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.
Clinical Trials
5
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
2
40.0%
Not yet recruiting
1
20.0%
Recruiting
2
40.0%
No approval data available
- 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.
