Claritas Genomics Receives Full New York State (NYS) Approval for its Clinical Exome and Pediatric Neurology Region of Interest Diagnostic Tests
Claritas Genomics' clinical laboratories among few in the world to receive CLIA Licensure, Clinical ISO 15189 Certification, and New York State Clinical Laboratory Licensure
BOSTON, Jan. 4, 2017 /PRNewswire-USNewswire/ -- Today Claritas Genomics announced it has received full approval from the New York State Department of Health for its Clinical Exome and Pediatric Neurology Region of Interest diagnostic tests. Claritas offers genetic testing services for children in all 50 states and globally.
"New York State is known for having a rigorous evaluation process," says Mary Ellen Cortizas, Claritas Genomics Chief Operating Officer. "Today's approval is a key component of our quality and regulatory strategy. Claritas's combination of NYS, ISO 15189, and CLIA Certification demonstrates our commitment to Total Quality Management Practice to ensure the best possible results for patients and families."
The Claritas Clinical Exome is a first line test for patients with complex, multi-systemic symptoms. It can also be the next step for a patient when no other testing has uncovered a molecular explanation for the patient's medical issues. This test is ideal for patients who have conditions with genetic and phenotypic heterogeneity, i.e.; different mutations in the same gene that can sometimes give rise to strikingly different symptoms where a single gene test may not fully explore all causes.
The Pediatric Neurology Region of Interest test is designed to give providers the power of an exome with the focus of a panel, with eight neurology focused regions of interest, including Neuromuscular Disorders, Movement Disorders, Epilepsy/Seizures, Brain Malformations, Developmental Delay/Intellectual Disability, Hereditary peripheral neuropathy, Leukodystrophy/Encephalopathy, and Autism.
Both tests use Claritas' innovative dual-capture, dual sequencing platform method that is unique to the industry. This "Orthogonal Approach" simultaneously confirms ~95% of all exome variants with Sanger confirmation for remaining 5%, providing the highest confidence in clinical results.
About Claritas Genomics
Claritas Genomics was created by leading pediatric medical centers Boston Childrens Hospital and Cincinnati Childrens Hospital in partnership with Cerner Corp, WuxiNextCode Genomics, and ThermoFisher Scientific to serve children affected with complex genetic disorders by providing timely and accurate results, resolving families' long search for answers. By combining clinical expertise of the worlds best pediatric specialist with innovative best in class information and genomic platform solutions, Claritas' mission is to improve patient care and enable new discoveries for pediatric precision medicine.
Now is the time to integrate genomic into clinical practice to inform guide and improve medical treatment for kids around the world.
Betsy Stevenson
Director of Corporate Communications
[email protected]
Tel: +1 (860) 984-1424
SOURCE Claritas Genomics
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