Welcome to our dedicated page for bioAffinity Tech news (Ticker: BIAF), a resource for investors and traders seeking the latest updates and insights on bioAffinity Tech stock.
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) is a biotechnology company focused on noninvasive diagnostics and early detection of lung cancer and other lung diseases. News about bioAffinity Technologies often centers on its flagship product, CyPath® Lung, a noninvasive sputum-based test that uses advanced flow cytometry and proprietary artificial intelligence to identify cell populations indicating malignancy in high-risk patients.
Investors and clinicians following BIAF news will see updates on clinical performance and real-world use of CyPath® Lung, including case reports where the test has contributed to detecting Stage 1A lung cancer in patients with indeterminate pulmonary nodules and complex diagnostic profiles. Company announcements also describe growing test volumes, reported increases in CyPath® Lung revenues and adoption by physicians, health systems and Veterans Administration medical centers.
Another key news theme is regulatory and quality milestones. bioAffinity Technologies issues releases on the College of American Pathologists (CAP) accreditation status of its wholly owned subsidiary, Precision Pathology Laboratory Services, and on CLIA certification that underpins its laboratory operations. These updates highlight the laboratory’s role in delivering CyPath® Lung and other pathology services with an emphasis on quality, accuracy and patient safety.
News flow also covers intellectual property and platform development, including notifications of allowance for U.S. patents that protect the AI-built algorithm and flow cytometry platform behind CyPath® Lung, and accepted patent applications in jurisdictions such as Australia for systems and methods to determine lung health. In addition, bioAffinity Technologies reports on capital-raising activities, Nasdaq listing compliance, participation in scientific conferences like CHEST and the American Cancer Society National Lung Cancer Roundtable, and presentations that detail research on sample handling and diagnostic performance.
This BIAF news page aggregates these company disclosures, providing a single view of developments in noninvasive lung cancer diagnostics, laboratory quality achievements, patent progress and corporate actions related to bioAffinity Technologies.
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).
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.