New York State OKs NeoGenomics' pancancer solid tumor, targeted lung NGS tests

The New York State Department of Health has granted conditional approval for NeoGenomics' next-generation sequencing (NGS) tests, the Neo Comprehensive Solid Tumor assay, and NeoType DNA and RNA Lung.

"NeoTYPE DNA and 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," NeoGenomic said as part of its announcement. "These tests analyze a broad panel of genes, which detect less common genetic markers that cancer-specific profiles or single-gene tests may miss."

Conditional approval allows for immediate commercial access in the state of New York, NeoGenomics also said, adding that lung cancer represents the leading cause of cancer-related death in the state.

NeoType DNA and RNA Lung runs as a 50-gene panel (44 genes analyzed by DNA and 19 by RNA) designed to detect single nucleotide variants (SNV), insertions/deletions (InDels), copy number variants (CNV), and RNA fusions, and splice variants, plus microsatellite instability (MSI) and tumor mutation burden (TMB) analysis, according to the NeoGenomics.

The pancancer Neo Comprehensive Solid Tumor assay can sequence 517 genes by DNA for SNVs and InDels, 59 genes by DNA for CNVs, and 55 genes by RNA for known and novel fusions and splice variants, according to the company. The assay also provides TMB and MSI analysis.

In its announcement, NeoGenomics noted that the tests align with National Comprehensive Cancer Network guidelines for diverse cancers.

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