NEW YORK (GenomeWeb) – Claritas Genomics announced today that it has received New York State (NYS) Department of Health approval for its bone marrow failure, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), and nephrotic syndrome region of interest tests, as well as a mitochondrial DNA assay.
HLH is a rare disorder characterized by severe inflammation due to the proliferation of lymphocytes and macrophages, and includes some forms of MAS. Claritas' test evaluates 20 genes associated with the conditions. The nephrotic syndrome test focuses on 42 genes linked to the kidney disorder, while the bone marrow failure assay covers 87 genes.
According to 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 — it now offers six tests with NYS approval, following clearance of its clinical exome and pediatric neurology region of interest tests in January.
All of Claritas' test are based on its dual-capture, dual-sequencing platform method.
"New York State approval for our entire menu is a key component of our quality and regulatory strategy," Claritas Executive Chairman David Margulies said in a statement. "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."