CMS Posts Final Payment Determination for bioAffinity Technologies’ CyPath® Lung Effective January 2024
November 30 2023 - 8:00AM
Business Wire
bioAffinity Technologies, Inc. (Nasdaq: BIAF;
BIAFW), a biotechnology company addressing the need for
noninvasive detection of early-stage lung cancer and other lung
diseases, today announced that the Centers for Medicare and
Medicaid Services (CMS) has made a final determination for payment
for CyPath® Lung, a noninvasive test for early-stage lung cancer,
for the 2024 calendar year.
“CyPath® Lung, our noninvasive test for the detection of
early-stage lung cancer, is now on CMS’ 2024 clinical laboratory
fee schedule, a major milestone that facilitates reimbursement by
both Medicare and private payers, which in turn should make our
test even more attractive to both physicians and their patients at
high risk for lung cancer,” bioAffinity Technologies President and
CEO Maria Zannes said. “The CMS payment determination is an
important achievement in our strategic plan to ramp up the
commercialization of CyPath® Lung.”
Based on the Medicare Advisory Panel on Clinical Diagnostic
Laboratory Tests recommendation, CMS previously released a
preliminary payment decision for the Current Procedural Terminology
(CPT) code specific to CyPath® Lung. For the calendar year 2024
Medicare Clinical Lab Fee Schedule, CMS finalized the panel’s
recommendation for CyPath® Lung for purposes of payment by
Medicare. This payment information also serves as a reference for
private payers and other public health insurance programs.
In June 2023, the American Medical Association (AMA) issued the
CPT Proprietary Laboratory Analyses (PLA) code 0406U for CyPath®
Lung with the descriptor “Oncology (lung), flow cytometry, sputum,
5 markers (meso-tetra [4- carboxyphenyl] porphyrin [TCPP], CD206,
CD66b, CD3, CD19), algorithm reported as likelihood of lung
cancer.” CMS released a preliminary payment decision in September
2023, agreeing with the Medicare Advisory Panel’s recommendation.
In November 2023, CMS finalized the 2024 payment determination for
CPT 0406U, effective January 1, 2024.
Physicians can order CyPath® Lung from Precision Pathology
Laboratory Services, a subsidiary of bioAffinity Technologies.
CyPath® Lung, a laboratory developed test (LDT), uses flow
cytometry to identify cell populations in patient sputum that
indicate malignancy. Automated data analysis developed using
proprietary artificial intelligence can help determine if cancer is
present or if the patient is cancer-free. CyPath® Lung incorporates
a fluorescent porphyrin, TCPP, that is preferentially taken up by
cancer and cancer-related cells. In a clinical trial, CyPath® Lung
showed 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. Half of all
patients in the trial who had cancer were diagnosed in early Stages
I or II.
The discovery of small pulmonary nodules as part of annual lung
cancer screening using low dose computed tomography (LDCT) can be
problematic to diagnose. Patients may be asked to “wait and see” if
the next scan reveals the nodule has grown or proceed immediately
with invasive procedures, including biopsy, that may turn out to be
unnecessary. “Actionable results from CyPath® Lung may help doctors
and their patients determine appropriate next steps for suspected
cases of lung cancer,” Ms. Zannes said.
About bioAffinity Technologies, Inc. bioAffinity
Technologies, Inc. addresses the need for noninvasive diagnosis of
early-stage cancer and 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. Research and optimization of the Company’s platform
technologies are conducted in its laboratories at Precision
Pathology and The University of Texas at San Antonio. For more
information, visit www.bioaffinitytech.com and follow us on
LinkedIn, Facebook and X.
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 CMS’ 2024 clinical
laboratory fee schedule making the Company’s test even more
attractive to both physicians and their patients at high risk for
lung cancer and CyPath® Lung helping 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 to benefit from
the 2024 payment determination for CPT 0406U, 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/20231130362946/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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