NeoGenomics Receives New York State Approval for Neo Comprehensive™ Solid Tumor Test
October 22 2024 - 8:10AM
Business Wire
Approval Broadens Patient Access to Company’s
NGS Test for More Accurate Diagnostic and Prognostic Pan-Tumor
Cancer Results
NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology
testing services company, today announced that the New York State
Department of Health (NYSDOH) has granted the company conditional
approval for its Neo Comprehensive Solid Tumor assay and NeoTYPE®
DNA & RNA Lung, allowing for immediate commercial access in the
state of New York. These next-generation sequencing (NGS) tests
deliver better diagnostic value and cost-effectiveness than single
gene testing and direct the first-line treatment of diverse solid
tumors, including non-small cell lung cancer.
New York State is known for having stringent validation
standards for laboratory-developed tests. Clinical laboratories
testing specimens from New York residents must obtain a clinical
laboratory permit from NYSDOH to help ensure the accuracy and
reliability of clinical tests.
“Receiving approval for Neo Comprehensive Solid Tumor and
NeoTYPE DNA & RNA Lung from NYSDOH marks a significant
milestone for NeoGenomics, confirming the company's high standards
for developing new tests, the quality of our lab results, and the
impact these tests have on guiding management of diverse cancers,”
said Warren Stone, CCO of NeoGenomics. “More importantly,
NeoGenomics can now bring these tests to more healthcare providers
and their patients across New York state, continuing our mission of
transforming care for cancer patients.”
Each year, 116,000 people are diagnosed with cancer in New York
State, with lung cancer representing the leading cause of
cancer-related death. Neo Comprehensive offers physicians a
pan-cancer genomic profiling solution that aligns with National
Comprehensive Cancer Network (NCCN) guidelines for diverse cancers.
NeoTYPE DNA & RNA Lung leverages the same technology as Neo
Comprehensive Solid Tumor but in the context of a more focused NGS
panel that addresses an unmet need in lung cancer testing across
the state. These tests analyze a broad panel of genes, which detect
less common genetic markers that cancer-specific profiles or
single-gene tests may miss.
NeoGenomics operates Clinical Laboratory Improvement Amendments
(CLIA) certified and College of American Pathologists (CAP)
accredited laboratories for full-sample processing across the U.S.
Widely recognized as the highest standard for clinical laboratory
accreditations, the CAP Laboratory Accreditation Program is
designed to ensure laboratories meet stringent requirements and
standards of quality, safety, and accuracy.
About NeoGenomics, Inc.
NeoGenomics, Inc. specializes in cancer genetics testing and
information services, providing one of the most comprehensive
oncology-focused testing menus for physicians to help them diagnose
and treat cancer. The Company's Advanced Diagnostic Division also
serves pharmaceutical clients in clinical trials and drug
development.
Headquartered in Fort Myers, FL, NeoGenomics operates
CAP-accredited and CLIA-certified laboratories for full-service
sample processing in Fort Myers, Florida; Aliso Viejo and San
Diego, California; Research Triangle Park, North Carolina; and
Houston, Texas; and a CAP-accredited full-service,
sample-processing laboratory in Cambridge, United Kingdom.
NeoGenomics also has several, small, non-processing laboratory
locations across the United States for providing analysis services.
NeoGenomics serves the needs of pathologists, oncologists, academic
centers, hospital systems, pharmaceutical firms, integrated service
delivery networks, and managed care organizations throughout the
United States, and pharmaceutical firms in Europe and Asia.
Forward-Looking Statements
This press release includes forward-looking statements. These
forward-looking statements generally can be identified by the use
of words such as “anticipate,” “expect,” “plan,” “could,” “would,”
“may,” “will,” “believe,” “estimate,” “forecast,” “goal,”
“project,” “guidance,” “plan,” “potential” and other words of
similar meaning, although not all forward-looking statements
include these words. This press release includes forward-looking
statements. These forward-looking statements address various
matters, including statements regarding improving operational
efficiency, returning to profitable growth and its ongoing
executive recruitment process. Each forward-looking statement
contained in this press release is subject to a number of risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statement. Applicable risks
and uncertainties include, among others, the Company's ability to
identify and implement appropriate financial and operational
initiatives to improve performance, to identify and recruit
executive candidates, to continue gaining new customers, offer new
types of tests, integrate its acquisitions and otherwise implement
its business plan, and the risks identified under the heading "Risk
Factors" contained in the Company's Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q and the Company's other filings with
the Securities and Exchange Commission.
We caution investors not to place undue reliance on the
forward-looking statements contained in this press release. You are
encouraged to read our filings with the SEC, available at
www.sec.gov, for a discussion of these and other risks and
uncertainties. The forward-looking statements in this press release
speak only as of the date of this document (unless another date is
indicated), and we undertake no obligation to update or revise any
of these statements. Our business is subject to substantial risks
and uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
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version on businesswire.com: https://www.businesswire.com/news/home/20241022061479/en/
Investor Contact Kendra Sweeney
kendra.sweeney@neogenomics.com
Media Contact Andrea Sampson
asampson@sampsonprgroup.com
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