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bioAffinity Technologies Reports Positive Results from Texas Beta Launch of CyPath® Lung

1. bioAffinity reported over 600 CyPath® Lung tests sold in 2024. 2. Sales growth is supported by addition to the U.S. Federal Supply Schedule. 3. CyPath® Lung shows 92% sensitivity and 87% specificity for early lung cancer detection. 4. Economic study estimates $895 million saved for privately insured patients with CyPath®. 5. Expansion into Veteran and military medical systems planned for 2025.

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FAQ

Why Bullish?

The sales growth and market expansion indicate strong future potential, similar to companies like Guardant Health post-FDA approval.

How important is it?

The successful pilot and planned military sales are significant for revenue growth, crucial for stock performance.

Why Long Term?

Sustained growth and market positioning suggest lasting impacts, similar to biotechnologies that establish new standards of care.

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BIAFGHDXEXAS
SAN ANTONIO--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, today reported the results of the Company’s CyPath® Lung pilot marketing program using Texas for our beta launch with sales of more than 600 tests delivered in 2024. “We are extremely pleased with the exponential growth and our 2024 achievements in delivering a quality diagnostic that makes a difference in patient care. We already see more and more physicians and pulmonary practices incorporating CyPath® Lung into their practices, and we are excited that this year we will launch sales to Veteran and military medical systems,” bioAffinity Technologies President and CEO Maria Zannes said. “The sales growth we saw quarter-over-quarter in 2024 is continuing in 2025 and is supported by the addition of CyPath® Lung to the U.S. Federal Supply Schedule (FSS), making the test available to Veterans and active military across the U.S. government health systems.” Ms. Zannes was recently featured on Nasdaq’s Amplify Spotlight, a series focused on leaders in the small-cap community, where she explained the unique attributes of CyPath® Lung and the strategy for expanding its position in the lung cancer diagnostics market. CyPath® Lung has shown 92% sensitivity and 87% specificity in high-risk patients who had nodules smaller than 20 millimeters. More than half of those in the cancer cohort had early Stage I or II lung cancer. CyPath® Lung detected multiple forms of cancer including adenocarcinoma, squamous cell carcinoma and small cell lung cancer. “In addition to the high sensitivity and specificity of CyPath Lung, physicians reported they were impressed by the findings of the peer-reviewed economic study by two prominent pulmonologists. This study demonstrated total savings of $379 million, or more than $2,700 per patient, would have resulted in 2022 had CyPath® Lung been the standard of care for Medicare patients,” Zannes said. “For patients with private insurance, the study concluded that savings would have been more than $6,400 per patient for total savings of more than $895 million.” Michael J. Morris, M.D., Brooke Army Medical Center (BAMC) pulmonology and critical care physician and Assistant Dean of Research at San Antonio Uniformed Services Health Education Consortium (SAUSHEC), and Sheila A. Habib, M.D., Director of the Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program at the South Texas Veterans Health Care Systems’ Audie L. Murphy Memorial Veterans Hospital were first and second authors on the study published in the Journal of Health Economics and Outcomes Research. “As more physicians order more CyPath® Lung tests for their patients, doctors are sharing their stories of early detection and the individual patients who are more likely to have a positive outcome despite a diagnosis of lung cancer,” Ms. Zannes said. “Needless to say, this is one of the most gratifying parts of the work we do, and we are looking forward to expanding our marketing effort working with our Key Opinion Leaders in 2025 to grow our market share and improve early diagnosis of lung cancer and provide peace of mind to patients at risk.” About CyPath® Lung CyPath® Lung uses advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and 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. Diagnosing and treating early-stage cancer can improve outcomes and increase patient survival. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and 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. Research and optimization of the Company’s platform technologies are conducted in its laboratories at Precision Pathology and The University of Texas at San Antonio. For more information, visit www.bioaffinitytech.com and follow us on LinkedIn, Facebook and X. 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 based upon current estimates and assumptions and include statements regarding continued sales growth in 2025, launching sales to Veteran and military medical systems in 2025, and looking forward to working with Key Opinion Leaders in 2025 to expand the Company’s market to improve early diagnosis of lung cancer and provide peace of mind to patients at risk. 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. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to continue sales growth in 2025 and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, 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.

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