Case Demonstrates Benefit of Integrating
CyPath® Lung into Standard of Care for Patients Under Surveillance
After Treatment for Previous Lung Cancer
bioAffinity Technologies, Inc. (Nasdaq: BIAF;
BIAFW) today released a case study in which a positive CyPath®
Lung result led to the detection of a second primary lung cancer in
a high-risk patient who was previously diagnosed with stage 1A
non-small cell lung cancer and underwent successful surgery in
2023.
“The CyPath® Lung test provided real-time information that was
pivotal in identifying a second primary lung cancer, which might
have been missed with standard follow-up protocols,” bioAffinity
Technologies President and CEO Maria Zannes said. “This case
underscores the test's potential to significantly impact patient
outcomes by enabling early and accurate detection, especially when
imaging reveals small indeterminate nodules that would not
immediately lead to invasive diagnostic procedures.”
The patient is a 72-year-old with a 50 pack-year smoking history
and significant COPD and chronic respiratory failure who had a
wedge resection to remove a non-small cell lung cancer tumor.
Postoperative surveillance included regular computed tomography
(CT) scans that revealed changes in the scar tissue, raising
concerns about potential recurrence.
“Subtle changes post-op are common and present a diagnostic
dilemma. Due to her previous cancer diagnosis, serum markers were
contra-indicated, and a PET scan may be inconclusive on smaller
nodules,” said Gordon H. Downie, MD, PhD, Director of the Pulmonary
Nodule Clinic at Titus Regional Medical Center in Mount Pleasant,
Texas. “But now we have CyPath® Lung. Her CyPath® result came back
as likely cancer, which told me in real time that there were new
malignant cells in her lungs.”
Prompted by the CyPath® score, Dr. Downie ordered a PET scan
that revealed significant avidity in the mediastinum and right
hilum, along with a new nodule in the right upper lung. A
subsequent bronchoscopy confirmed a diagnosis of small cell
carcinoma, distinct from the initial NSCLC. This early detection
facilitated timely and appropriate treatment for the second primary
cancer.
“Each case study illustrates how CyPath® Lung provides
actionable information to the physician who can then move forward
in the best interest of each patient,” Ms. Zannes said. “By
providing earlier and more accurate diagnostic insights, CyPath®
Lung improves patient outcomes that can lead to lower healthcare
costs for both public and private insurers. We are seeing both
clinical and financial benefits with the broader adoption of
CyPath® Lung.”
A study published in the Journal of Health Economics Outcomes
and Research and authored by pulmonologists Michael Morris, MD, and
Sheila Habib, MD, found that an average cost savings of $2,773 per
patient would have been achieved in 2022 if CyPath® Lung had been
part of the standard of care for Medicare patients with a positive
lung cancer screening, for a total of $379 million. Adding CyPath®
Lung to the standard of care for private-payer patients with a
positive lung cancer screening result could have saved even more,
an average of $6,460 per patient, an estimated total savings of
$895 million if all individuals screened in 2022 were covered by
private insurance. The study attributes the savings to a reduction
in follow-up diagnostic assessments, expensive follow-up procedures
and procedure-related complications.
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 CyPath® Lung’s potential to
significantly impact patient outcomes by enabling early and
accurate detection, especially when imaging reveals small
indeterminate nodules that would not immediately lead to invasive
diagnostic procedures; and CyPath® Lung improving patient outcomes
that can lead to lower healthcare costs for both public and private
insurers with projected cost savings of $2,773 per Medicare patient
and $6,460 per private payer patient, an estimated total savings of
$895 million if all individuals screened in 2022 were covered by
private insurance. 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
significantly impact patient outcomes by enabling early and
accurate detection, increase diagnostic accuracy, lower healthcare
costs, 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. These forward-looking statements are
based upon current estimates and assumptions and include statements
regarding CyPath® Lung playing a crucial role in lung cancer
diagnostics and broader oncological decision-making, helping to
guide clinical strategies and improve patient outcomes while
reducing risky invasive procedures, and adding CyPath® Lung to the
standard of care for indeterminate nodules lowering healthcare
costs for both Medicare and private payers. 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 increase diagnostic accuracy, lower
healthcare costs, 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/20250326159613/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
bioAffinity Technologies (NASDAQ:BIAF)
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