Skip to main content
Premium Trial:

Request an Annual Quote

Claritas Wins NY State Approval for Three Dx Tests

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."

The Scan

Steps for Quick Review

The US Food and Drug Administration is preparing for the quick review of drugs and vaccines for the Omicron variant, according to the Wall Street Journal.

Moving Away From Using Term 'Race'

A new analysis finds that geneticists are using the term "race" in their papers less than in years past, as Science reports.

Point of the Program

The Guardian writes that some scientists have called the design of a UK newborn sequencing program into question.

Science Papers Present Multi-Omic Analysis of Lung Cells, Regulation of Cardiomyocyte Proliferation

In Science this week: a multi-omic analysis of lung cells focuses on RIT1-regulated pathways, and more.