ALISO VIEJO, Calif., Dec. 16, 2019 /PRNewswire/ -- Ambry Genetics® (Ambry), a leading clinical genetic testing company, announced today that the New York State Clinical Laboratory Evaluation Program (CLEP) has approved Ambry's next-generation, paired RNA and DNA genetic test for hereditary cancer risk. +RNAinsight™ enables clinicians – for the first time ever – to conduct both DNA and RNA genetic testing at the same time. This is the first genetic testing advancement in over a decade to significantly increase the diagnostic yield (meaning the number of patients identified with a specific hereditary risk for cancer) in genes like BRCA1 and BRCA2. With +RNAinsight, Ambry is the first and only lab to offer paired RNA and DNA genetic testing for hereditary cancer risk.
The New York State Department of Health established CLEP to ensure test accuracy and reliability for the state's residents through strict evaluation standards. With CLEP approval, Ambry's +RNAinsight is now available to patients in New York and in all 50 states.
"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," said 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 on whether a genetic variant (an error in our DNA) increases cancer risk. Moreover, standard DNA testing excludes large portions of DNA, and therefore can miss disease causing mutations and inaccurately provide a negative result. Adding +RNAinsight (RNA added to the current DNA test) overcomes these limitations for a significant number of patients and provides more evidence than DNA alone about whether the genes in our DNA have mutations. Clinicians can now use this information from +RNAinsight with patients and their relatives to try to detect cancer early and to prevent cancer from developing.
ABOUT +RNAINSIGHT™ +RNAinsight™, paired with Ambry Genetics' hereditary cancer DNA tests, uses next-generation sequencing to concurrently analyze a patient's DNA and RNA, another layer of genetic information. +RNAinsight identifies more patients who have mutations that increase their cancer risks than through standard DNA-only testing by overcoming limitations of DNA testing. +RNAinsight enables more accurate identification of patients with increased genetic risks for cancer, finds actionable results that may otherwise be missed, and decreases the frequency of inconclusive results. +RNAinsight is now available through doctors and genetic counselors around the country. For more information on +RNAinsight, please go to ambrygen.com/RNAinsight.
ABOUT AMBRY GENETICS ® Ambry Genetics, as part of Konica Minolta Precision Medicine, excels at translating scientific research into clinically actionable test results based upon a deep understanding of the human genome and the biology behind genetic disease. Our unparalleled track record of discoveries over 20 years, and growing database that continues to expand in collaboration with academic, corporate and pharmaceutical partners, means we are first to market with innovative products and comprehensive analysis that enable clinicians to confidently inform patient health decisions. We care about what happens to real people, their families, and the people they love, and remain dedicated to providing them and their clinicians with deeper knowledge and fresh insights, so together they can make informed, potentially life-altering healthcare decisions. For more information, please visit ambrygen.com.
For more information on risk factors for hereditary cancer, please visit cancer.gov's fact sheet on hereditary cancer and genetic testing.