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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) has released a case study demonstrating the effectiveness of their CyPath® Lung diagnostic test in detecting early-stage lung cancer. The test successfully identified a Stage 1A neuroendocrine tumor in an 80-year-old former smoker after other diagnostic methods, including PET scan and bronchoscopies, failed to detect malignancy.
The CyPath® Lung test returned a high score of 0.72, indicating cancer likelihood, which led to a robotic wedge resection that confirmed the presence of the tumor. This case highlights the test's potential as a valuable complement to traditional diagnostic tools, particularly for difficult-to-detect cancers in patients with indeterminate pulmonary nodules.
bioAffinity Technologies (NASDAQ: BIAF) has secured a new patent in Canada for its CyPath® Lung cancer diagnostic technology. The patent (No. 3,136,245) protects the company's method of detecting lung disease through flow cytometry analysis of sputum using defined antibodies and porphyrin TCPP.
CyPath® Lung, the company's commercially available test, has demonstrated impressive clinical results with 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules under 20 millimeters. The Canadian market represents a significant opportunity, as lung cancer is the leading cause of cancer death in Canada, with 31,000 diagnoses and 20,700 deaths reported in 2024.
bioAffinity Technologies (NASDAQ: BIAF) has received patent allowance from China's National Intellectual Property Administration for its lung cancer diagnostic method using flow cytometry. The patent, titled "System and Method for Determining Lung Health," protects the company's technology using specific antibodies and porphyrin TCPP to detect lung cancer cells in sputum.
China represents a significant market opportunity with over 300 million smokers and an estimated 1.06 million new lung cancer cases in 2022. The company's CyPath® Lung test has demonstrated impressive clinical results, including 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules.
bioAffinity Technologies (NASDAQ: BIAF) released a compelling case study demonstrating the effectiveness of their CyPath® Lung test in detecting early-stage lung cancer. The test successfully identified Stage 1A adenocarcinoma in a 70-year-old female patient when other diagnostic methods were inconclusive.
The case involved a high-risk patient with a 50+ pack-year smoking history and COPD. While PET imaging and risk models suggested low malignancy probability (0.2%), CyPath® Lung's positive result (0.83) led to surgical intervention, confirming early-stage cancer. The test is Medicare-reimbursed and available through Federal Supply Schedule, with potential cost savings of $2,733 per Medicare patient and $6,460 per private insurance patient.
bioAffinity Technologies (NASDAQ: BIAF) is presenting breakthrough cancer research at the 2025 RNA Therapeutics Conference, highlighting their patented therapeutic approach using small interfering RNAs (siRNAs) to target CD320 and LRP2 cell surface receptors. The research demonstrates selective cancer cell elimination while preserving normal cells.
The company's technology, protected by U.S. Patent No. 12,305,171 and a recently granted Chinese patent, shows promise across multiple cancer types including lung, breast, prostate, brain, and skin cancers. Research is currently focused on developing a topical treatment for skin malignancies. The presentation titled "Silencing CD320 and LRP2 by siRNAs selectively kills cancer cells: mechanistic enigmas" will be delivered by Dr. David Elzi, VP of Product Development.
bioAffinity Technologies (NASDAQ: BIAF) has secured a patent grant from China's National Intellectual Property Administration for its novel siRNA-based cancer therapy. The patent covers compositions and methods for treating cancer by targeting CD320 and LRP2 receptors on cell membranes.
The technology demonstrates effectiveness against multiple tumor types including lung, breast, prostate, brain, and skin cancers, without harming normal cells. The company is specifically developing this as a topical treatment for skin cancers. This patent complements their existing U.S. Patent No. 12,305,171 and aligns with their dual focus on diagnostics (CyPath® Lung) and therapeutics.
bioAffinity Technologies (NASDAQ: BIAF) has appointed Dr. Gordon Downie as its new Chief Medical Officer. Dr. Downie brings over 30 years of experience in pulmonary medicine, clinical research, and interventional pulmonology. He has authored more than 30 peer-reviewed publications focused on bronchoscopy, early lung cancer diagnosis, and medical device development.
Dr. Downie previously served as Director of the Lung Nodule Clinic and Interventional Pulmonology at Titus Regional Medical Center. He holds a PhD in experimental pathology from SUNY Buffalo and an MD from Northwestern University. Notably, before his medical career, he was an Olympic bronze medalist in swimming at the 1976 Summer Olympics.
In his new role, Dr. Downie will focus on scaling CyPath® Lung, the company's noninvasive diagnostic for lung cancer, and expanding their diagnostic platform to additional diseases.