NEW YORK (GenomeWeb) – Claritas Genomics announced today that it has received New York State Department of Health approval to start offering its Clinical Exome and Pediatric Neurology Region of Interest diagnostic tests in New York.
The company — which was created by Boston Children's Hospital and Cincinnati Children's Hospital in partnership with Cerner, Wuxi NextCode Genomics, and Thermo Fisher Scientific — offers the Clinical Exome test for people with complex, multi-systemic symptoms, or conditions with genetic and phenotypic heterogeneity.
The Pediatric Neurology Region of Interest focuses on eight neurological regions, including neuromuscular disorders, movement disorders, epilepsy and seizures, brain malformations, developmental delay and intellectual disability, hereditary peripheral neuropathy, leukodystrophy and encephalopathy, and autism.
Both tests use Claritas' dual-capture, dual-sequencing platform method.
"New York State is known for having a rigorous evaluation process," Claritas Chief Operating Officer Mary Ellen Cortizas said in a statement. "Today's approval is a key component of our quality and regulatory strategy."
The company's clinical laboratories are also CLIA and ISO 15189 certified, Claritas noted.