bioAffinity Technologies vs Freenome (2026)
Both are machine learning cancer tests, used at different points. bioAffinity Technologies' CyPath Lung is for high risk patients who already have an indeterminate lung nodule: sputum collected at home over three days is labeled and run on a flow cytometer, and an algorithm developed with machine learning reports Likely or Unlikely with a probability score. It is a laboratory developed test, and its development study drew on 150 patients. Freenome screens people with no symptoms. SimpleScreen CRC, approved by FDA in July 2026 for colorectal cancer screening in average risk adults 45 and older, reads cell free DNA methylation alongside protein and autoantibody signals. Its validation study enrolled 48,995 adults and reported 79.2 percent sensitivity for colorectal cancer and 12.5 percent for advanced precancerous lesions. One helps decide what a nodule is; the other decides who needs a colonoscopy. They answer different clinical questions and are rarely alternatives.
- A test for patients who already have an indeterminate lung nodule, from sputum collected at home.
- A machine learning algorithm reporting Likely or Unlikely with a probability score to the ordering physician.
- A laboratory developed test run in the company's own CLIA certified laboratory.
- Colorectal cancer screening for average risk adults 45 and older, approved by FDA in July 2026.
- A blood test reading cell free DNA methylation, proteins and autoantibodies.
- A validation study of 48,995 adults at 201 centers, published in JAMA.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. bioAffinity Technologies and Freenome 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 | bioAffinity Technologies | Freenome |
|---|---|---|
| Primary category | Diagnostics & Genomics | Diagnostics & Genomics |
| Founded | 2014 | 2014 |
| Headquarters | San Antonio, Texas | Brisbane, California |
| Website | bioaffinitytech.com | freenome.com |
Side by Side
Select any grade to read the note behind it.
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.
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
Blood-based cancer screening company (NASDAQ: FRNM) whose multiomics platform reads cell-free DNA methylation at single base resolution, alongside protein and autoantibody signals, with machine learning classifiers producing the result.
Source: AI Health Index, September 2026
Questions buyers ask
How are bioAffinity Technologies and Freenome priced and sold?
For bioAffinity Technologies, the annual report names the Medicare proprietary laboratory analysis code for the test, 0406U, effective 1 January 2024.
Freenome sells its own configuration to health systems through a Founding Partner program: SimpleScreen Lung, a laboratory developed test, with SimpleScreen CRC and its digital tools. The company states that the approved test meets Medicare's coverage criteria. 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 bioAffinity Technologies and Freenome handle patient data?
In bioAffinity Technologies' case, the company's 2025 annual report describes a cyber risk program with industry standard encryption, critical data backups, access management and incident response.
Freenome's HIPAA notice of privacy practices (effective 13 July 2026) states that it never shares a patient's information for marketing or sale without written permission, and that it may use or share information for health research. 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 bioAffinity Technologies and Freenome cover?
With bioAffinity Technologies, 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.
In Freenome's case, the company also sells SimpleScreen Lung to health systems in its Founding Partner program, for adults aged 50 to 80 with a 20 pack-year smoking history who have not had low-dose CT screening. Its performance appears in a 2026 conference abstract, with no peer reviewed validation listed, so that part of the named coverage runs ahead of its evidence. 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 much do bioAffinity Technologies and Freenome leave to the clinician?
For bioAffinity Technologies, the company describes the test as not intended as a sole diagnostic tool, to be considered with other clinical findings, and its annual report cautions that statements about the test's ability to indicate cancer probability are forward looking.
With Freenome, a positive result is followed by colonoscopy; after a negative result screening continues on clinical judgment, and a repeat test is due in three years if the patient chooses it again. 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.
Both records were reviewed on this site in September 2026. Neither company publishes a price for these tests; Abbott holds the US commercial rights to Freenome's colorectal test.
Ask both how their test performed in the population you would actually use it on, and what happens after a negative result.