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) will present a corporate update and host one-on-one investor meetings at the H.C. Wainwright 28th Annual Global Investment Conference, held September 14-16, 2026.
President and CEO Maria Zannes will discuss recent and upcoming strategic milestones, commercial adoption of the CyPath® Lung diagnostic test, and development of additional diagnostic and therapeutic applications. Institutional investors can attend virtually or in person at the Lotte New York Palace Hotel, with meetings requested via the conference website. A live and archived webcast of the presentation will be available on September 11 at the provided link.
bioAffinity Technologies (Nasdaq: BIAF) is advancing the potential use of its noninvasive CyPath® Lung test for surveillance of lung cancer survivors who have completed curative-intent treatment. The company highlights that more than 680,000 Americans live with a prior lung cancer diagnosis, creating a large population requiring ongoing monitoring for recurrence and new cancers.
CyPath Lung analyzes sputum using flow cytometry, AI and a fluorescent porphyrin to identify malignancy-associated cells, providing a binary result of unlikely or likely malignancy that can complement CT imaging when new or changing pulmonary nodules are detected. In a published clinical trial in high-risk patients with small indeterminate nodules, CyPath Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value for early lung cancer detection. According to bioAffinity Technologies, these data support its current detection use; separate validation for post-treatment surveillance has not yet been completed.
bioAffinity Technologies (NASDAQ: BIAF) will implement a 1-for-15 reverse stock split of its common stock, effective at the open of trading on the Nasdaq Capital Market on August 24, 2026. Post-split shares will continue trading under the symbol BIAF with new CUSIP 09076W406.
Every 15 issued and outstanding shares will be exchanged for one share, with cash paid in lieu of fractional shares. According to the company, approximately 592,373 common shares will be outstanding immediately after the split, which is primarily intended to bring the company into compliance with Nasdaq’s minimum bid price requirement. Options and warrants will be adjusted proportionately, and VStock Transfer will act as exchange agent.
bioAffinity Technologies (Nasdaq: BIAF) announced a nationwide distribution agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business and established federal medical supplier, to commercialize its CyPath® Lung diagnostic test across U.S. government healthcare systems.
The deal leverages AvMEDICAL’s existing national sales force, IDIQ contracts, and procurement channels to promote CyPath Lung to federal customers, including Department of Veterans Affairs medical centers. Co-branded marketing will support outreach, and the agreement creates an additional channel for veterans to access the noninvasive test, which is performed by wholly owned subsidiary Precision Pathology Laboratory Services.
bioAffinity Technologies (Nasdaq: BIAF) closed a previously announced private placement of pre-funded warrants, priced at-the-market under Nasdaq rules, to purchase an aggregate of 8,462,027 shares of common stock. Each pre-funded warrant and accompanying two warrants has a combined effective offering price of $0.4657.
The pre-funded warrants have an exercise price of $0.007 per share. The accompanying warrants have an initial exercise price of $0.4727 per share, become exercisable following stockholder approval, and expire five years from issuance. According to bioAffinity, gross proceeds are estimated at $4.0 million before fees, and the company will provide customary registration rights for the underlying shares.
bioAffinity Technologies (Nasdaq: BIAF) closed its previously announced private placement of pre-funded warrants to purchase an aggregate of 8,462,027 common shares, priced at-the-market under Nasdaq rules. The combined effective offering price per pre-funded warrant and accompanying two warrants is $0.4657, generating estimated gross proceeds of $4.0 million before fees and expenses.
The pre-funded warrants have an exercise price of $0.007 per share. The accompanying warrants have an initial exercise price of $0.4727 per share, will be exercisable following stockholder approval, and will expire five years from issuance. The securities were issued in a private placement under Section 4(a)(2) and/or Regulation D, with customary registration rights for the underlying shares.
bioAffinity Technologies (Nasdaq: BIAF) entered a securities purchase agreement with an institutional investor to raise an estimated $4.0 million in gross proceeds through a private placement priced at-the-market under Nasdaq rules. The company will sell 8,462,027 shares of common stock (or pre-funded warrants in lieu thereof), together with two warrants to purchase up to an aggregate 16,924,054 shares of common stock.
The combined effective offering price is $0.4727 per share plus accompanying warrants, or $0.4657 per pre-funded warrant plus accompanying warrants. Pre-funded warrants have a $0.007 exercise price. The additional warrants carry a $0.4727 exercise price, are exercisable following stockholder approval, and expire five years after issuance. Closing is expected on or about August 14, 2026, subject to customary conditions. WallachBeth Capital is acting as sole placement agent. The unregistered securities are offered under Section 4(a)(2) and/or Regulation D, and the company will provide customary registration rights for shares underlying the warrants.
bioAffinity Technologies (Nasdaq: BIAF) entered into a securities purchase agreement with an institutional investor for a private placement priced at-the-market under Nasdaq rules. The company will sell 8,462,027 shares of common stock (or pre-funded warrants in lieu) together with two warrants to purchase up to an aggregate 16,924,054 shares of common stock.
The combined effective offering price is $0.4727 per share and accompanying warrants, or $0.4657 per pre-funded warrant and accompanying warrants. Pre-funded warrants have a $0.007 exercise price per share. The warrants carry a $0.4727 exercise price, become exercisable after stockholder approval, and expire five years from issuance. Gross proceeds are estimated at approximately $4.0 million before fees, with closing expected on or about August 14, 2026, subject to customary conditions. The securities are being issued in a private placement under Section 4(a)(2) and/or Regulation D, and the company will provide customary registration rights for shares underlying the warrants.
bioAffinity Technologies (Nasdaq: BIAF) reported Q2 2026 revenue of $1.51 million, up 19% year over year, driven mainly by higher CyPath® Lung sales, while net loss narrowed to $3.37 million from $4.06 million. CyPath Lung test volume rose 216% in Q2, with 1,097 test reports delivered in the first half of 2026 versus 390 a year earlier, and testing revenue for the period increased 159% to about $835,000.
The company expanded physician adoption, with ordering sites up 122% in Q2 and existing clients increasing orders 71% year over year. A longitudinal CyPath Lung clinical trial began enrollment at 11 sites with support from the John P. Murtha Cancer Center Research Program. bioAffinity also advanced diagnostics for asthma and COPD, reported positive preclinical data for topical siRNA-based skin cancer therapeutics, received a key Mexican patent allowance, and completed a June 2026 public offering generating approximately $3.2 million in gross proceeds. Cash and equivalents were $2.43 million at June 30, 2026.
bioAffinity Technologies (Nasdaq: BIAF) announced publication of a comprehensive clinical review and white paper by Chief Medical Officer Gordon H. Downie, MD, PhD, outlining a practical framework for integrating CyPath® Lung into pulmonary nodule evaluation and lung cancer surveillance across primary care, pulmonology and oncology.
The paper addresses the rising volume of pulmonary nodules driven by expanded screening, incidental findings and AI detection, and the need for improved risk stratification. It describes how CyPath Lung, a noninvasive sputum-based test that evaluates the lung microenvironment, has shown consistent clinical performance over three years of commercial use in helping physicians stratify malignancy risk, complement imaging and predictive models, and clarify challenging cases.
The framework proposes specialty-specific clinical pathways that incorporate CyPath Lung as an adjunct data point rather than a stand‑alone tool, emphasizing that direct analysis of sputum can reveal local immune responses, inflammation, genetic alterations and tumor biology not captured by blood-based diagnostics.