Transformative Strategic Transaction Supports
Commercialization of CyPath® Lung
Precision Pathology Founder Dr. Roby Joyce
Joins bioAffinity’s Board of Directors
Conference Call at 4:30 p.m. Eastern time
Today
bioAffinity Technologies, Inc. (Nasdaq: BIAF,
BIAFW), a biotechnology company addressing the need for
noninvasive detection of early-stage lung cancer, announces the
acquisition of the laboratory assets of Village Oaks Pathology
Services, P.A., d/b/a Precision Pathology Services, a clinical
laboratory accredited by the College of American Pathologists (CAP)
and certified under the Clinical Laboratory Improvement Amendments
(CLIA) of 1988. The laboratory assets are being acquired by a new
wholly owned subsidiary of bioAffinity Technologies, Precision
Pathology Laboratory Services, LLC (PPLS). bioAffinity Technologies
management will host a conference call today to discuss the
acquisition. Instructions for accessing the call can be found
below.
Precision Pathology provides pathology services to physicians
practicing in a variety of outpatient settings and has offered
bioAffinity Technologies’ CyPath® Lung as a laboratory developed
test for the detection of early-stage lung cancer. This transaction
gives bioAffinity the opportunity to build a commercial laboratory
with scale with the goals of accelerating the market uptake and
success of CyPath® Lung, supporting the test’s upcoming
1,800-patient FDA pivotal trial, and pursuing the development and
commercialization of additional tests. In addition to CyPath® Lung,
Precision Pathology offers a range of laboratory services including
respiratory testing for SARS-CoV-2 and influenza, anatomic
pathology, morphological stains, histological services, DNA
extractions, STI testing, and women’s and men’s health testing.
Precision Pathology was acquired for $3.5 million including $2.5
million in cash and $1.0 million in bioAffinity common stock.
“The acquisition of our partner laboratory Precision Pathology
supports and enhances bioAffinity’s commercial strategy by
integrating every aspect of CyPath® Lung, from manufacturing to
sales and marketing, and now to pathology services and reporting
results back to physicians. With core operations established over
the past 16 years and an unwavering commitment to quality and
customer service, Precision Pathology is precisely the asset
bioAffinity needs to build scale and efficiency to make CyPath®
Lung a strong success,” bioAffinity Technologies President and CEO
Maria Zannes said.
“Combining the ground-breaking innovation and expertise of both
companies supports the launch of our FDA pivotal trial for CyPath®
Lung and further advances our ability to develop additional
products, including a test for COPD. This consolidation also allows
bioAffinity to capture 100% of the revenues from the sale of
CyPath® Lung,” Ms. Zannes said. “Precision Pathology has earned an
excellent reputation across medical specialties and has been a
strong partner. We welcome our new colleagues to bioAffinity.”
Roby P. Joyce, M.D., who founded Precision Pathology in 2007,
will continue as medical director of PPLS and will join the
bioAffinity Technologies board of directors. In accordance with law
that requires a physician to own a medical professional
association, Dr. Joyce will retain ownership of Village Oaks
Pathology Services, the medical professional association whose
pathologists work with Precision Pathology. As part of the
transaction, bioAffinity Technologies has signed a management
services agreement with the association to provide staff, equipment
and administrative support for a fee with an initial term of 20
years.
“We have worked side by side with Maria and her team for the
past five years to bring CyPath® Lung to market, and I have been
consistently impressed by bioAffinity’s scientific team and
management. This acquisition represents a tremendous opportunity
for both organizations to create a stronger, more complete platform
to address unmet needs in cancer diagnostics,” Dr. Joyce said. “I
am particularly excited about CyPath® Lung because, as a physician,
I know that lung cancer is highly curable when detected early and
before it has spread. Supporting CyPath® Lung is among the most
important things I have done in my career, and I have no doubt that
this test will save many lives.”
