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A Blood Test That Screens for Dozens of Cancers May Be Near

TheTrendsWire Editorial
||5 min read
The FDA could approve the first blood test capable of screening for dozens of cancers by the end of the year, a shift that could reshape how cancer screening works.
The FDA could approve the first blood test capable of screening for dozens of cancers by the end of the year, a shift that could reshape how cancer screening works.

Right now, screening for cancer means a different test for every type.

A breast scan. A colonoscopy. A Pap smear. A separate exam for each one. That could be about to change.

What Makes This Test Different

The FDA could approve the first blood test capable of detecting multiple cancers around the end of this year, according to NPR, setting the stage for it to become widely available.

Currently, standard screening in the US covers just five cancers: breast, colon, cervical, prostate, and lung โ€” each requiring its own dedicated scan or exam.

By comparison, the leading test, called Galleri, can detect small amounts of cancer-related DNA or other markers for up to 50 different cancer types from a single vial of blood.

A second test, Cancerguard, made by Exact Sciences, works on a similar principle.

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What These Tests Actually Do โ€” and Don't Do

It's important to be precise about what this technology accomplishes.

These tests don't diagnose cancer outright. Instead, they flag early signals that tell doctors where to look more closely, directing follow-up scans or biopsies toward a specific area of concern rather than confirming a diagnosis on their own.

That distinction matters for how the technology should be understood: it's a triage tool that narrows where more investigation happens, not a replacement for the diagnostic process itself.

Both Galleri and Cancerguard are already available for purchase in the US under a special FDA designation, but full FDA approval โ€” the more rigorous process required for insurance and Medicare coverage โ€” has not yet been granted to either.

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Why Doctors Are Already Changing How They Think About Treatment

The underlying science behind these tests is already influencing clinical practice in other contexts.

UCLA lung cancer specialist Jonathan Goldman has already changed how he treats some patients based on similar blood-based technology, which can identify early signals of a cancer's presence or signs it's developing resistance to a current treatment.

That framing โ€” blood tests as an early-warning system for either a new cancer or a treatment that's stopped working โ€” represents a broader shift happening across oncology, not just in screening for healthy people but in monitoring patients already undergoing treatment.

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The Money Behind the Tests

Cost remains a real barrier, even with FDA approval potentially on the horizon.

Grail sets the retail price for the Galleri test at $950. Cancerguard's list price is $659.

It's not yet known how much either company would charge commercial insurers once full FDA approval is granted, since pricing for insurance reimbursement often differs from direct consumer retail pricing.

Congress has already taken a step toward broader access: as part of a spending package passed in February, lawmakers voted to allow Medicare to reimburse the cost of multi-cancer detection tests starting in 2028 โ€” a date that sits well beyond the FDA approval timeline currently being discussed.

The Research Still Underway

Large-scale studies are currently testing how well the Galleri test performs across real-world populations.

One study is tracking more than 142,000 patients over 50 through the UK's National Health Service.

A second study, called Pathfinder 2, involves 35,000 patients across North America.

Those population-level studies matter because a test's performance in a smaller initial trial doesn't always hold up the same way across a much larger, more diverse group of people โ€” which is part of why regulators are taking a more cautious, staged approach to full approval rather than fast-tracking the technology based on early results alone.

Key Takeaways

  • The FDA could approve the first multi-cancer detection blood test around the end of this year.
  • The leading test, Galleri, can screen for up to 50 cancer types from a single blood draw, compared to the 5 cancers currently covered by standard US screening.
  • These tests flag early signals for doctors to investigate further โ€” they do not diagnose cancer on their own.
  • Galleri costs $950 at retail; Cancerguard, made by Exact Sciences, costs $659.
  • Medicare is set to begin reimbursing multi-cancer detection tests starting in 2028.
  • Large studies, including one tracking 142,000+ patients through the UK's NHS, are evaluating real-world performance.

Sources

Also Read

Tags:multi-cancer blood testFDA approval cancer screeningGalleri test GrailCancerguard Exact SciencesMCED multi-cancer early detectioncancer screening single blood testMedicare cancer test coverage 2028Jonathan Goldman lung cancercancer DNA blood testGalleri test price 950Cancerguard test price 659FDA special designation cancer testcancer screening five types currentPathfinder 2 cancer studyNHS Galleri study UKmulticancer detection legislation Congresscancer biomarker blood testearly cancer detection technologycancer screening paradigm shiftliquid biopsy cancer test
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