bioAffinity Technologies Announces Acceptance of Patent Application for Early-Stage Lung Cancer Diagnostic
January 22 2025 - 7:00AM
Business Wire
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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version on businesswire.com: https://www.businesswire.com/news/home/20250122586375/en/
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
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