Full Press Release Details
Awards New Patent to bioAffinity Technologies for CyPath Lung, Company's Noninvasive Lung Cancer Diagnostic
patent protects market expansion to the north where lung cancer is leading cause of cancer deaths
ANTONIO, TX - July 22, 2025 - bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing
early-stage cancer diagnostics including CyPath Lung, the Company's commercially available test for early-stage
lung cancer, today announced its patent related to a method to detect lung disease through flow cytometry analysis of sputum has been
allowed by the Canadian Patent Office. This patent strengthens the international protection of the Company's diagnostic platform
that powers its flagship test, CyPath Lung.
with the recent announcement of the award of our patent in China, this Canadian patent reflects our continued execution toward building
long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can
save lives," said Maria Zannes, President and CEO of bioAffinity Technologies.
cancer is the leading cause of cancer death in Canada, according to the Canadian Cancer Society. In 2024, approximately 31,000
Canadians were diagnosed with lung cancer, and approximately 20,700 people died of the disease. More than 70% of the lung cancer deaths
were linked to smoking.
believe that the award of this patent by the Canadian Patent Office further validates the diagnostic platform behind CyPath
Lung, expands the global footprint of our intellectual property portfolio and highlights the strength of our science," Ms. Zannes
said. "Recent case studies highlight CyPath Lung's ability to detect lung cancer at its earliest stages, making our test
all the more valuable in Canada where 50% of all lung cancer cases are diagnosed late at Stage IV with the five-year survival rate overall
of about 19% in Canada, according to government statistics."
Canadian patent (Patent No. 3,136,245) - titled "System and Method for Determining Lung Health" - protects the
use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence
of lung cancer cells in the sputum.
Lung is the Company's first commercial product, with clinical study results demonstrating 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.
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 based upon current estimates and assumptions and include statements
regarding the benefits to be derived from the patent, the Company's ability to safeguard its intellectual property, and the ability
to market CyPath Lung in Canada. 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, the Company's ability to safeguard
its intellectual property, and the ability to market CyPath Lung in Canada, and 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.
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