with and not involved with the study weren't concerned regarding the Galleri test and overdiagnosis, or sending residents down a path of unnecessary endless treatment. Regarding 1% of residents receive a positive cancer detection signal. It means 99% live their lives and go regarding their normal recommended screenings.

But "a positive blood test is not a diagnosis, " Dr. Gilberto Lopes, chief of medical oncology with University of Miami Health System's Sylvester Comprehensive Cancer Center, previously informed USA TODAY. "You still need imaging, sometimes a biopsy. That takes time and resources." Share your feedback to support improve our site!

In short, a controversial, cancer-detecting blood test just got backed by key FDA panel is the central thread here, and readers can expect follow-up reporting as the picture becomes clearer.