bioAffinity Technologies Announces Acceptance of Patent Application for Early-Stage Lung Cancer Diagnostic

bioAffinity Technologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com

Investor Relations
Dave Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447) or 407-491-4498
BIAF@redchip.com

bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage lung cancer and other lung diseases, today announced that the Australian Patent Office (IP Australia), has accepted bioAffinity’s patent application for the method of predicting the likelihood of lung cancer used by the CyPath^® Lung diagnostic test for early-stage lung cancer.

The Australian patent application, titled “Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning,” will be an important addition to bioAffinity Technologies’ patent portfolio, which includes 17 awarded U.S. and foreign patents and 38 pending patent applications related to its diagnostic platform and cancer treatment therapeutics. Once issued, the Australian patent will expire in 2042 and will be the second awarded for the CyPath^® Lung flow cytometry test as a stand-alone assay for the detection of lung cancer.

“Lung cancer is a global problem that requires global solutions like our noninvasive diagnostic CyPath^® Lung that detects the leading cancer-killer at early stage when treatment can lead to cures. The Australian patent is another milestone that increases our market and strengthens our potential to improve the outcome for lung cancer patients around the globe through earlier detection,” bioAffinity Technologies President and CEO Maria Zannes said. “Strong intellectual property protection for CyPath^® Lung benefits not only patients and their physicians, but also our shareholders and our Company.”

The Australia patent will be automatically issued three months after the acceptance date unless a third party files an opposition and proves to IP Australia why the patent should not be issued.

About CyPath^® Lung

CyPath^® Lung uses proprietary 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. CyPath^® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath^® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. 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. 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 based upon current estimates and assumptions and include statements regarding the Australian patent being an important addition to bioAffinity Technologies’ patent portfolio. 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, a third party filing an opposition to the automatic granting of the patent 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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