Full Press Release Details
Technologies Announces Notification of Mexico Patent Allowance Covering Novel Lung Cancer Detection Methods Using CyPath
intellectual property portfolio helps build shareholder value
strategy protects CyPath Lung's flow cytometry-driven diagnostic approach in international markets
ANTONIO, Texas - May 27, 2026 - 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 it has received notification of allowance from the Mexican Institute of Industrial Property
for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry.
issuance, the Mexican patent application will protect 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 sputum.
patent expands our global intellectual property portfolio and protection of CyPath Lung's proprietary approach
to detecting lung cancer at its earliest and most treatable stages," said Maria Zannes, President and CEO of bioAffinity Technologies.
"The integration of advanced cell biology, flow cytometry and AI into an easy-to-use, noninvasive test clearly differentiates our
technology, which is designed to support clinicians in evaluating indeterminate pulmonary nodules and high-risk patients."
Lung uses flow cytometry and artificial intelligence with at-home sample collection to assess indeterminate pulmonary nodules in high-risk
patients. Physicians are adding CyPath Lung to the clinical pathway to help risk stratify patients, reduce patient anxiety,
support surgical and treatment decision-making, and reduce overall healthcare costs.
patent further strengthens the Company's intellectual property (IP) portfolio supporting its flow cytometry-based CyPath
Lung diagnostic platform, which now includes multiple patents in the United States, the European Union, China, Japan, Australia, Canada
and Mexico. "Strong intellectual property protection for CyPath Lung benefits
not only patients and their physicians, but also supports value creation for our shareholders," Ms. Zannes said.
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 a 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 gives physicians greater confidence that
a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath
Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered
alongside other clinical findings.
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. LDTs are overseen under the Clinical
Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit
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 risk that pending patent applications may not result in issued patents, changes in the regulatory framework governing
Laboratory Developed Tests including potential increased FDA oversight, the Company's ability to successfully commercialize CyPath
Lung in domestic and international markets, the Company's ability to realize value from its international intellectual property
portfolio, the sufficiency of the Company's capital resources, and the other factors discussed 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. 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.