NEW YORK – Ambry Genetics announced on Monday 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.
A study published in JAMA Network Open later that month found that the addition of RNA-based genetic testing through +RNAinsight clarified 88 percent of the inconclusive variants the researchers found in genes linked to hereditary breast and ovarian cancer, Lynch syndrome, and hereditary diffuse gastric cancer cases and led to changes in clinical management for 44 percent of patients.
With CLEP approval, +RNAinsight is now available to patients in New York and in all 50 states, Ambry said.
"With +RNAinsight, New Yorkers can now receive the most accurate and comprehensive determination of whether they have genetic mutations that increase their risks for breast, colon, and other hereditary cancers," Ambry CEO Aaron Elliott said in a statement. "New York conducts the most rigorous state reviews of lab-developed tests, and its approval further validates +RNAinsight as a new clinical standard for hereditary cancer testing."