bioAffinity Technologies, Inc. develops and commercializes noninvasive diagnostics for lung cancer and other lung diseases. The company’s first product, CyPath® Lung, is a sputum-based Laboratory Developed Test marketed by Precision Pathology Laboratory Services, a bioAffinity subsidiary, and uses flow cytometry with automated AI-informed analysis to identify cell populations associated with lung malignancy.
Recurring company news centers on CyPath® Lung commercialization, physician adoption, clinical case studies, pulmonary nodule management, lung cancer risk assessment, and post-treatment surveillance. Updates also cover financial results, laboratory-services focus, medical conference and physician-education activity, and research extending the company’s flow cytometry+AI platform toward asthma and COPD diagnostics.
bioAffinity Technologies (Nasdaq: BIAF) will host a live virtual physician roundtable on April 8, 2026 to discuss integrating CyPath® Lung into pulmonary practice.
The webinar will feature pulmonologists presenting real-world cases showing CyPath® Lung identifying Stage 1A cancers and reducing unnecessary invasive procedures, and will be recorded.
bioAffinity Technologies (Nasdaq: BIAF) published a clinical case study showing its noninvasive CyPath® Lung test informed care for a 71-year-old high-risk patient with multiple pulmonary nodules.
The test returned an “Unlikely Malignancy” result; a three-month CT follow-up in October 2025 showed resolution of suspicious nodules and stability of another, avoiding invasive biopsy.
Clinical study metrics: 92% sensitivity, 87% specificity, 88% accuracy for detecting lung cancer in nodules 20 mm.
bioAffinity Technologies (Nasdaq: BIAF) reported 2025 results highlighting commercialization progress for its noninvasive lung cancer test, CyPath® Lung. CyPath testing revenue rose 87% YoY and unit volume increased 99% YoY, while consolidated revenue fell 34% after discontinuing unprofitable pathology services. The company raised $16.9M, ended 2025 with $6.5M cash, and enrolled the first patient in a planned 2,000-patient longitudinal trial in March 2026.
bioAffinity Technologies (Nasdaq: BIAF) initiated a 2,000-patient, large-scale longitudinal clinical study to evaluate its CyPath® Lung noninvasive flow cytometry test for detecting early-stage lung cancer in high-risk patients with 6mm–<30mm nodules.
Up to 20 sites, including VA centers and major military hospitals, will enroll patients over ~18 months with follow-up to 24 months (NCT07168993). Prior data showed 92% sensitivity, 87% specificity and 88% accuracy in nodules <20mm. The investigational assay will be called FlowPath Lung during the trial.
bioAffinity Technologies (Nasdaq: BIAF) presented a scientific poster at the AAAAI 2026 annual meeting on March 1, 2026, reporting that its diagnostic platform can detect antibody drug receptors in sputum for dupilumab and benralizumab.
The research advances development of noninvasive tests to help match asthma and COPD patients with biologic therapies and to monitor inflammatory changes over time using the company's flow cytometry platform with automated AI analysis.
bioAffinity Technologies (Nasdaq: BIAF) announced a validation study with Brooke Army Medical Center to test CyPath® Lung on sputum obtained by tracheal and bronchial suctioning.
The study will enroll approximately 30–50 patients, with results expected by mid‑2026, aiming to expand sample collection options and clinical utility.
bioAffinity Technologies (Nasdaq: BIAF) published a clinical case study showing its noninvasive CyPath® Lung test supported conservative management for a 79-year-old high-risk woman with a suspicious lung nodule detected on an LDCT in June 2025.
The CyPath Lung result was negative, the team deferred biopsy, and a repeat CT in October 2025 showed the nodule had resolved. The company reports CyPath Lung has 92% sensitivity, 87% specificity, and 88% accuracy for nodules under 2 cm, and the test complemented imaging to reduce invasive procedures.
bioAffinity Technologies (Nasdaq: BIAF) reported a real-world case study showing its noninvasive CyPath® Lung test aided clinical decision-making for a high-risk patient with multiple small pulmonary nodules. The test demonstrated 92% sensitivity, 87% specificity, and 88% accuracy for nodules <2 cm and returned a negative result, supporting six-month CT surveillance and avoiding invasive procedures.
The case highlights reduced patient anxiety and increased physician confidence when using CyPath Lung as an adjunctive tool for Lung-RADS 3 nodules in high‑risk smokers.
bioAffinity Technologies (Nasdaq: BIAF) appointed three nationally recognized pulmonary and lung cancer specialists — David Ost, MD, MPH; Daniel Sterman, MD; and J. Scott Ferguson, MD — to its Medical and Scientific Advisory Board on February 9, 2026.
The advisory additions aim to support clinical, scientific, and commercial priorities, including wider integration and adoption of the CyPath® Lung noninvasive diagnostic test for indeterminate pulmonary nodules into standard care.
bioAffinity Technologies (Nasdaq: BIAF) announced that its wholly owned laboratory, Precision Pathology Laboratory Services (PPLS), has maintained College of American Pathologists (CAP) accreditation after a rigorous on-site inspection, reaffirming laboratory quality, accuracy and patient safety.
The company said PPLS, acquired in September 2023, generates revenue from anatomic and clinical pathology services and supports long-term growth for its noninvasive CyPath® Lung diagnostic, which the company says can detect lung cancer as early as Stage 1A. The release cites a U.S. lung cancer diagnostics market of $4.8 billion in 2024 projected to reach $10.4 billion by 2034 (8.1% CAGR).