NeoGenomics has secured conditional approval from the New York State Department of Health (NYSDOH) for two of its next-generation sequencing (NGS) tests, the Neo Comprehensive Solid Tumor assay and the NeoTYPE DNA & RNA Lung.
This approval grants immediate commercial access to these diagnostic tests in the state of New York.
The newly approved NGS tests offer enhanced diagnostic value and are more cost-effective compared to single gene testing, claimed the company.
They are instrumental in directing first-line treatment for various solid tumours, including non-small cell lung cancer.
NeoGenomics CCO Warren Stone said: “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.
“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.”
In New York alone, cancer diagnoses reach 116,000 annually, with lung cancer being the predominant cause of cancer-related mortality.
The Neo Comprehensive Solid Tumor assay provides a pan-cancer genomic profiling solution that adheres to National Comprehensive Cancer Network (NCCN) guidelines for diverse cancers.
The NeoTYPE DNA & RNA Lung test employs similar technology but focuses on a narrower NGS panel designed to meet a critical need in lung cancer testing throughout the state.
These assays can detect genetic markers that may be overlooked by cancer-specific profiles or single-gene tests due to their broad gene panel analysis capabilities.
NeoGenomics operates laboratories across the US that are certified by the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP).
On 8 October, NeoGenomics launched AML Express, an NGS assay designed to provide rapid, comprehensive genetic profiling for patients with acute myeloid leukaemia (AML).
