NeoGenomics Receives New York State Approval for Neo Comprehensive™ Solid Tumor Test

Rhea-AI Summary

NeoGenomics (NASDAQ: NEO) has received conditional approval from the New York State Department of Health for its Neo Comprehensive Solid Tumor assay and NeoTYPE® DNA & RNA Lung test. This approval allows for immediate commercial access in New York, known for its stringent validation standards for laboratory-developed tests.

These next-generation sequencing (NGS) tests offer improved diagnostic value and cost-effectiveness compared to single gene testing, guiding first-line treatment for various solid tumors, including non-small cell lung cancer. The approval enables NeoGenomics to expand its services to more healthcare providers and patients in New York, where approximately 116,000 people are diagnosed with cancer annually.

The tests align with National Comprehensive Cancer Network (NCCN) guidelines and can detect less common genetic markers that cancer-specific profiles or single-gene tests might miss. NeoGenomics operates CLIA-certified and CAP-accredited laboratories across the U.S., ensuring high-quality standards for clinical testing.

Positive

• Received conditional approval from New York State Department of Health for Neo Comprehensive Solid Tumor assay and NeoTYPE® DNA & RNA Lung test
• Immediate commercial access granted in New York State
• Tests offer improved diagnostic value and cost-effectiveness compared to single gene testing
• Aligns with National Comprehensive Cancer Network (NCCN) guidelines for diverse cancers
• Expands service availability to more healthcare providers and patients in New York

Negative

• None.

Insights

Medical Research Analyst

The approval of Neo Comprehensive Solid Tumor and NeoTYPE DNA & RNA Lung tests by the New York State Department of Health is a significant development for NeoGenomics. This broadens access to advanced cancer diagnostics in a state with 116,000 new cancer diagnoses annually. The tests offer comprehensive genomic profiling, aligning with NCCN guidelines and potentially improving diagnostic accuracy and treatment decisions.

These NGS-based tests provide several advantages over single-gene testing:

• More cost-effective
• Ability to detect rare genetic markers
• Pan-cancer applicability
• Alignment with current treatment guidelines

The stringent NYSDOH approval process validates NeoGenomics' test quality and development standards. This could lead to increased adoption by healthcare providers in New York, potentially boosting test volumes and revenue for NeoGenomics in the medium term.

Market Research Analyst

This regulatory approval represents a strategic market expansion for NeoGenomics in the lucrative New York market. The company's ability to meet NYSDOH's stringent standards enhances its credibility and may lead to increased market share in oncology testing. Key market implications include:

• Expanded addressable market in a populous state
• Potential for increased test volumes and revenue
• Enhanced competitive position against other diagnostic companies
• Possible catalyst for adoption in other states with strict regulatory environments

The approval of both a comprehensive pan-cancer test and a lung-specific test allows NeoGenomics to cater to different physician preferences and testing strategies. This flexibility could drive adoption across various oncology practices and potentially lead to long-term revenue growth and market penetration in the oncology diagnostics sector.

Approval Broadens Patient Access to Company’s NGS Test for More Accurate Diagnostic and Prognostic Pan-Tumor Cancer Results

FT. MYERS, Fla.--(BUSINESS WIRE)-- 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.

View source 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

Source: NeoGenomics, Inc.

FAQ

What tests did NeoGenomics (NEO) receive approval for in New York State?

NeoGenomics received conditional approval from the New York State Department of Health for its Neo Comprehensive Solid Tumor assay and NeoTYPE® DNA & RNA Lung test.

How do NeoGenomics' (NEO) newly approved tests compare to single gene testing?

NeoGenomics' NGS tests offer improved diagnostic value and cost-effectiveness compared to single gene testing, and can detect less common genetic markers that cancer-specific profiles or single-gene tests might miss.

What is the significance of NeoGenomics (NEO) receiving approval in New York State?

New York State is known for having stringent validation standards for laboratory-developed tests. The approval allows NeoGenomics to expand its services to more healthcare providers and patients in a state where approximately 116,000 people are diagnosed with cancer annually.

What accreditations do NeoGenomics' (NEO) laboratories have?

NeoGenomics operates Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited laboratories across the U.S., which are widely recognized as the highest standard for clinical laboratory accreditations.