bioAffinity Technologies Announces Publication of Results of Clinical Trial in Peer-Reviewed Journal Respiratory Research
January 24 2023 - 8:00AM
Business Wire
Noninvasive Test Developed Using Machine
Learning Detects Early-Stage Lung Cancer with High Sensitivity and
Specificity
bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) today
announced publication of “Detection of early-stage lung cancer in
sputum using automated flow cytometry and machine learning”
detailing results of the Company’s clinical trial for its
non-invasive diagnostic CyPath® Lung in Respiratory Research, one
of the leading peer-reviewed open access journals in the field of
respiratory medicine.
CyPath® Lung showed 92% sensitivity and 87%
specificity in high-risk patients who had nodules smaller than 20
millimeters or no nodules in the lung, with an area under the ROC
curve of 94%. Overall, the test resulted in specificity of 88% and
sensitivity of 82%, similar to far more invasive procedures
currently used to diagnose lung cancer. More than half of those in
the cancer cohort had early Stage I or II lung cancer. CyPath® Lung
detected multiple forms of cancer including adenocarcinoma,
squamous cell carcinoma and small cell lung cancer.
“The fact that CyPath® Lung can accurately predict lung cancer
at an early stage in patients with small nodules is particularly
important. Findings of lesions between six and 20 millimeters as a
result of lung cancer screening can lead to unnecessary invasive
procedures or a ‘watchful waiting’ period for patients,” said
Vivienne Rebel, MD, PhD, bioAffinity Chief Medical and Science
Officer and Executive Vice President. “Our test is intended for use
with patients who display these indeterminant nodules to increase
the accuracy of lung cancer screening and provide certainty for
patients and their physicians.”
“CyPath® Lung uses an automated flow-based approach combined
with machine learning that can be put into routine lab use without
requiring expert evaluation of samples or being subject to operator
bias,” said Madeleine Lemieux, PhD, who is first author and led
development of the automated analysis used in CyPath® Lung. “The
entire sample is rapidly analyzed which ensures maximal
sensitivity. The automated, numerical analysis captures complex
interactions between lung cancer and the micro-environment to
reliably predict the presence of lung cancer that would not be
possible for even expert individuals to do from visual flow
data.”
Before working with bioAffinity Technologies, Dr. Lemieux was a
computational biologist at the Dana Farber Institute and Harvard
Medical School. She has contributed to more than 40 publications
leveraging data from high-throughput platforms. Dr. Lemieux and Dr.
Rebel began their successful collaboration during their doctoral
studies.
CyPath® Lung uses flow cytometry, a method able to interrogate
individual cells in a fraction of a second, and automated analysis
to identify parameters in sputum that are indicative of cancer.
Unlike genomic or other molecular markers used in liquid biopsies,
bioAffinity’s CyPath® technology does not collect genetic material
for evaluation. Instead, CyPath® Lung analyzes the lung
micro-environment and identifies whole cell populations that
indicate cancer is present in the lung.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) addresses
the need for noninvasive detection of early-stage cancer and
diseases of the lung, and targeted cancer treatment. The Company’s
first product, CyPath® Lung, is a noninvasive test
that has shown high sensitivity and specificity for the detection
of early-stage lung cancer. CyPath® Lung is marketed as a
Laboratory Developed Test (LDT) by Precision Pathology Services.
OncoSelect Therapeutics, LLC, a subsidiary of bioAffinity
Technologies, is advancing its discoveries shown in vitro to kill
cancer cells without harm to normal cells. Research and
optimization of the Company’s platform technologies are conducted
in its laboratories at The University of Texas at San Antonio.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the anticipated use of proceeds from
the Company’s offering of common shares. Forward-looking statements
can be identified by words such as “believes,” “expects,”
“estimates,” “intends,” “may,” “plans,” “will” and similar
expressions, or the negative of these words. 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. Readers of this press release are cautioned not to
place undue reliance on any forward-looking statements. 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/20230124005372/en/
Company Contact: Julie Anne Overton, Director of
Communications jao@bioaffinitytech.com
Investor Relations Contact: Tiberend Strategic Advisors,
Inc. Jonathan Nugent jnugent@tiberend.com or David Irish
dirish@tiberend.com
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