Dr. Joyce is board-certified in anatomic and clinical pathology
by the American Board of Pathology and is a Fellow in the College
of American Pathologists. He is also board-certified in neurology
by the American Board of Psychiatry and Neurology (Neurology) and
is a Fellow in the American Academy of Neurology. In addition to
his role at Precision Pathology, he has served in various
capacities at Northeast Methodist Hospital in San Antonio,
including Chairman of the Board of Trustees from 1994-1995 and
Chief of Staff of the Methodist Healthcare System from 2005-2006.
Throughout a career in pathology that spans more than 40 years, he
has been a highly regarded speaker at medical and scientific
conferences, has served in leadership roles on dozens of
professional organizations and committees, and has served as lead
or co-author of numerous scientific articles.
Dr. Joyce received his medical degree from Louisiana State
University in New Orleans. He completed an internal medicine
internship at Fitzsimons Army Medical Center in Denver, his
residency in neurology at the Letterman Army Medical Center
Hospital in San Francisco and his residency in pathology at Brooke
Army Medical Center in San Antonio.
For more information about Precision Pathology Laboratory
Services, visit www.precisionpath.us.
Conference Call: bioAffinity
Technologies Business Update
Date:
Tuesday, Sept. 19, 2023
Time:
4:30 p.m. ET
Toll Free:
1-877-270-2148
International:
1-412-902-6510
Webcast:
Webcast link
A replay of the event will be available
for 90 days at the webcast link above, which can also be found in
the Investor Relations section of bioAffinity’s website at
https://ir.bioaffinitytech.com/.
About CyPath® Lung
CyPath® Lung is a noninvasive, accurate test for early-stage
lung cancer that uses flow cytometry and automated analysis to
reliably predict the presence of lung cancer. Patients who are
prescribed the test collect a sputum sample at home and send the
sample overnight to the laboratory. CyPath® Lung incorporates a
fluorescent porphyrin, TCPP, that is preferentially taken up by
cancer and cancer-related cells. CyPath® Lung’s flow cytometry
platform and AI-developed automated analysis profile the lung
microenvironment to identify cell populations indicative of cancer.
In a recent clinical trial, CyPath® Lung showed 92% sensitivity and
87% specificity in high-risk patients who had small lung nodules
less than 20 millimeters.
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 Laboratory 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
This press release contains certain forward-looking statements
within the meaning of the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These statements are
identified by the use of the words "could," "believe,"
"anticipate," "intend," "estimate," "”expect," "may," "continue,"
"predict," "potential," "project" and similar expressions that are
intended to identify forward-looking statements and include
statements regarding the opportunity to build a commercial
laboratory with scale, accelerating the market uptake and success
of CyPath® Lung, supporting the test’s upcoming pivotal trial,
pursuing the development and commercialization of additional tests,
the Precision Pathology acquisition supporting and enhancing the
Company’s commercial strategy, Precision Pathology being the asset
the Company needs to build scale and efficiency to make CyPath®
Lung a strong success, combining the innovation and expertise of
both companies supporting the launch of the Company’s 1,800-patient
pivotal trial for CyPath® Lung and further advancing its ability to
develop additional products, including a test for COPD, the
opportunity to create a stronger, more complete platform to address
unmet needs in cancer diagnostics and the CyPath® Lung test saving
many lives. These forward-looking statements are based on
management's expectations and assumptions as of the date of this
press release and are subject to a number of 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 pursue the
development and support the commercialization of its CyPath® Lung
test and the risk factors described in the Company's Annual Report
on Form 10-K for the year ended December 31, 2022, the Company's
Quarterly Reports on Form 10-Q, the Company's Current Reports on
Form 8-K and subsequent filings filed with the Securities and
Exchange Commission. The information in this release is provided
only as of the date of this release, and the Company undertakes no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise, after the date on which the statements are made or to
reflect the occurrence of unanticipated events, except as required
by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230919752484/en/
bioAffinity Technologies Julie Anne Overton Director of
Communications jao@bioaffinitytech.com
LHA Investor Relations Tirth T. Patel tpatel@lhai.com
bioAffinity Technologies (NASDAQ:BIAF)
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