NEW YORK – NeoGenomics said Tuesday that the New York State Department of Health has granted conditional approval for its solid tumor genomic profiling assay, Neo Comprehensive, as well as its more focused lung cancer test, NeoType DNA & RNA Lung.
The new status allows immediate commercial access to the next-generation sequencing (NGS) tests by doctors in the state, which has more stringent validation standards for laboratory-developed tests than the majority of the country.
NeoGenomics said its aim in providing the two newly approved tests is to improve diagnostic value and cost-effectiveness compared to single-gene testing for oncologists seeking to tailor treatment to their patients' molecular features.
The company's comprehensive assay covers 517 genes with potential impact across multiple tumor types, as well as calculations of microsatellite instability and tumor mutational burden.
NeoType DNA & RNA Lung is a narrower NGS panel focused on actionable alterations specific to lung cancer. These include 44 genes analyzed by DNA and 19 by RNA.