bioAffinity Technologies, Inc. operates as a development-stage company addressing the significant unmet need for non-invasive, early-stage cancer diagnosis and treatment. The firm develops proprietary in-vitro diagnostic tests and targeted cancer therapeutics using breakthrough technology that preferentially targets cancer cells. The company was founded on March 26, 2014 and is headquartered in San Antonio, TX.
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- bioAffinity Technologies is expanding its noninvasive CyPath Lung test to support surveillance of lung cancer patients who have completed curative-intent treatment. - The binary-result test ("unlikely" or "likely malignancy") aims to complement imaging, which often cannot distinguish recurrence from benign post-treatment changes such as fibrosis or scarring. - Published studies report non-small cell lung cancer recurrence rates of 20% to 55%, with more than 680,000 Americans living with a prior lung cancer diagnosis. - President and CEO Maria Zannes emphasized that post-treatment surveillance could enable earlier intervention and improved patient outcomes.
- bioAffinity Technologies' CyPath Lung diagnostic test achieved 146% year-over-year unit sales growth in Q1 2026, exceeding internal projections and reflecting accelerating physician adoption. - A new case study demonstrates how the noninvasive test helped avoid unnecessary biopsy in a 79-year-old patient with a suspicious lung nodule, with follow-up imaging confirming the test's negative result. - The flow cytometry and AI-based diagnostic addresses a growing market projected to reach $3.58 billion for pulmonary nodule management and lung cancer survivor surveillance. - CyPath Lung has demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients with small indeterminate nodules less than 20 millimeters.
- bioAffinity Technologies received patent approvals in China and Canada for its CyPath Lung diagnostic platform, which uses flow cytometry analysis of sputum to detect lung cancer. - The CyPath Lung test demonstrates 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small nodules less than 20 millimeters. - China represents a significant market opportunity with over 300 million smokers and 1.06 million new lung cancer cases diagnosed in 2022, while Canada sees approximately 31,000 new cases annually. - The patents protect the use of defined antibodies and porphyrin TCPP to label cell populations in sputum, strengthening the company's global intellectual property portfolio.
- BioAffinity Technologies received a U.S. patent for a novel cancer therapy that uses small interfering RNAs to simultaneously target CD320 and LRP2 receptors on cancer cell membranes. - In vitro studies demonstrated that dual knockdown of both proteins selectively kills human cancer cells while sparing normal cells, with applications across lung, breast, prostate, brain, and skin cancers. - The company has initiated research toward developing a topical treatment for skin cancers, marking a significant advancement in their therapeutic pipeline and intellectual property portfolio.
- bioAffinity Technologies has successfully closed a $3.25 million offering, issuing over 10 million shares of common stock along with warrants to purchase additional shares at $0.32 per unit. - The biotechnology company, listed on NASDAQ as BIAF, is focused on developing noninvasive tests for early-stage cancer detection, with their CyPath® Lung technology being a key product in their portfolio. - WallachBeth Capital served as the sole placement agent for the offering, which was completed on May 7, 2025, following SEC registration and approval.
- bioAffinity Technologies released clinical evidence showing CyPath® Lung's effectiveness in diagnosing early-stage lung cancer through real-world case studies authored by Dr. Gordon Downie. - The noninvasive sputum-based test successfully detected a second primary lung cancer in a high-risk patient with previous lung cancer history, facilitating timely treatment decisions. - Clinical studies demonstrate CyPath® Lung achieves 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small nodules. - Economic analysis suggests potential healthcare cost savings of $2,773 per Medicare patient and $6,460 per private-payer patient when integrated into standard lung cancer screening protocols.
