Claritas Genomics Receives New York State (NYS) Approval for Bone Marrow Failure, HLH/MAS, Nephrotic Syndrome, and Mitochondrial DNA Tests


BOSTON, June 14, 2017 — Today Claritas Genomics announced it has received conditional approval from the New York State Department of Health for 3 additional Region of Interest assays and a Mitochondrial DNA assay, bringing the number of Claritas NYS approved tests to six.

Claritas’ inherited Bone Marrow Failure, HLH/MAS, and Nephrotic Syndrome Regions of Interest as well as the Claritas Clinical Exome companion Mitochondrial DNA analysis are now available to New York State patients, in addition to NYS approved  Claritas Clinical Exome,  a first-line test for patients with complex, multi-systemic symptoms, and the Pediatric Neurology Regions of Interest test.  All tests were designed in partnership with subject matter experts from Boston Children’s Hospital, and include relevant genes and known pathogenic deep intronic variants.

New York State approval for our entire menu is a key component of our quality and regulatory strategy,” says David Margulies, MD and Claritas Executive Chair. “Today’s approval, Claritas’ 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.”

All the tests employ Claritas’ innovative dual-capture, dual sequencing whole exome platform method that is unique to the industry. This “Orthogonal Approach”, provides the highest confidence in clinical results, while the whole exome platform allows to add additional testing without additional sequencing costs.

Clinical interpretation is facilitated by WuxiNextCODE’s Clinical Sequence Analyzer (CSA) software. The WuXi NextCODE CSA is the world’s most widely-used system for sequence-based rare disease diagnosis. It provides access through every interface to an always-on, fully-harmonized knowledgebase of all major global databases and reference sets; the ability to conduct queries according to a range of modes of inheritance without specialized informatics expertise; and instant visualization of mutations in raw sequence data.

More information regarding the Claritas’ test menu can be found at www.claritasgenomics.com.
For ordering information, email info@claritasgenomics.com, visit our website at claritasgenomics.com or call Client Services at (617)553-5880/(855)373-9003(toll free).

About Claritas Genomics

Claritas Genomics was created by leading pediatric medical centers Boston Children’s Hospital and Cincinnati Children’s 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 world’s best pediatric specialists 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 genomics into clinical practice to inform, guide and improve medical treatment for kids around the world.

Contacts
Claritas Genomics
Mary Ellen Cortizas
Chief Operating Officer
maryellen.cortizas@claritasgenomics.com 
+1 781 454 8675 

WuXi NextCODE
Edward Farmer
EVP Communications & New Ventures
efarmer@wuxinextcode.com
 +1 781 775 6206

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SOURCE Claritas Genomics

Related Links

http://www.claritasgenomics.com