GRAIL vs bioAffinity Technologies (2026)
Both are laboratory developed cancer tests that use machine learning, and they sit at opposite ends of the pathway. bioAffinity Technologies' CyPath Lung starts after a scan: for high risk patients with an indeterminate lung nodule, sputum collected at home is labeled and run on a flow cytometer, and an algorithm reports Likely or Unlikely with a probability score to the ordering physician. GRAIL's Galleri starts before anything is suspected. A blood draw is read for cell free DNA methylation signals across more than 50 cancer types, with a predicted site of origin, in addition to guideline screening. Its FDA application is pending, and the randomized NHS-Galleri trial did not meet its primary endpoint of fewer late stage cancers. CyPath Lung narrows one suspected cancer; Galleri casts a wide net in people with no symptoms.
- A test for patients who already have an indeterminate lung nodule.
- Sputum collected at home and analyzed by an algorithm developed with machine learning.
- A laboratory developed test from the company's own CLIA certified laboratory.
- A screen for people with no symptoms across more than 50 cancer types.
- A predicted site of origin when a cancer signal is found.
- A published list price of $949, with an FDA application pending.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. GRAIL and bioAffinity Technologies are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | GRAIL | bioAffinity Technologies |
|---|---|---|
| Primary category | Diagnostics & Genomics | Diagnostics & Genomics |
| Founded | 2016 | 2014 |
| Headquarters | Sunnyvale, California | San Antonio, Texas |
| Website | grail.com | bioaffinitytech.com |
Side by Side
Select any grade to read the note behind it.
Product updates
The latest logged changes from each vendor, newest first, each linked to its source.
GRAIL
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Regulatory / FDA
The FDA Molecular and Clinical Genetics Devices Panel voted on GRAIL's Premarket Approval application for the Galleri multi cancer early detection blood test, for screening adults aged 50 and older.
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Clinical evidence
Nature Medicine published PATHFINDER 2, the registrational US study of Galleri, with 35,878 enrolled and 32,007 participants analyzable for performance.
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Clinical evidence
Nature Medicine published Galleri test performance from the randomized NHS-Galleri trial across three annual screening rounds in England.
Source
bioAffinity Technologies
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Product / capability
bioAffinity extended CyPath Lung from early detection into surveillance of lung cancer survivors.
Source
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Multi cancer early detection company (NASDAQ: GRAL). The Galleri test uses targeted methylation sequencing of cell-free DNA from a blood draw, with machine learning classifiers that detect a cancer signal and predict its origin, across more than 50 cancer types. It is prescription only, offered as a laboratory developed test from GRAIL's CLIA certified, CAP accredited laboratory in Durham, North Carolina, and intended for use in addition to guideline recommended screening.
Source: AI Health Index, September 2026
Lung cancer diagnostics company (NASDAQ: BIAF). CyPath Lung is a noninvasive laboratory developed test for high risk patients with indeterminate pulmonary nodules: an induced sputum sample, collected at home over three days, is labeled with antibodies and a fluorescent porphyrin taken up preferentially by cancer and cancer related cells, run on a flow cytometer, and analyzed by a patented algorithm developed with machine learning that reports Likely or Unlikely with a probability score to the ordering physician.
Source: AI Health Index, September 2026
Questions buyers ask
How are GRAIL and bioAffinity Technologies priced and sold?
For GRAIL, some TRICARE plans cover the test, and Priority Health covers it in two Medicare Advantage plans.
With bioAffinity Technologies, the annual report names the Medicare proprietary laboratory analysis code for the test, 0406U, effective 1 January 2024. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
How do GRAIL and bioAffinity Technologies handle patient data?
GRAIL's HIPAA notice of privacy practices covers test results and genetic information, and states that GRAIL will not sell a patient's PHI without written authorization and will not disclose it to third parties for marketing without authorization.
For bioAffinity Technologies, the company's 2025 annual report describes a cyber risk program with industry standard encryption, critical data backups, access management and incident response. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
Which settings and specialties do GRAIL and bioAffinity Technologies cover?
With GRAIL, the studies behind the test enrolled adults aged 50 and older (PATHFINDER 2, at US and Canadian sites) and aged 50 to 77 (NHS-Galleri, in England), and the indication before FDA is screening adults aged 50 and older.
In bioAffinity Technologies' case, the company also sells to VA and DoD physicians through a separate ordering route and presented veteran focused data in September 2026. In September 2026 the company extended the test to surveillance of lung cancer survivors after curative treatment, positioned to complement CT when monitoring for recurrence and evaluating new or changing nodules. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
What evidence is published for GRAIL and bioAffinity Technologies?
For GRAIL, the incidence of stage III or IV cancer across 12 prespecified cancers did not differ between the groups (incidence rate ratio 1.03, 95 percent confidence interval 0.92 to 1.14). Stage IV cancer, a key secondary endpoint, had a ratio of 0.86 (0.74 to 1.00).
With bioAffinity Technologies, the headline figures on the home page (92 percent sensitivity, 87 percent specificity, 88 percent accuracy) come from the under 20 millimeter subgroup of the development cohort, not from the independent test set, whose six cancers are too few to settle performance. The company also cites an economic evaluation (Journal of Health Economics and Outcomes Research, 2024) and company case studies. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers.
Both records were reviewed on this site in September 2026. GRAIL publishes a list price for Galleri; bioAffinity does not publish one for CyPath Lung. Neither test is FDA approved.
Ask both what share of positive results turn out to be cancer in the patients your practice would test.