Welcome to our dedicated page for bioAffinity Tech SEC filings (Ticker: BIAF), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The bioAffinity Technologies, Inc. (BIAF) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures filed with the U.S. Securities and Exchange Commission. As a Nasdaq Capital Market issuer, bioAffinity Technologies files current reports, proxy statements, registration statements and financial reports that describe its biotechnology business focused on noninvasive diagnostics and early detection of lung cancer and other lung diseases.
Through its filings, investors can review Form 8-K current reports detailing material events such as College of American Pathologists (CAP) accreditation for its subsidiary Precision Pathology Laboratory Services, notifications of allowance for U.S. and international patents protecting the CyPath® Lung platform, presentations at major medical conferences and capital-raising transactions, including registered direct offerings under an effective Form S-3 shelf registration statement. These 8-Ks also summarize developments related to Nasdaq listing compliance and monitoring.
Definitive proxy statements filed on Schedule 14A outline governance and capital structure proposals, such as warrant exercise and anti-dilution provisions, preferred stock terms, amendments to equity incentive plans and potential non-public offerings under Nasdaq rules. Together with periodic reports, these documents help explain how bioAffinity Technologies manages its equity, financing options and incentive programs while advancing CyPath® Lung and its diagnostic platform.
On Stock Titan, AI-powered tools can assist in reviewing lengthy filings by highlighting key sections related to revenue sources, laboratory operations, patent portfolio, Nasdaq compliance and financing terms. Users can quickly locate disclosures about the marketing of CyPath® Lung as a Laboratory Developed Test through Precision Pathology Laboratory Services, CAP and CLIA credentials, and the scope of the company’s global patent estate. Real-time EDGAR updates ensure that new BIAF filings, including future 10-K annual reports, 10-Q quarterly reports, 8-K current reports and proxy materials, are surfaced promptly, while AI summaries help interpret complex legal and financial language.
bioAffinity Technologies reported 2025 results showing rapid growth in its CyPath® Lung lung cancer test but a wider overall loss. Revenue from CyPath® Lung testing rose 87% year over year, with the number of tests up 99% and ordering physician sites up 67%, reflecting stronger clinical adoption.
Total 2025 revenue was
Cash and cash equivalents increased to
bioAffinity Technologies has begun a large, 2,000-patient longitudinal clinical study of CyPath® Lung, its noninvasive sputum-based test for early-stage lung cancer detection in high-risk patients with lung nodules 6 to less than 30 millimeters.
The study will run across up to 20 sites, including numerous VA medical centers and major military hospitals, with patients followed for up to 24 months or until a definitive cancer or no-cancer diagnosis. An earlier trial showed 92% sensitivity, 87% specificity and 88% accuracy in high-risk patients with nodules less than 20 millimeters.
The new trial, supported in part by the John P. Murtha Cancer Center Research Program, uses a research-use version called FlowPath Lung that applies the same flow cytometry and AI technology as the commercially available CyPath® Lung Laboratory Developed Test.
bioAffinity Technologies, Inc. reported that directors Robert Anderson and Roby Joyce have chosen not to stand for re-election when their current terms expire at the company’s 2026 Annual Meeting of Stockholders, currently scheduled for April 30, 2026.
The company stated that the decisions by Mr. Anderson and Mr. Joyce are not due to any disagreements with bioAffinity Technologies regarding its operations, policies, or practices. Both will continue to serve as directors until their terms end at the 2026 Annual Meeting.
bioAffinity Technologies is soliciting proxies for its Annual Meeting on April 30, 2026. The Company asks stockholders to elect six directors and ratify WithumSmith+Brown, PC as auditor. Key voting items seek approval to issue up to 271,500 shares on exercise of August 2025 warrants; approve a warrant anti-dilution adjustment increasing potential warrant shares to 365,620; approve a Series B anti-dilution adjustment increasing potential conversion shares to 131,884; amend the 2024 Equity Incentive Plan to reserve 1,000,000 shares (up from 66,666); authorize non-public offerings and related change-of-control approval under Nasdaq rules; and approve a reverse stock split at a ratio of 1-for-2 to 1-for-250 at the Board’s discretion.
