bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease and topically delivered therapeutics for skin cancer, today announced that a record number of CyPath® Lung tests were performed in October 2026, marking the highest monthly testing volume for the Company’s noninvasive lung cancer test.
The October results demonstrate continued growth in test utilization by both established and newly ordering physicians. In October 2026, 235 CyPath Lung tests were performed, representing a 29% increase compared with October 2025. October 2026 testing volume was equivalent to approximately 45% of the total number of tests performed in Q3 2026.
“October’s testing volume reflects our efforts to expand the commercial reach of CyPath Lung,” said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. “In addition to expanding physician adoption and strengthening relationships with existing customers, we are taking additional steps to expand the reach of CyPath Lung and set the stage for long-term growth. We have expanded our sales team. We are working with patient advocacy organizations to strengthen our connections within the lung cancer community, and we are seeing significant advances in our R&D to apply our proprietary technology platform to asthma and COPD.”
CyPath Lung is a noninvasive test that analyzes cell populations in sputum using flow cytometry and proprietary AI to help physicians assess the likelihood of lung cancer by analyzing the lung microenvironment. The test is designed to complement existing imaging and clinical assessment and provide physicians with additional information when determining appropriate next steps for patients.
bioAffinity continues to advance its commercial strategy through direct physician engagement, distribution relationships and opportunities within government healthcare systems. The Company is focused on increasing awareness and utilization of CyPath Lung among pulmonologists and other healthcare providers while building on its growing base of ordering physicians and repeat testing activity.
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 proprietary antibodies and a novel fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV may help inform physician decision-making when evaluating whether further invasive procedures are warranted. CyPath Lung is marketed as a Laboratory Developed Test (LDT), is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. For more information, visit www.cypathlung.com.
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 a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. 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 may identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially, including the Company’s ability to sustain physician demand and convert commercial efforts into reimbursable testing and revenue; variability in monthly testing volume; reimbursement coverage, payment rates, denials and collection delays; the ability to establish and maintain distribution relationships and obtain government healthcare business; and the possibility that research will not establish the clinical performance or utility needed for new applications or lead to commercially viable products. Historical testing volume does not establish future growth, revenue or profitability. Additional risks and uncertainties are described 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. Readers are cautioned not to place undue reliance on forward-looking statements. These statements speak only as of the date of this release, and the Company undertakes no obligation to update them, except as required by applicable law.
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