Ambry Genetics Gains NYS Approval for Paired RNA, DNA Genetic Test

Ambry Genetics announced that its +RNAinsight combined DNA-RNA genetic test for hereditary cancer syndromes has received approval from the New York State Clinical Laboratory Evaluation Program (CLEP).

The +RNAinsight test, which was launched in October, enables clinicians to conduct both DNA and RNA genetic testing at the same time, with the aim of returning more specific results to patients by using RNA sequencing to definitively classify otherwise ambiguous genetic alterations.

The test adds RNA sequencing of a group of target genes — including BRCA1, BRCA2, TP53, PTEN, and PALB2 — to the company’s existing DNA sequencing panel. For patients whose physicians order +RNAinsight alongside the company’s 34-gene CancerNext DNA panel — or with smaller custom panels if requested — Ambry will perform parallel RNA testing of 18 genes, chosen based on their propensity to harbor the types of splice variants that RNA can either uncover or help better classify, Ambry Senior VP of R&D Brigette Davis told GenomeWeb in October.

Source: https://www.genomeweb.com/regulatory-news-fda-approvals/ambry-genetics-gains-nys-approval-paired-rna-dna-genetic-test