bioAffinity Tech Stock Price, News & Analysis

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 (BIAF) announced that President and CEO Maria Zannes has been appointed to the American Lung Association in Texas' Leadership Board. In this role, Zannes will support the Lung Association's mission to prevent lung disease and promote lung health through research, education, and advocacy. As bioAffinity's CEO, Zannes leads a team developing noninvasive diagnostic tests, including CyPath® Lung for lung cancer detection, and tests for asthma and COPD. Charlotte Maffia, Executive Director of the American Lung Association in Texas, welcomed Zannes, citing her business experience and commitment to improving lung cancer patient outcomes as valuable assets to the organization.

bioAffinity Technologies has partnered with Cardinal Health OptiFreight Logistics to enhance the delivery and logistics of their CyPath Lung cancer detection test. The collaboration leverages OptiFreight's TotalVue Insights platform for shipment tracking and analytics to ensure reliable delivery of sputum samples to bioAffinity's laboratory. The partnership is particularly crucial as CyPath Lung expands its availability, including to veterans in rural areas through Federal Supply Schedule and GSA Advantage. The logistics solution provides real-time alerts for weather disruptions and processing delays, allowing the lab to adjust collection schedules and maintain efficient operations.

bioAffinity Technologies (BIAF) has secured a new U.S. patent (No. 12,305,171) for a novel cancer therapeutic approach targeting CD320 and LRP2 cell receptors. The technology uses small interfering RNAs (siRNAs) to selectively kill cancer cells while sparing normal cells. The patent covers applications for lung, breast, prostate, brain, and skin cancers, with initial research focusing on developing a topical treatment for skin cancer. This addition brings bioAffinity's portfolio to 19 awarded patents and 36 pending applications. In vitro studies demonstrated that simultaneous knockdown of both CD320 and LRP2 proteins is necessary for effective cancer cell elimination, as targeting only one receptor leads to increased expression in the other.

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.

bioAffinity Technologies (NASDAQ: BIAF) reported strong Q1 2025 financial results, highlighting 276% year-over-year growth in CyPath® Lung sales. The company generated revenue of $1.9 million and implemented strategic cost-reduction measures expected to save $3.8 million annually. Notable operational improvements increased test throughput by 50% while reducing unit costs by 25%. However, the company reported a net loss of $2.7 million ($0.16 per share), compared to a $2.0 million loss in Q1 2024. Cash position stood at $0.4 million as of March 31, 2025, though the company subsequently raised $4.7 million through warrant exercises and a public offering. The quarter saw expansion of CyPath® Lung's commercial footprint, strengthened international IP protection, and positive real-world clinical validations.