AMA Issues CPT Code for bioAffinity Technologies’ CyPath® Lung Test for Early-Stage Lung Cancer
12 Luglio 2023 - 2:00PM
Business Wire
bioAffinity Technologies, Inc. (Nasdaq: BIAF;
BIAFW), a biotechnology company addressing the need for
noninvasive detection of early-stage lung cancer, today announced
that the American Medical Association (AMA) has released a Current
Procedural Terminology (CPT) code specifically for use with CyPath®
Lung, a noninvasive test for early-stage lung cancer.
Created and maintained by the AMA’s independent CPT Editorial
Panel, CPT codes provide a uniform system to identify medical
services and procedures and seek reimbursement from private payers
and public health insurance programs, including Medicare and
Medicaid. The reimbursement code for CyPath® Lung will be effective
Oct. 1, 2023.
“Our mission is to detect cancer at an early stage to improve
long-term survival. The AMA’s approval of a CPT code specific to
CyPath® Lung is an important milestone along that path,”
bioAffinity Technologies President and CEO Maria Zannes said. “We
believe the CPT code is recognition by clinical and industry
experts that our noninvasive test is an innovative addition to
current clinical practice for patients at high risk for developing
lung cancer.”
Marketed by Precision Pathology Services as a laboratory
developed test (LDT), CyPath® Lung uses flow cytometry and
automated analysis to profile patient sputum samples to reliably
predict the presence of lung cancer. CyPath® Lung incorporates a
fluorescent porphyrin, TCPP, that is preferentially taken up by
cancer and cancer-related cells. In a recent clinical trial,
CyPath® Lung showed 92% sensitivity and 87% specificity in
high-risk patients who had lung nodules smaller than 20
millimeters.
When a low dose computed tomography (LDCT) scan reveals nodules
smaller than 20 millimeters, doctors and patients may not have a
clear path forward. The common choices are to “wait and see” what
the next scan reveals or proceed with an invasive procedure,
including biopsy, that may turn out to be unnecessary.
“The AMA’s recognition of CyPath® Lung reflects the need for
noninvasive and accurate follow-up in patient care after lung
cancer screening,” Ms. Zannes said. “Actionable results from our
test will help doctors and their patients determine appropriate
next steps for suspected cases of lung cancer.”
The CyPath® Lung CPT code was approved as a Proprietary
Laboratory Analyses (PLA) code, which can be provided by a single
laboratory or licensed or marketed to multiple providing
laboratories. CyPath® Lung is currently available through Precision
Pathology Services, an accredited CAP/CLIA laboratory in San
Antonio, Texas.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for
noninvasive diagnosis 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. 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 detecting cancer at an early stage in
order to improve long-term survival, the AMA’s approval of a CPT
code specific to CyPath® Lung being recognition by clinical and
industry experts that the Company’s test is an innovative addition
to current clinical practice for patients at high risk for
developing lung cancer, and actionable results from the Company’s
test will help doctors and their patients determine appropriate
next steps for suspected cases of lung cancer. 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 the Company’s test to produce
actionable results to help doctors and their patients determine
appropriate next steps for suspected cases of lung cancer and the
other factors discussed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022, 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/20230712526323/en/
bioAffinity Technologies Julie Anne Overton Director of
Communications jao@bioaffinitytech.com
LHA Investor Relations Tirth T. Patel tpatel@lhai.com
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