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bioAffinity Technologies Announces Notification of China Patent Award for Company's Noninvasive Lung Cancer Diagnostic Nearly one-third of world's smokers live in China, which has one of the highest rates of lung cancer

Key Takeaway: bioAffinity Technologies has received notification from the China National Intellectual Property Administration for the allowance of a patent related to its noninvasive lung cancer diagnostic method. This patent aims to enhance the company's strategy to expand its presence in the Chinese market, where lung cancer rates are notably high due to the large smoking population. The CyPath Lung test has shown strong clinical results, with high sensitivity and specificity in detecting early-stage lung cancer, which will potentially save lives in this underserved healthcare market.

Market Sentiment Analysis

POSITIVE FACTORS

  • Announcement of a patent allowance for noninvasive lung cancer diagnostic technology.
  • Significant market opportunity in China due to high number of smokers and lung cancer rates.
  • CyPath Lung demonstrates high sensitivity and specificity in clinical trials for early-stage lung cancer detection.

Full Press Release Details

bioAffinity Technologies Announces Notification
of China Patent Award
for Company's Noninvasive Lung Cancer Diagnostic
Nearly one-third of world's smokers live
in China, which has one of the highest rates of lung cancer
SAN ANTONIO, TX - July 15, 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 it has
received notification of allowance from the China National Intellectual Property Administration (CNIPA) for a patent application related
to methods of predicting the likelihood of lung cancer using flow cytometry.
China represents a large prospective market for CyPath
Lung with more than 300 million people who smoke, or nearly one-third of the world's total smokers, according to the World Health
Organization. The China cancer registry estimated 1.06 million new cases of lung cancer were diagnosed in 2022.
"This patent is another step forward in our strategy to safeguard
and expand the reach of our proprietary diagnostic platform internationally," said Maria Zannes, President and CEO of bioAffinity
Technologies. "With lung cancer representing a major health burden globally and particularly in China, we believe that securing
this intellectual property positions us well for future opportunities in one of the world's largest and most underserved healthcare
markets. It 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."
The newly allowed Chinese patent-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.
CyPath 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. In the study, CyPath
Lung detected all forms of lung cancer and 80% of cancers that were Stage 1.
This newly allowed patent complements bioAffinity's expanding global
patent estate, which now includes multiple patents in the U.S, China, Japan, Australia, Mexico, Canada and the EU.
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 benefits to be derived from the patent,
the Company's ability to safeguard its intellectual property, and the ability to market the CyPath Lung technology
in China. 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 derive benefits from the patent 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.
bioAffinity Technologies
Director of Communications
RedChip Companies Inc.
1-800-RED-CHIP (733-2447) or 407-491-4498

Frequently Asked Questions

What is CyPath Lung?

CyPath Lung is a noninvasive diagnostic test for early-stage lung cancer.

What recent achievement did bioAffinity Technologies announce?

They received a patent allowance from CNIPA for lung cancer diagnostic methods.

How effective is CyPath Lung in detecting cancer?

It shows 92% sensitivity, 87% specificity, and 88% accuracy for lung cancer detection.

Why is the Chinese patent significant for bioAffinity?

It enhances their intellectual property protection in a major healthcare market.

What technology does CyPath Lung utilize?

The test uses advanced flow cytometry and AI to identify cancerous cells.

Last updated: Jul 15, 2025