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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) 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).
bioAffinity Technologies (Nasdaq: BIAF) announced that Chief Medical Officer Gordon Downie, MD, PhD will present a poster at the American Cancer Society National Lung Cancer Roundtable on Dec 8, 2025 highlighting three clinical cases where CyPath® Lung, a noninvasive sputum-based flow cytometry test, identified Stage 1A lung cancer in diagnostically challenging patients.
The poster, "CyPath® Lung in Practice: From Uncertainty to Clarity and Confidence," describes use of CyPath Lung alongside LDCT, PET, risk calculators, bronchoscopy, and serum markers; sessions are scheduled Dec 8, 2025, 2:35–3:15 p.m. ET, and the poster will be available on the company website.
bioAffinity Technologies (Nasdaq: BIAF) reported third quarter 2025 results highlighting strong commercial traction for CyPath® Lung alongside strategic restructuring. Key metrics: CyPath Lung revenues +86% year‑to‑date and tests processed +97% for the first nine months of 2025; Q3 CyPath sales hit a record, up 92% sequentially and 122% year‑over‑year for the quarter. Total revenue declined to $1.5M from $2.4M due to discontinuing unprofitable pathology services. Net loss was $5.1M (loss of $4.74/share), driven partly by warrant fair value expense. Cash was $7.7M at 9/30/2025 after raising $10.4M in gross equity proceeds. Company regained Nasdaq compliance and added a U.S. patent and two board members.
bioAffinity Technologies (Nasdaq: BIAF) reported accelerating month‑over‑month growth for its noninvasive lung cancer test, CyPath® Lung. October 2025 test volume was 111% higher than the 2025 year‑to‑date monthly average and marks more than a twofold increase since the start of 2025. Third‑quarter sales volume rose 95% QoQ. Practices placing multiple orders grew 106% in Q3 and were 67% higher in October versus the 2025 monthly average. Management described steady adoption by pulmonologists, health systems, and VA centers and expects the trend to continue.
bioAffinity Technologies (Nasdaq: BIAF) announced that IP Australia has accepted Australian patent application AU 2019253111 for its platform to assess lung health and predict multiple lung diseases. The application covers methods using flow cytometry with fluorescent probes to detect cellular and molecular signatures in sputum samples. The acceptance adds to bioAffinity’s global estate—18 awarded and 33 pending patents—and complements the company’s flagship CyPath® Lung diagnostic. The patent will be automatically issued three months after acceptance unless a third party files an opposition before issuance.
bioAffinity Technologies (Nasdaq: BIAF) will present research at CHEST 2025 (Oct 19-22) supporting the CyPath® Lung sample collection and transport methods used for its noninvasive lung cancer test.
Rossella Titone, PhD, will present the poster “The Effect of Sputum Storage and Shipping Temperature on Flow Cytometric Outcomes of Sputum-Based Diagnostic Tests” on October 22, 2025 at 10:20 a.m. at poster board #4324. The company said the study validates protocols for home-collected sputum shipped to its lab, with physicians typically receiving results in two days. BioAffinity will be at Booth #2242 and highlighted recent case studies detecting Stage 1A lung cancers.
bioAffinity Technologies (Nasdaq: BIAF) received a notification of allowance from the USPTO for a patent titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.”
The allowed claim covers an AI-built algorithm and automated flow cytometry system that analyzes sputum cell populations and patient age to predict early-stage lung cancer and supports the company’s commercial CyPath® Lung test. The allowance expands bioAffinity’s global estate to 18 awarded and 33 pending patents across multiple jurisdictions.