bioAffinity highlights 2,000-patient VA lung study
Rhea-AI Filing Summary
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.
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Filing Explained
The study is still enrolling, and the cited performance and savings remain limited or projected rather than established across broader use.
bioAffinity Technologies used this Form 8-K to report a planned September 27–30 conference presentation and an ongoing, currently enrolling 2,000-patient FlowPath™ Lung study across 12 VA medical centers and two military hospitals. The disclosure is informational: it does not report completed study results, a completed commercial transaction, or a change to existing common holders’ ownership.
The release presents prior performance figures of
The filing therefore adds a current enrollment status and conference milestone, while leaving the clinical study’s final performance and the economic impact of broader use unresolved.
8-K Event Classification
Key Figures
Key Terms
noninvasive lung cancer diagnostic medical
flow cytometry medical
negative predictive value medical
Laboratory Developed Test (LDT) regulatory
Clinical Laboratory Improvement Amendments (CLIA) regulatory
forward-looking statements regulatory
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did bioAffinity Technologies (BIAF) announce in this 8-K filing?
What is the FlowPath Lung study described by BIAF?
What performance metrics for CyPath Lung does BIAF report?
How many veterans are affected by lung cancer according to the BIAF disclosure?
What potential economic impact does BIAF reference for CyPath Lung?
How is CyPath Lung regulated and marketed according to BIAF?
What role will AvMEDICAL play in relation to BIAF’s CyPath Lung?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
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Item 8.01. Other Events.
On September 22, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that it is presenting two posters highlighting its noninvasive lung cancer diagnostic, CyPath® Lung, in clinical practice and ongoing research evaluating the technology in veteran and military populations at the 2026 NAVREF Annual Conference, September 27-30, 2026, in Arlington, Virginia.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
Description | |
| 99.1 | Press Release issued by bioAffinity Technologies, Inc., dated September 22, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |
| -2- |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: September 22, 2026 | BIOAFFINITY TECHNOLOGIES, INC. | |
| By: | /s/ Maria Zannes | |
| Name: | Maria Zannes | |
| Title: | President and Chief Executive Officer | |
| -3- |
Exhibit 99.1
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News Release |
bioAffinity Technologies to Present Positive Clinical and Veteran-Focused Data on CyPath® Lung at NAVREF 2026 Annual Conference
Presentations demonstrate beneficial role for CyPath Lung in veteran lung cancer care
NAVREF 2026 focuses on innovative research to improve healthcare for veterans
SAN ANTONIO, Texas – September 22, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, today announced it is presenting two posters highlighting its noninvasive lung cancer diagnostic, CyPath® Lung, in clinical practice and ongoing research evaluating the technology in veteran and military populations at the 2026 NAVREF Annual Conference, September 27-30, 2026, in Arlington, Virginia.
The National Association of Veterans’ Research and Education Foundations (NAVREF) Annual Conference brings together leaders from the Department of Veterans Affairs (VA), VA-affiliated research organizations, academia and industry working to improve healthcare and quality of life for veterans. bioAffinity Technologies is a member of NAVREF’s Industry Partner Consortium.
Representatives from bioAffinity Technologies and its new distribution partner, AvMEDICAL, will be available during the conference to discuss the potential healthcare benefits and commercial momentum of CyPath Lung. The NAVREF conference marks the first time that bioAffinity Technologies and AvMEDICAL will jointly engage with the federal healthcare market.
Lung cancer remains one of the most significant cancer challenges facing veterans. According to the VA, approximately 7,700 veterans are diagnosed with lung cancer each year. “The VA has made substantial progress in expanding lung cancer screening for veterans, which means a significant increase in the number of lung nodules that require careful evaluation,” said Maria Zannes, President and CEO of bioAffinity Technologies. “At the NAVREF conference we will share how CyPath Lung may benefit veterans by providing real-time information about lung nodules discovered by imaging.”
Poster #1: CyPath Lung in Practice
The first poster, “CyPath® Lung in Practice: From Uncertainty to Clarity and Confidence,” presents three clinical cases that involved atypical presentations and complex diagnostic considerations in high-risk patients with indeterminate pulmonary nodules.
CyPath Lung was used in conjunction with standard clinical evaluation, including low-dose CT, PET imaging, risk modeling and blood-based testing. The poster describes how incorporating CyPath Lung’s noninvasive flow cytometry + AI diagnostic into the clinical evaluation accelerated diagnosis, helped guide difficult clinical discussions and prevented unnecessary invasive procedures.
Poster #2: Longitudinal Study on Detection of Early-Stage Lung Cancer in Sputum
The second poster, “BA-004: Detection of Early-Stage Lung Cancer in Sputum using Flow Cytometry and an Automated Analysis Pipeline,” describes the ongoing FlowPath™ Lung study, a 2,000-patient longitudinal study designed to evaluate the clinical performance of the CyPath Lung flow cytometry test in veteran and military populations. The FlowPath Lung test is identical to the commercially available CyPath Lung test. The FlowPath Lung name is used exclusively for this research study.
The FlowPath Lung clinical study is currently enrolling patients. Veterans and military personnel from 12 VA medical centers and two of the nation’s largest military hospitals will participate in the clinical study. The John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is providing support and partial funding for the study.
The poster highlights CyPath Lung’s at-home sputum collection, which eliminates the need for patients to travel to a VA medical facility for specimen collection. It also presents CyPath Lung’s previously reported performance in patients with pulmonary nodules of 20 mm or less, including 92% sensitivity, 87% specificity and 99% negative predictive value. These results may not be indicative of performance in broader populations or different clinical settings. The poster summarizes the findings of an economic analysis published in 2024 by pulmonologists at Audie L. Murphy VA Medical Center and Brooke Army Medical Center who concluded that utilization of the bioAffinity’s test “has the potential to result in thousands of dollars per person and hundreds of millions of dollars overall in savings to health care associated with screening and diagnosis of lung cancer.”
About CyPath Lung
CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath Lung, is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential healthcare cost savings associated with screening and diagnosis of lung cancer using the Company’s technology. Any projections of cost savings or economic benefits are based on third-party analyses using assumptions that may not reflect actual clinical outcomes, reimbursement rates, utilization patterns, or healthcare system dynamics, and actual savings, if any, may differ materially from those projected. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to maintain regulatory approvals, the Company’s ability to achieve and maintain profitability, the outcome of ongoing and future clinical studies, uncertainties regarding the actual economic impact of the Company’s diagnostic technology in clinical practice, changes in healthcare reimbursement policies and payor coverage decisions, risks related to competition and technological changes in the biotechnology and diagnostics industries, the Company’s need for additional financing, risks related to government contracts and the federal procurement process, and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
Contact
bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com