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Rady Children’s Institute for Genomic Medicine Gets NY State Approval for Sequencing Tests

NEW YORK - Rady Children’s Institute for Genomic Medicine said on Thursday that it is has been licensed by New York State to perform clinical molecular testing, including whole-exome and whole-genome sequencing. With the new licensure, the institute can now perform its tests on samples from all US states.

RCIGM's rapid WGS method is intended to enable molecular diagnoses and inform precision care for infants and children with rare genetic conditions within what is often a narrow therapeutic window. The institute's Clinical Genome Center said it delivers a preliminary diagnosis in less than three days for medically urgent cases.

Rady began sequencing children’s genomes for clinical studies in July 2016 and received accreditation by the College of American Pathologists and CLIA certification in 2017. Overall, the institute said that more than one-third of patients it has tested have received a genomic diagnosis, and about 75 percent of those have had a change in medical management based on that discovery.

"New York licensing is an important step in our mission to expand access to genome-informed diagnosis and treatment for children suffering from diseases of unknown origin," Stephen Kingsmore, President and CEO of RCIGM, said in a statement. "Our goal is to make genomic sequencing the standard of care and improve the lives of children and families faced with rare disease."