bioAffinity Technologies, Inc. (NASDAQ: BIAF)

bioAffinity Technologies develops noninvasive diagnostic laboratory tests to detect early-stage lung cancer and other lung diseases using flow cytometry and automated analysis informed by machine learning. The company's primary commercial product is CyPath® Lung, which identifies and analyzes cell populations in sputum to indicate malignancy in the lung. CyPath® Lung is performed by the company's wholly owned subsidiary PPLS, a CAP-accredited and CLIA-certified clinical anatomic and pathology laboratory that has operated for more than 18 years.

The company generates revenue primarily through the sale of CyPath® Lung tests to physicians who order the test to assist in assessing patients at high risk for lung cancer. Revenue is also derived from ongoing development of companion diagnostic tests for asthma and chronic obstructive pulmonary disease (COPD) using the same flow cytometry and AI platform. Additional revenue comes from research collaborations, including those with Brooke Army Medical Center, focused on expanding the utility of bronchoscopy-collected samples for earlier lung cancer detection.

The company operates through the following segments:

• CyPath® Lung: This segment focuses on the commercialization and delivery of the company's first diagnostic test for early-stage lung cancer detection. CyPath® Lung uses flow cytometry and artificial intelligence to analyze sputum samples for cancer and cancer-related cells. The test provides a physician’s report within three days of sample arrival, stratifying patients into risk categories based on a numerical probability score.

• Companion Diagnostics for Asthma and COPD: This segment involves the development of diagnostic tools to quantify lung inflammation and identify patients likely to benefit from specific biologic therapies. Research in this area aims to match patients with effective treatments and monitor disease progression using sputum analysis. The segment leverages the company's flow cytometry platform with AI analysis to detect therapeutic targets such as receptors for dupilumab and benralizumab.

• OncoSelect® Therapeutics: This segment conducts research on novel cancer therapeutic approaches that selectively target cancer cells. Work includes the development of topical treatments for squamous cell skin cancer based on discoveries involving the synthetic porphyrin TCPP. The company intends to seek strategic partners to advance these findings toward broad-spectrum cancer treatments. Research is conducted in laboratories at PPLS and through collaborations with academic institutions.

bioAffinity Technologies operates in the competitive lung cancer diagnostics market, where it positions itself as a provider of noninvasive, cost-effective tests with high sensitivity and specificity. The company's CyPath® Lung test demonstrates 92% sensitivity and 87% specificity for nodules under 20 mm, outperforming several competitors in balance and accuracy. Competitors include LungLB by LungLife AI, Nodify XL2 and Nodify CDT by Biodesix, and the Percepta nasal swab test by Veracyte, all of which show lower performance in key metrics or limitations in usability across patient populations.

The company serves physicians who order diagnostic tests for patients at high risk of lung cancer, particularly those with indeterminate pulmonary nodules detected by CT imaging. Specific customers include Brooke Army Medical Center, Walter Reed Medical Center, and the South Texas Audie L. Murphy Memorial Veterans Medical Center, which participate in clinical trials and research collaborations. The company also works with healthcare providers in academic, military, and VA medical centers to advance adoption of its diagnostic technology.