bioAffinity Technologies vs Freenome (2026)
If your failure mode is treating these as competing early detection tests, start by noticing they screen different cancers. bioAffinity's CyPath Lung analyzes a sputum sample to help a physician decide about a small indeterminate lung nodule; Freenome's SimpleScreen CRC is a blood test for average risk colorectal screening. A clinician rarely chooses between them, so the sharper comparison is regulatory posture and evidence. Freenome sits at the higher bar: a Premarket Approval application under FDA review with a decision anticipated in 2026, a pivotal study published in JAMA, and inclusion in the American Cancer Society's updated colorectal guideline. bioAffinity is a laboratory developed test through its own CLIA lab with strong reported accuracy but company published evidence and no disclosed FDA pathway. One is a regulated screening play; the other is a lab offered decision aid.
- The right tool for the specific question CyPath Lung answers: a physician assessing a high risk patient with a small indeterminate pulmonary nodule under 20 millimeters, where reported performance is 92 percent sensitivity and a 99 percent negative predictive value.
- Available now as a laboratory developed test through the company's own CLIA lab, reimbursed by Medicare and private carriers, without waiting on a premarket decision.
- Honestly scoped as an aid alongside other clinical findings rather than a sole diagnostic or a population screen, which is the correct framing for a nodule workup.
- The stronger regulatory and evidence position: a Premarket Approval application under FDA review with a 2026 decision anticipated, a pivotal PREEMPT CRC study published in JAMA, and independent inclusion in the American Cancer Society colorectal screening guideline.
- A blood draw for average risk colorectal screening, a far larger and better defined population than a nodule decision aid, with 85 percent reported sensitivity for colorectal cancer at 90 percent specificity.
- Unusually candid scope: the company states plainly that no single technology detects every cancer, the right posture for a category prone to overclaiming.
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 | Not recorded |
| Headquarters | San Antonio, Texas | Brisbane, California |
| Website | bioaffinitytech.com | freenome.com |
Side by Side
Each record in one paragraph
Written to be quoted whole. Each paragraph states what the AI Health Index verified about the vendor, with the caveats attached. Generated from this pair’s live capability grades, so it moves when a grade moves.
The AI Health Index awards bioAffinity Technologies its top capability grade on Autonomy and Oversight Model and Setting and Specialty Coverage. Set against Freenome, bioAffinity Technologies does not grade higher on any scored axis, though the two are level on several axes, including AI Centrality, Autonomy and Oversight Model and Model Supply Chain Disclosure. Its thinnest published disclosure sits on Model Supply Chain Disclosure. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
The AI Health Index awards Freenome its top capability grade on several axes, including Autonomy and Oversight Model, Clinical and Operational Evidence and FDA and Regulatory Status. Set against bioAffinity Technologies, Freenome grades higher on several axes, including Model and Technology Transparency, Clinical and Operational Evidence and FDA and Regulatory Status. Its thinnest published disclosure sits on Model Supply Chain Disclosure. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
Questions buyers ask
Should we choose bioAffinity Technologies or Freenome?
The AI Health Index grades Freenome higher than bioAffinity Technologies on every axis that separates them, several axes, including Model and Technology Transparency, Clinical and Operational Evidence and FDA and Regulatory Status. bioAffinity Technologies does not grade higher on any scored axis.
Where do bioAffinity Technologies and Freenome differ most?
The widest separation the AI Health Index records between bioAffinity Technologies and Freenome is on Model and Technology Transparency, where bioAffinity Technologies grades C and Freenome grades B. That axis sits in the AI Capability group, so it should carry the most weight for a buyer whose binding constraint is how much of the work the model itself is trusted to do.
Where do bioAffinity Technologies and Freenome grade the same?
The AI Health Index grades bioAffinity Technologies and Freenome the same on several axes, including AI Centrality, Autonomy and Oversight Model and Model Supply Chain Disclosure. Neither holds an advantage the index can evidence on those axes, so they should not carry weight in a selection between these two.
What have bioAffinity Technologies and Freenome not disclosed?
At the last review, at least one of bioAffinity Technologies and Freenome published thin or absent detail on Model Supply Chain Disclosure. The AI Health Index treats an absent disclosure as a gap in the public record rather than a failure of the product, so these are the axes to get in writing during diligence instead of inferring from the grade.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Diagnostics & Genomics page.
These screen different cancers by different sample types, so the comparison is about regulatory route and evidence, not head to head accuracy. Freenome's evidence is peer reviewed and independently recognized, but its PMA is still under review and not approved, and under an exclusive license Exact Sciences holds US commercial rights, so a buyer's counterparty may not be Freenome. bioAffinity's accuracy figures come from a trial whose cohort size is not stated in retrieved materials and are supported largely by company case studies and conference posters, with no active FDA pathway disclosed. Both are wet lab assays with a machine learning classifier layered over sample chemistry, graded B on AI centrality for the same reason as GRAIL: the chemistry is as load bearing as the model.