bioAffinity Technologies

Per the company's SEC filings, automated analysis developed by machine learning standardizes sample data analysis and patient test results, and the platform is described as flow cytometry plus AI. Held back from A because the diagnostic signal originates in the wet lab chemistry (a fluorescent porphyrin preferentially taken up by cancer cells) with ML performing the classification layer over it.

Specific performance figures are published from a clinical trial in high risk patients with indeterminate nodules under 20 millimeters: 92 percent sensitivity, 87 percent specificity, 88 percent accuracy, and 99 percent negative predictive value. Held back from A because the trial cohort size is not stated in the retrieved materials and the supporting evidence is largely company published case studies and conference posters rather than large prospective trials.

Stated clearly: CyPath Lung is marketed as a laboratory developed test through the company's own CLIA laboratory, and the company explicitly states it is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. No FDA clearance is claimed. Held back from A because no active regulatory pathway or timeline is disclosed.

Structure is inferable rather than published: the test is sold to physicians through the company's own pathology laboratory and is reimbursed by Medicare and private insurance carriers, per SEC filings. No list price is published.

Tightly and honestly scoped: physicians ordering for high risk patients with small indeterminate pulmonary nodules, as an aid to decision making rather than a screening test for the general population. Narrow coverage clearly stated is exactly what this axis rewards.