bioAffinity Technologies, Inc. will sponsor a Learning Theater presentation at CHEST 2026 on October 21, 2026, about CyPath Lung’s role in lung cancer risk stratification and pulmonary nodule management. Chief Medical Officer Gordon H. Downie, MD, PhD, will present clinical cases addressing predictive-model limitations and the lung microenvironment.
The release also discusses preliminary research into an investigational test for asthma- and COPD-related lung inflammation, which is not available for clinical use, and says the company’s Medical and Scientific Advisory Board will meet on its scientific and clinical programs. A published trial involving high-risk patients with small indeterminate nodules less than 20 millimeters reported 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value for CyPath Lung.
bioAffinity Technologies, Inc. (BIAF) announced it will present research at CHEST 2026 on sputum-based tests in development to characterize lung inflammation and detect protein biomarkers, including biologic drug targets associated with asthma and COPD. The research reports detection of multiple targets using cellular and proteomic analysis, with a workflow based on the flow cytometry and AI platform used by the company’s commercially available CyPath Lung diagnostic.
The sputum-based tests are investigational, have not been validated or cleared or approved by the FDA, and are not available for clinical or diagnostic use. The company said further research and validation would be needed before the approach could potentially help identify or monitor patients for specific therapies. References to named drugs identify research targets and are not a claim that the tests guide their use.
bioAffinity Technologies, Inc. (BIAF) closed a registered direct offering, priced at-the-market under Nasdaq rules, and a concurrent private placement on October 9, 2026. The registered sale comprised 116,545 common shares at $6.122 each and pre-funded warrants for up to 536,836 shares at $6.115 each, with a $0.007 exercise price per share. Gross proceeds were approximately $4 million before fees and expenses.
The concurrent private placement included unregistered warrants to purchase up to 980,072 common shares at $6.122 per share, exercisable commencing upon stockholder approval for five years from that date. Exercise is subject to a 4.99% beneficial-ownership limit, waivable up to 9.99% with at least 61 days’ notice. The company agreed to pay placement agent WallachBeth Capital LLC a cash fee equal to 7.5% of gross proceeds, issue warrants to purchase up to 19,602 shares, and pay $70,000 for legal-counsel fees and other out-of-pocket expenses. Net proceeds are intended for working capital, support for expected growing CyPath® Lung sales, and general corporate purposes. BIAF suspended use of the prospectus supplement and related prospectus for its ATM agreement; no sales may occur unless and until a new prospectus supplement is filed, and the agreement remains in effect.
bioAffinity Technologies (BIAF) is offering 116,545 common shares and up to 536,836 pre-funded warrants; the supplement also registers 536,836 underlying shares. Each pre-funded warrant sold reduces common shares offered one-for-one. The share price is $6.122; each pre-funded warrant costs $6.115 and has a $0.007 exercise price. They are immediately exercisable, subject to a 4.99% beneficial-ownership limit or 9.99% at a holder’s election.
The company intends net proceeds for working capital and general corporate purposes, including laboratory test and therapeutic product development, general and administrative matters, and capital expenditures. It states immediate net tangible book value dilution to common-share purchasers of $1.32 per share. Separately, it is selling up to 980,072 unregistered warrants in a concurrent private placement, exercisable at $6.122 per share beginning on stockholder approval and for five years thereafter. Audited statements for the years ended December 31, 2025 and December 31, 2024 include an explanatory paragraph citing conditions that raise substantial doubt about the company’s ability to continue as a going concern.
bioAffinity Technologies, Inc. (BIAF) reduced to $0 the dollar amount of common stock it may sell under its at-the-market agreement with WallachBeth Capital LLC. From and after October 8, 2026, it may not offer or sell shares under that agreement; it may file a further supplement to increase the amount if its capacity under General Instruction I.B.6 of Form S-3 increases. During the prior twelve-calendar-month period ending on and including the supplement date, the company offered and sold $1,800,000 of common stock under that instruction. While non-affiliate market value is less than $75,000,000, sales under the instruction are limited to one-third of aggregate market value in any 12-month period; reported non-affiliate market value was approximately $17,707,550 as of October 8, 2026.
