Sales of CyPath® Lung tests continue to
accelerate as sales team expands customer base of
pulmonology practices
bioAffinity Technologies, Inc. (Nasdaq: BIAF;
BIAFW), a biotechnology company focused on the need for
noninvasive tests for the detection of early-stage cancer, today
raised its full-year forecast for sales of CyPath® Lung in the
Company’s test marketing program by 85% and reported 217% growth in
second-quarter sales over first quarter 2024, outpacing the
forecast previously reported in May by 75%.
CyPath® Lung fulfills the need for a noninvasive test for the
early detection of lung cancer and is especially useful for
patients whose lung cancer screening or other scan reveals a
pulmonary nodule. The lung cancer diagnostics market is projected
to reach $4.7 billion by 2030, according to ReportLinker’s industry
analysis.
The accelerating growth of CyPath® Lung sales builds on the
foundation laid in 2023 when bioAffinity launched a strategic beta
marketing program in Texas after obtaining a CPT code and Medicare
reimbursement for CyPath® Lung. This initiative included hiring
seasoned sales executives to educate physicians on the benefits of
CyPath® Lung for patients at risk for lung cancer. Additionally,
private insurers have begun reimbursing for the test, which is
billed at $1,900 by Precision Pathology Laboratory Services (PPLS),
a wholly owned subsidiary of bioAffinity. PPLS is projected to
generate between $9.2 and $9.6 million revenue in 2024, including
sales of CyPath® Lung.
“We strategically focused our marketing efforts on our home
state of Texas as we launched CyPath® Lung, a noninvasive test that
has shown 92% sensitivity and 87% specificity in detecting cancer
in the lung for people who have pulmonary nodules 20 millimeters or
less,” bioAffinity Technologies President and CEO Maria Zannes
said. “The strategic decision to begin our commercial launch in
Texas allows us to hone our message, improve operations and prepare
for a broader market launch now scheduled for the fourth quarter of
2024.”
In the second quarter of 2024, physicians ordered 168 CyPath®
Lung tests. Based on the accelerating pace of test orders, the
Company has raised its forecast for 2024 CyPath® Lung sales to
exceed 880 tests. “In the fourth quarter of 2023, we processed 12
CyPath® Lung tests. That number increased to 53 tests in the first
quarter of 2024 and now 168 tests in the second quarter,” Ms.
Zannes said.
Texas represents the third largest market of critical care
pulmonologists in the nation, according to a November 2023 market
insight report by IQVIA Holdings Inc., a global provider of
advanced analytics, technology solutions, and clinical research
services to the life sciences industry. bioAffinity estimates Texas
physicians currently using CyPath® Lung for their patients at high
risk for lung cancer represent 10% of the Texas critical care
pulmonology market, and the expanded sales team is onboarding new
physicians weekly. Physicians in eight other states are ordering
CyPath® Lung after referrals from their peers who have incorporated
the test into their clinical practice, including pulmonologists in
New Jersey, Ohio, Pennsylvania, Michigan, North Carolina,
California, Florida and Arizona.
In addition to critical care pulmonologists who are considered
opinion leaders in advancing innovative lung cancer diagnostics
like CyPath® Lung, other physician specialties that may use the
test for their high-risk patients include general pulmonologists
and primary care physicians.
“Lung cancer screening and early diagnosis improve outcomes and
extend lives for patients at high risk for lung cancer. But imaging
is not always definitive, especially for pulmonary nodules smaller
than 20 millimeters,” Ms. Zannes said. “By combining the simplicity
of sputum as a biological sample with advanced flow cytometry and
automated analysis, CyPath® Lung gives physicians a valuable
diagnostic tool with high sensitivity and specificity for high-risk
patients, especially those with indeterminate nodules. And their
patients appreciate the user-friendly, noninvasive design of the
test.”
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 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 raising the full-year forecast for
sales of CyPath® Lung, PPLS generating between $9.2 and $9.6
million in revenue in 2024 including sales of CyPath® Lung, honing
the Company’s message, improving operations and preparing for a
broader CyPath® Lung market launch for the fourth quarter of 2024,
2024 CyPath® Lung sales exceeding 880 tests, Texas physicians
currently using CyPath® Lung for their patients at high risk for
lung cancer representing 10% of the Texas critical care pulmonology
market, the sales team onboarding new physicians weekly, other
physician specialties using the CyPath® Lung test for their
high-risk patients and the lung cancer diagnostics market reaching
$4.7 billion by 2030. 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 Company’s ability to
continue to accelerate the commercialization of CyPath® Lung and
capitalize on the lung cancer diagnostics market; the ability of
CyPath® Lung to provide the anticipated benefits to patients and
physicians; 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/20240709054084/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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