GRAIL vs bioAffinity Technologies
These two get shelved together as AI cancer detection and they answer different clinical questions. GRAIL's Galleri is a screening test: a blood draw for asymptomatic people, detecting signals across more than 50 cancer types, backed by the largest evidence base in this index and an active FDA Premarket Approval application. bioAffinity's CyPath Lung is a diagnostic aid: a sputum test for a patient who already has an indeterminate lung nodule, where the job is deciding whether to cut. If you are building a population screening program, Galleri is the category. If you are trying to avoid unnecessary bronchoscopies on small nodules, CyPath Lung is the tool, and its 99 percent reported negative predictive value is the number that matters. Buying one instead of the other is a category error.
- The question is screening: finding cancer in people with no symptoms and no known nodule, across more than 50 cancer types from a single blood draw, as an addition to standard of care single cancer screening.
- Evidence depth is the deciding factor: PATHFINDER 2 enrolled 25,490 participants and the NHS-Galleri trial enrolled more than 140,000 asymptomatic participants, the only prospective randomized controlled trial of population screening with a multi cancer test.
- You want a defined regulatory trajectory: Breakthrough Device designation since 2018 and a Premarket Approval application with its final module submitted to FDA in January 2026.
- The question is diagnosis, not screening: a patient already has a small indeterminate pulmonary nodule found on imaging and the clinical decision is whether to pursue invasive follow up.
- Ruling out matters more than ruling in: the vendor reports a 99 percent negative predictive value in high risk patients with nodules under 20 millimeters, which is the figure that spares patients unnecessary procedures.
- You want a low friction sample: a sputum sample collected at home, analyzed by flow cytometry with automated ML analysis, with results typically returned to physicians in about two days.
Side-by-Side
| Axis |
G
GRAIL
|
B
bioAffinity Technologies
|
|---|---|---|
| AI Centrality | B — Vendor Published | B — Regulatory Filing |
| Autonomy and Oversight Model | — | — |
| Model and Technology Transparency | — | — |
| Clinical and Operational Evidence | A — Vendor Published | B — Vendor Published |
| AI Safety and PHI Stewardship | — | — |
| HIPAA and BAA Posture | — | — |
| Security Certifications and Trust Center | — | — |
| FDA and Regulatory Status | A — Regulatory Filing | B — Regulatory Filing |
| AI Governance and Bias Disclosure | — | — |
| EHR and Interoperability Depth | — | — |
| Deployment Model and Data Residency | — | — |
| Commercial Transparency | Not Rated — Vendor Published | C — Regulatory Filing |
| Setting and Specialty Coverage | A — Vendor Published | A — Vendor Published |
These tests are not substitutes and a buyer choosing between them is usually asking the wrong question. Both are currently offered as laboratory developed tests; neither is FDA approved. Performance figures for both are vendor reported and have not been independently validated by this index. bioAffinity states explicitly that CyPath Lung is not intended as a sole diagnostic tool. Neither vendor publishes a rate card for institutional purchasing.