bioAffinity Technologies, Inc. said the Japan Patent Office issued a Notice of Allowance indicating its intention to grant a patent for a method of predicting lung cancer likelihood powered by CyPath Lung. The patent is expected to issue after payment of the applicable issuance fee. If issued, it would be the first Japanese patent for CyPath Lung’s AI-built algorithm and the fifth patent protecting the company’s early lung cancer test in Asia, including China and Hong Kong. CyPath Lung uses flow cytometry and artificial intelligence to assess indeterminate pulmonary nodules in patients at high risk for lung cancer. It is marketed as a Laboratory Developed Test and is not intended for use as a sole diagnostic tool.
bioAffinity Technologies, Inc. (BIAF) reported that sales of its CyPath Lung test increased more than 100% through Q3 2026 compared with 2025. In Q3 2026, ordering physicians increased 89% year over year; physicians who ordered the test through Q3 2025 increased usage, with sales volume up 48% year over year. More than 1,620 tests were delivered through Q3 2026, compared with 775 through Q3 2025.
CyPath Lung is a noninvasive test for assessing lung cancer likelihood in high-risk individuals, with results considered alongside other clinical information. In a published clinical trial of high-risk patients with small indeterminate lung nodules less than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value. bioAffinity said its distribution agreement with Veteran-Owned AvMEDICAL could broaden access in government healthcare, including the Department of Veterans Affairs.
bioAffinity Technologies, Inc. (BIAF) and federal healthcare distribution partner AvMEDICAL held their first joint exhibition of CyPath Lung under their nationwide distribution agreement, presenting the test to more than 300 physicians, healthcare professionals and VA leaders at the NAVREF Annual Conference in Arlington, Virginia. The agreement is intended to expand government and agency access to CyPath Lung through AvMEDICAL’s procurement channels and government healthcare relationships.
The VA reports approximately 7,700 veterans are diagnosed with lung cancer each year. bioAffinity also presented CyPath Lung at the GO2 for Lung Cancer conference in San Diego; GO2 works with the VA and has a network of more than 700 screening centers of excellence. CyPath Lung analyzes cells in a noninvasive sputum sample using flow cytometry and proprietary AI, and is marketed as a Laboratory Developed Test.
bioAffinity Technologies, Inc. (BIAF) reported that it will present two posters on its noninvasive lung cancer diagnostic, CyPath® Lung, at the 2026 NAVREF Annual Conference, focusing on clinical use and ongoing research in veteran and military populations, together with new distribution partner AvMEDICAL.
One poster discusses complex high-risk cases where CyPath Lung was used alongside imaging and other tests, while a second describes the ongoing 2,000-patient FlowPath™ Lung longitudinal study across 12 VA medical centers and two major military hospitals. The company highlights previously reported CyPath Lung performance in patients with pulmonary nodules of 20 mm or less, including 92% sensitivity, 87% specificity and 99% negative predictive value, and cites an independent economic analysis suggesting its test has the potential to generate substantial per-patient and overall healthcare cost savings in lung cancer screening and diagnosis.
bioAffinity Technologies, Inc. (BIAF) reports that the Hong Kong Intellectual Property Department has granted a patent for its proprietary technology used to predict the likelihood of lung cancer by applying flow cytometry and fluorescent markers to characterize cell populations in sputum. Hong Kong Patent No. HK40048460, titled “System and Method for Determining Lung Health”, covers the use of defined antibodies and the porphyrin TCPP to label sputum cell populations and detect lung cancer cells via flow cytometry. This patent builds on a 2025 patent granted in China and contributes to a broader patent estate that includes multiple patents and pending applications in the United States, Australia, Canada, China, the European Union, Japan, Mexico and Singapore, supporting the CyPath® Lung diagnostic and other pipeline tests. The company highlights CyPath Lung’s noninvasive use in high-risk patients with small indeterminate lung nodules and cites published clinical trial results showing 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in detecting lung cancer.