Ambry Genetics

New York State Clinical Laboratory Program Approves +RNAinsight™ To Enhance Genetic Testing for Hereditary Cancers Interview with:

Dr. Aaron Elliott, PhD CEO Ambry Genetics

Dr. Aaron Elliott

Dr. Aaron Elliott, PhD
Ambry Genetics

Dr. Elliott discusses The New York State Clinical Laboratory Evaluation Program (CLEP) approval of +RNAinsight™, a new genetic test for hereditary cancer risk. What is the background for this announcement? What types of cancers can be genetically tested for predisposition? To whom should the testing be offered? 

Response: The New York State Clinical Laboratory Evaluation Program (CLEP) has approved +RNAinsight, which 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 this paired RNA and DNA genetic testing.

Genetics may contribute to individuals’ risk of developing a number of cancers, including breast, ovarian, prostate, colorectal, and others. Approximately five to 10 percent of cancer cases are hereditary, according to the National Cancer Institute. The National Society of Genetic Counselors (NSGC) guidelines indicate who should receive genetic testing to learn whether they have increased risks to develop hereditary cancer. For example, someone with close family members who developed cancer at young ages may be a good candidate. What are the main findings of the underling studies?

Response: 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. What should readers take away from your report?

Response: 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. 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. What recommendations do you have for future research as a result of this work?

Response: 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 inaccurately provide a negative result by missing mutations that may increase cancer risk. 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.


Ambry Genetics Receives New York State Approval to Offer Paired RNA and DNA Genetic Testing for Hereditary Cancer Risk

+RNAinsight™ is now available for New York patients, and will help identify thousands more patients at increased risk for cance


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Last Modified: Dec 18, 2019 @ 6:53 pm

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