- No public price.
- Not disclosed
- Not disclosed
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- —
- US
Pathology
bioAffinity Technologies
by bioAffinity Technologies, Inc. · US
CyPath Lung sputum test: flow cytometry with a machine learning classifier for lung cancer risk. Lab-developed test, not FDA cleared.
On this page
6/100
Not rated: too little independent evidence yet.
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- Vendor & Market3/18
Seed-stage or unfunded
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance0/18
No FDA clearance listed
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers0/21
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market0/6
Founded year not recorded
- Pricing transparency3/5
Pricing on request, no public amounts
CyPath Lung sputum test: flow cytometry with a machine learning classifier for lung cancer risk. Lab-developed test, not FDA cleared.
No public price.
Evidence record
No FDA decision cited in our research as of November 2, 2026.
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, bioAffinity Technologies record, https://medaiverdict.com/tools/bioaffinity-technologies, version November 2, 2026
Bottom line
CyPath Lung is a noninvasive sputum test from bioAffinity Technologies of San Antonio. Patients collect the sample at home with a kit, and the company's lab runs automated flow cytometry with a machine-learning classifier to score lung cancer risk. The vendor labels it a laboratory developed test, and it is not an FDA-cleared device. Physicians treating a patient with a pulmonary nodule under 20 millimetres after screening are the users the vendor describes. A buyer who needs a cleared device will not find one, and the performance figures it cites come from a paper by vendor-affiliated authors.
How is a sample collected and scored?
bioAffinity's line is "flow cytometry+AI to detect lung cancer when it's most treatable", and it says the test detects lung cancer as early as its curative Stage 1A. The physician receives a result and a probability score. The classifier runs in the central lab, so the clinician operates no software.
The vendor says physicians order the test for patients after screening or after an incidental nodule. A figure caption on the products page narrows that to individuals at high risk with pulmonary nodules smaller than 20 millimetres.
What performance does bioAffinity quote?
The vendor cites a 95% area under the curve, 99% negative predictive value and 44% positive predictive value. It attributes them to a January 2023 paper in Respiratory Research (PMID 36681813), whose authors are affiliated with bioAffinity and Precision Pathology. On the same vendor page the fields for sensitivity, specificity and accuracy hold placeholder values of "0 %".
A 2024 economic evaluation in the Journal of Health Economics and Outcomes Research examines CyPath Lung in patients with a positive low-dose CT. A 2015 paper in the Journal of Thoracic Oncology on TCPP-labeled sputum used an earlier method by related authors and is not clearly about the current product.
Is CyPath Lung FDA cleared?
The products page states twice: "This test is a Laboratory Developed Test." Precision Pathology Laboratory Services in San Antonio runs it and is CAP-accredited and CLIA-certified.
How is it sold?
bioAffinity trades under the ticker BIAF. Veterans and federal facilities order through a procurement page on precisionpath.us. The products page lists no price and gives no insurance information.
The verdict
CyPath Lung suits a physician whose patient has a small pulmonary nodule and who accepts a laboratory developed test scored by a vendor classifier. It does not suit a buyer who needs an FDA-cleared device or performance figures with confidence intervals: the cited 95% area under the curve rests on one paper from bioAffinity-affiliated authors, and the vendor page shows placeholder values where sensitivity and specificity would sit.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. |
Source: vendor pricing page. Last checked November 2, 2026.
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