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bioAffinity Technologies, Inc. develops noninvasive diagnostic tests for lung cancer and other lung diseases, with recurring news centered on its CyPath® Lung sputum-based diagnostic. Company updates describe clinical case studies, physician education, pulmonary nodule management, commercialization of the test, and laboratory services provided through Precision Pathology Laboratory Services.
News also covers bioAffinity’s flow cytometry and automated analysis platform, including research directed at asthma and chronic obstructive pulmonary disease diagnostics. The company reports developments involving clinical studies, scientific presentations, test adoption, revenue trends, equity financings, and the use of CyPath® Lung as a Laboratory Developed Test under CLIA oversight.
bioAffinity Technologies (NASDAQ: BIAF) published a clinical case study showing its noninvasive sputum test CyPath® Lung supported physician judgment, prompted follow-up imaging and helped defer an unnecessary lung biopsy for a high‑risk 70‑year‑old patient on April 14, 2026.
The company reports the test showed 92% sensitivity, 87% specificity and 88% accuracy in a clinical trial of difficult-to-diagnose small nodules; the patient’s initial 30 mm nodule fully resolved on repeat CT after a negative CyPath result, avoiding a risky invasive procedure.
bioAffinity Technologies (Nasdaq: BIAF) will feature its CyPath® Lung test at the Cleveland Clinic "Advances in Early Lung Cancer Detection" symposium on April 16, 2026. Chief Medical Officer Gordon Downie, MD, PhD, will join a panel on lung nodule management to discuss CyPath® Lung's role in early detection.
The invitation-only event focuses on risk assessment, screening biomarkers, AI, and emerging diagnostics to find lung cancer at its most treatable stages.
bioAffinity Technologies (Nasdaq: BIAF) reported that CyPath Lung unit sales in Q1 2026 rose 146% year-over-year on preliminary unaudited data, reflecting accelerating physician adoption. The company noted 2025 revenue +87% YoY and test units +99% vs 2024, targeting a $3.58B U.S. addressable market.
Management highlighted clinical use in nodule management, a planned large longitudinal study, and R&D into asthma and COPD diagnostics to broaden the platform.
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.