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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) reported record monthly unit sales for its CyPath® Lung diagnostic test in April 2026, with units up nearly 300% versus April 2025 based on preliminary unaudited data.
The company highlights accelerating physician adoption, integration into clinical workflows, and new studies and R&D to expand applications.
bioAffinity Technologies (Nasdaq: BIAF) reported Q1 2026 results and growing adoption of CyPath® Lung. Unit sales rose 146% YoY; CyPath testing revenue was $361,000 (≈114% increase). Total revenue was $1.4M (down ~27%). Q1 net loss was $3.6M or $(0.81) per share. Cash and cash equivalents were $3.1M as of March 31, 2026. The company launched a large longitudinal trial (up to 20 sites) partially funded by the U.S. Department of Defense and reported a 40-patient collaborative study at Brooke Army Medical Center.
bioAffinity Technologies (Nasdaq: BIAF) launched a pilot study with Brooke Army Medical Center to evaluate its flow cytometry+AI tests for identifying inflammatory biomarkers in asthma and COPD. The study will enroll ~40 participants across asthma, COPD and healthy-control cohorts to assess sputum immune cells and cytokines.
The collaboration aims to support precision diagnostics and treatment monitoring for airway diseases and references a potential asthma/COPD treatment market estimated at $92 billion.
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.