The New York State clinical laboratory evaluation program (CLEP) has approved +RNAInsight, a next-generation paired DNA and RNA genetic test for hereditary cancer risk from Ambry Genetics, Aliso Viejo, Calif.
The +RNAInsight test enables clinicians to perform DNA and RNA genetic testing at the same time. The test significantly increases the diagnostic yield—meaning the number of patients identified with a specific hereditary risk for cancer—when testing for mutations in cancer-associated genes such as BRCA1 and BRCA2.
CLEP was established to ensure test accuracy and reliability for the state’s residents through strict evaluation standards. With CLEP approval, +RNAInsight is now available to patients in all 50 states, including New York.
Aaron Elliott, PhD, Ambry Genetics.
“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,” says Aaron Elliott, PhD, CEO of Ambry Genetics. “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.”
DNA testing alone—the previous clinical standard to determine hereditary cancer risk—may provide an inconclusive result about whether a genetic variant increases cancer risk. Moreover, standard DNA testing excludes large portions of DNA, and can therefore miss disease-causing mutations and inaccurately provide a negative result.
Using the +RNAInsight test to add RNA to current DNA testing overcomes such limitations for a significant number of patients, and provides more evidence about whether a patient’s DNA includes mutations that increase the risk of cancer. Clinicians can use +RNAInsight test results with patients and their relatives to detect cancer early and prevent cancer from developing.
For more information, visit Ambry Genetics.