The proxy materials explain voting mechanics, quorum and vote thresholds, broker non-vote treatments, and includes the Board’s FOR recommendations on all proposals.
bioAffinity Technologies, Inc. reported that it presented a scientific poster titled “Sputum as a Diagnostic Tool for the Treatment of Asthma” at the 2026 American Academy of Allergy, Asthma and Immunology meeting in Philadelphia. The work highlights a noninvasive sputum-based diagnostic approach.
The research describes using bioAffinity’s platform to identify antibody drug receptors in sputum for asthma and COPD therapies, including dupilumab and benralizumab, to help match patients with effective biologic treatments and monitor inflammatory changes. The company notes this platform underpins its commercial CyPath® Lung test, which in clinical studies showed 92% sensitivity, 87% specificity and 88% accuracy for early lung cancer detection.
bioAffinity Technologies, Inc. is launching a validation study with Brooke Army Medical Center to test its CyPath® Lung diagnostic on sputum samples collected through tracheal and bronchial suctioning for early lung cancer detection. The study will enroll about 30–50 patients undergoing routine suction procedures, with results expected by mid-year 2026.
CyPath® Lung is a noninvasive test that uses flow cytometry, AI, and a fluorescent porphyrin to identify malignant cell populations in sputum. Prior clinical results showed 92% sensitivity, 87% specificity, and 88% accuracy in high-risk patients with small lung nodules.
The study aims to expand sample collection options beyond at-home sputum collection and leverage bronchoscopy procedures, which are performed roughly 500,000 times annually in the U.S. The company highlights a U.S. bronchoscopy-related market estimated at $700–$920 million and positions this work as a step toward broader use of CyPath® Lung.
bioAffinity Technologies, Inc. reported that a new clinical case study shows how its noninvasive CyPath® Lung test helped guide treatment for a 79-year-old high-risk patient with a suspicious lung nodule found on a low-dose CT scan.
The CyPath Lung result was negative, supporting a choice to monitor with annual CT scans instead of performing an invasive biopsy. A follow-up scan later in 2025 showed the nodule had resolved and no pulmonary nodules were present, reinforcing the conservative approach.
CyPath Lung is designed for early lung cancer detection in high-risk patients using sputum analysis, advanced flow cytometry and AI. Clinical study data cited in the case show 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in small nodules under 2 centimeters.
bioAffinity Technologies reported a new clinical case study using its CyPath® Lung diagnostic test in a high-risk 59-year-old smoker with multiple small pulmonary nodules classified as Lung-RADS 3, a category considered probably benign. A negative CyPath Lung result supported continued six-month CT surveillance rather than more invasive procedures.
The company highlights prior clinical results where CyPath Lung showed 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in high-risk patients with nodules under 20 millimeters. The test is a noninvasive, sputum-based Laboratory Developed Test marketed through Precision Pathology Laboratory Services.
bioAffinity Technologies, Inc. filed a current report to furnish updated presentation materials about the company’s operations and performance. Management intends to use these February 2026 presentation slides in meetings, and the materials were posted to the company’s website on February 10, 2026.
The materials are furnished under Regulation FD as Exhibit 99.1 and are expressly not deemed “filed” for liability purposes under the Securities Exchange Act of 1934 or incorporated by reference into other Securities Act or Exchange Act filings.
bioAffinity Technologies filed an 8-K reporting that it has expanded its Medical and Scientific Advisory Board by appointing three nationally recognized pulmonary and lung cancer specialists: Dr. David Ost of MD Anderson Cancer Center, Dr. Daniel Sterman of NYU Langone Health, and Dr. J. Scott Ferguson of the University of Wisconsin School of Medicine and Public Health.
The company develops CyPath® Lung, a noninvasive diagnostic test for early detection of lung cancer in high-risk patients with small indeterminate pulmonary nodules. In clinical studies, CyPath® Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer, supporting its role as an added tool to inform clinicians and potentially improve early-stage diagnosis.