Full Press Release Details
Technologies Announces Acceptance of Australian Patent Application for Platform to Detect and Characterize Multiple Lung Diseases
patent strengthens global patent portfolio
ANTONIO, TX - October 28, 2025 - bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company
advancing early-stage diagnostics including CyPath Lung, the Company's noninvasive test for lung cancer, today announced
that the Australian Patent Office (IP Australia) has accepted a patent application for the Company's proprietary platform technology
for assessing lung health and predicting the likelihood of multiple lung diseases in patients.
accepted patent application underscores the broad potential of our technology to improve the diagnosis and management of lung disease,"
said Maria Zannes, President and CEO of bioAffinity Technologies. "The invention behind this patent uses our flow cytometry platform
to reveal disease-related changes across multiple cell types in a sputum sample. We believe this innovation can lead to a new generation
of diagnostic tools for personalized lung health."
patent application AU 2019253111, titled "System and Method for Determining Lung Health," covers methods that use
flow cytometry combined with fluorescent probes, molecular "tags" that attach to specific cell types, to detect cellular
and molecular signatures of multiple lung diseases.
flagship product, CyPath Lung, remains the centerpiece of the Company's commercial efforts, providing physicians with a noninvasive
tool to assess lung nodules detected by low-dose CT scans and incidental imaging.
Australian patent complements bioAffinity's existing intellectual property protection in the United States and other international
jurisdictions. Together, these patents safeguard the core technology that powers the CyPath Lung test and other diagnostics in 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. Until then, bioAffinity's
expanding global patent estate includes 18 awarded and 33 pending patents. The Company holds patents in the U.S., Australia, Canada,
China, France, Germany, Hong Kong, Italy, Japan, Mexico, Spain, Sweden and the United Kingdom.
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.
bioAffinity Technologies, Inc.
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.
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. Important factors that could cause actual results to differ materially from current expectations include,
among others, the benefits to be derived from the patent if issued, the Company's ability to safeguard its intellectual property,
the invention's ability of CyPath Lung to identify multiple diseases of the lung, and the other factors discussed in the Company's
Annual Report on Form 10-K for the year ended December 31, 2024, 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.