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bioAffinity Technologies Announces Initiation of Large-Scale Longitudinal Clinical Study for Its Noninvasive CyPath Lung Cancer Diagnostic Study to evaluate clinical performance of CyPath Lung for the early detection of

Key Takeaway: bioAffinity Technologies, Inc. has announced the initiation of a large-scale longitudinal clinical study aimed at evaluating the effectiveness of its noninvasive diagnostic test, CyPath Lung, for early-stage lung cancer detection. The study will involve 2,000 high-risk patients and is supported by major medical institutions including the Murtha Cancer Center. Past trials have shown promising results with high sensitivity and specificity. The objective is to establish CyPath Lung as part of the standard care for lung cancer screening and diagnosis.

Market Sentiment Analysis

POSITIVE FACTORS

  • Initiation of a large-scale clinical study for CyPath Lung.
  • High sensitivity (92%), specificity (87%), and accuracy (88%) demonstrated in earlier trials.
  • Collaboration with prestigious institutions like the Murtha Cancer Center and VA medical centers.
  • Potential to fill diagnostic gaps for early detection of lung cancer.

CONCERNS & RISKS

  • Risks associated with patient recruitment and retention during the study.
  • Possibility that study results may not demonstrate anticipated performance or clinical utility.
  • Challenges in gaining clinician and patient adoption for the CyPath Lung test.

Full Press Release Details

bioAffinity Technologies Announces Initiation
of Large-Scale Longitudinal Clinical Study for Its Noninvasive CyPath Lung Cancer Diagnostic
Study to evaluate clinical performance of
CyPath Lung for the early detection of lung cancer in high-risk patients
Murtha Cancer Center Research Program at
Uniformed Services University of the Health Sciences provides support for longitudinal study
ANTONIO, TX - March 10, 2026 - bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused
on non-invasive diagnostics and early cancer detection, today announced initiation of the Company's planned large-scale, longitudinal
clinical study for CyPath Lung, its noninvasive diagnostic test for the detection of early-stage lung cancer.
The 2,000-patient longitudinal study is designed
to evaluate the clinical performance of the CyPath Lung flow cytometry test as a noninvasive diagnostic that uses sputum samples
to detect the presence of lung cancer in high-risk individuals with existing lung nodules six millimeters (mm) to less than 30 mm in
diameter identified by lung cancer screening. In an earlier clinical trial, CyPath Lung showed 92% sensitivity, 87% specificity
and 88% accuracy in detecting lung cancer in patients with small pulmonary nodules less than 20mm. Several recent patient case studies
demonstrate the test's ability to detect lung cancer at its curative Stage 1A.
bioAffinity Technologies expects up to 20 clinical study sites, including
a dozen Department of Veterans Affairs (VA) medical centers and two of the nation's largest military hospitals, will participate
in the study. Michael J. Morris, MD, pulmonology and critical care physician at Brooke Army Medical Center, is the national Principal
Investigator for the study (NCT07168993). The John P. Murtha Cancer Center Research Program (MCCRP),
a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland,
is providing support and funding associated with the trial at several federal facilities.
Physicians currently order CyPath Lung, a laboratory developed
test (LDT) offered by bioAffinity Technologies' subsidiary Precision Pathology Laboratory Services, for their patients with indeterminate
lung nodules to determine next steps in patient care.
The longitudinal clinical trial announced today will evaluate FlowPath
Lung, a research-use test that uses the same technology and follows the same procedures as CyPath Lung. The different name is simply
used to distinguish the investigational assay from the commercially available test.
"As more indeterminate pulmonary nodules are found either incidentally
or by routine lung cancer screening, CyPath Lung can fill the diagnostic gap between watchful waiting' and invasive
procedures that carry risk," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "As a result,
we see growing adoption and use of CyPath Lung by physicians and expect this longitudinal trial to provide additional evidence to
support inclusion of our noninvasive test as part of the standard of care for lung cancer screening and diagnosis."
"Initiating this study represents an important milestone for
CyPath Lung," said Maria Zannes, President and CEO of bioAffinity Technologies. "By following patients longitudinally
across multiple sites, we expect to acquire robust, real-world data that reflects how CyPath Lung may be used to support risk assessment
and clinical decision-making aligned with our objective to establish CyPath Lung as a standard of care for evaluating patients at
high-risk for early-stage lung cancer."
The study includes participation from several federal facilities to
examine the test's performance in diverse patient populations, including military service members and veterans. Patient enrollment is
expected to take up to 18 months with patients followed for up to 24 months or until a definitive diagnosis of cancer or no cancer is
CyPath Lung is a non-invasive
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.
Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at
high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the
need for non-invasive 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 non-invasive 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 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 ability of CyPath Lung to identify lung cancer in difficult-to-diagnose patients;
the benefits of adding CyPath Lung to the standard of care for evaluating indeterminate lung nodules; CyPath Lung providing
clarity when imaging and risk models are inconclusive; the ability to initiate and conduct the study as planned; challenges in patient
identification, enrollment, retention, and protocol adherence; site performance and operational execution; variability in study data and
outcomes; the possibility that study results do not demonstrate the anticipated performance or clinical utility; changes in standards
of care, competitive developments, or technological advances; delays or difficulties in obtaining, maintaining, or expanding regulatory
approvals or clearances; manufacturing, quality, supply chain, and scaling challenges; reimbursement and coverage uncertainties; the ability
to obtain clinician and patient adoption; and the 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

Frequently Asked Questions

What is the purpose of the CyPath Lung study?

The study aims to evaluate CyPath Lung's clinical performance for early lung cancer detection.

How many patients are involved in the CyPath Lung study?

The study will involve 2,000 high-risk patients with existing lung nodules.

What is the expected enrollment duration for patients?

Patient enrollment is anticipated to take up to 18 months.

What technology does CyPath Lung utilize?

CyPath Lung employs flow cytometry and AI to detect malignancy in sputum samples.

What were the sensitivity and specificity results of CyPath Lung?

CyPath Lung showed 92% sensitivity and 87% specificity in detecting lung cancer.

Last updated: Mar 10, 2026