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.
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