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 (BIAF) closed a registered direct offering and concurrent private placement, raising approximately $4 million in gross proceeds.
An institutional investor purchased common stock at $6.122 per share or pre-funded warrants at $6.115 each, with a $0.007 exercise price. The private placement included warrants to purchase up to 980,072 shares at $6.122 per share. Those warrants become exercisable following stockholder approval and expire five years from that approval. WallachBeth Capital served as sole placement agent. bioAffinity intends to use net proceeds for working capital, support for expected growing CyPath Lung test sales, and general corporate purposes.
bioAffinity Technologies (NASDAQ: BIAF) closed a registered direct offering and concurrent private placement, raising approximately $4 million in gross proceeds. The institutional investor paid $6.122 per common share or $6.115 per pre-funded warrant, with a $0.007 exercise price for pre-funded warrants. The offering was priced at-the-market under Nasdaq rules.
The private placement included warrants to purchase up to 980,072 shares at $6.122 per share. These warrants become exercisable following stockholder approval and expire five years from that approval. Gross proceeds exclude placement agent fees and other offering expenses. The company intends to use net proceeds for working capital, supporting expected growing CyPath Lung sales, and general corporate purposes.
bioAffinity Technologies (NASDAQ: BIAF) entered a definitive agreement with an institutional investor for financing expected to raise approximately $4 million. The registered direct offering is priced at-the-market under Nasdaq rules, at $6.122 per common share or $6.115 per pre-funded warrant, which has a $0.007 exercise price.
A concurrent private placement includes warrants to purchase up to 980,072 shares at $6.122 per share. These warrants become exercisable following stockholder approval and expire five years from that approval. Closing is expected on or about October 9, 2026, subject to customary closing conditions. Expected gross proceeds exclude placement agent fees and other offering expenses. The company intends to use net proceeds for working capital, supporting expected growing sales of its CyPath Lung cancer test, and general corporate purposes. WallachBeth Capital is sole placement agent.
bioAffinity Technologies (NASDAQ: BIAF) entered a definitive agreement with an institutional investor for financing expected to raise approximately $4 million gross.
The registered direct offering is priced at $6.122 per common share or $6.115 per pre-funded warrant, with a $0.007 exercise price. A concurrent private placement includes warrants to purchase up to 980,072 shares at $6.122 each. Those warrants become exercisable following stockholder approval and expire five years from that approval. Closing is expected on or about October 9, 2026, subject to customary closing conditions. Gross proceeds exclude placement agent fees and other offering expenses. The company intends to use net proceeds for working capital, supporting expected growing CyPath Lung sales and general corporate purposes.
bioAffinity Technologies (Nasdaq: BIAF) received a Japanese patent allowance for the method of predicting lung cancer likelihood using CyPath Lung.
The application covers detection of early-stage lung cancer in sputum using automated flow cytometry, a cell-analysis method, and machine learning. The patent would be the first in Japan for CyPath Lung driven by an AI-built algorithm and the fifth protecting the test in Asia, including China and Hong Kong. Issuance is expected after payment of the applicable issuance fee. The company anticipates patents in additional geographic regions.
bioAffinity Technologies (BIAF) reported that CyPath Lung test sales increased more than 100% through the third quarter of 2026 compared with 2025. More than 1620 tests were delivered through Q3 2026, compared with 775 through Q3 2025. The number of ordering physicians increased 89% in Q3 2026 compared with Q3 2025. Physicians who ordered the test through Q3 2025 increased their sales volume by 48% year over year.
The company is focused on executing its new distribution agreement with Veteran-Owned AvMEDICAL, which it believes could broaden access within government healthcare, including the Department of Veterans Affairs. CyPath Lung assesses the likelihood of lung cancer in high-risk individuals; its results are intended to be considered alongside imaging, medical history, risk factors and clinical guidelines.
bioAffinity Technologies (Nasdaq: BIAF) debuted its federal distribution collaboration with AvMEDICAL by jointly exhibiting CyPath Lung to VA leaders and healthcare professionals.
The first joint exhibition under their new nationwide federal healthcare distribution agreement reached more than 300 physicians, healthcare professionals and VA leaders at the NAVREF Annual Conference in Arlington, Virginia. AvMEDICAL is a Service-Disabled Veteran-Owned Small Business. The agreement is intended to expand government and agency access to the noninvasive lung cancer test through AvMEDICAL’s procurement channels, contracting expertise and customer relationships.
bioAffinity also presented CyPath Lung at the GO2 for Lung Cancer screening and care conference in San Diego as part of its outreach to veterans and other patients at risk.
bioAffinity Technologies (BIAF) will present two posters on its CyPath® Lung diagnostic at the NAVREF 2026 Annual Conference from September 27-30, 2026, in Arlington, Virginia.
The first poster shares three complex clinical cases where CyPath Lung was used alongside standard tools such as low-dose CT, PET imaging, risk modeling and blood-based tests in high-risk patients with indeterminate pulmonary nodules. The company reports that integrating its noninvasive flow cytometry plus AI test accelerated diagnosis, guided difficult clinical discussions and helped avoid unnecessary invasive procedures. The second poster details the ongoing FlowPath™ Lung trial, a 2,000-patient longitudinal study of CyPath Lung in veteran and military populations across 12 VA medical centers and two large military hospitals.
The study highlights at-home sputum collection and cites previously reported performance in nodules ≤20 mm, with 92% sensitivity, 87% specificity and 99% negative predictive value, while noting these results may not extend to broader settings.
bioAffinity Technologies (BIAF) received a Hong Kong patent for its CyPath® Lung platform technology for noninvasive prediction of lung cancer using flow cytometry and fluorescent markers in sputum samples.
Hong Kong Patent No. HK40048460, titled “System and Method for Determining Lung Health,” covers use of defined antibodies and the fluorescent porphyrin TCPP to label sputum cell populations and identify lung cancer cells. This grant, alongside a 2025 China patent, strengthens the company’s intellectual property position in Asia, which has an estimated 1.6 million new lung cancer cases annually. CyPath Lung, built on this technology, is marketed as a Laboratory Developed Test and in a published trial showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in high-risk patients with small indeterminate nodules.
bioAffinity Technologies (BIAF) announced that it has regained compliance with Nasdaq listing requirements, ensuring continued trading of its common stock and warrants on the Nasdaq Capital Market.
Nasdaq confirmed on September 8, 2026 that the company now complies with Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share, and Listing Rule 5560(a), which governs listing standards for rights and warrants. As a result, the previously scheduled hearing before the Nasdaq Hearings Panel has been cancelled, and the company’s securities will continue to trade under the symbols BIAF for common stock and BIAFW for warrants, subject to ongoing compliance with all applicable Nasdaq listing requirements.