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FDA Clears Nanosphere Assay for Coagulation-Linked Gene Mutations

NEW YORK (GenomeWeb News) — Nanosphere today said that the US Food and Drug Administration has cleared a test that detects gene mutations linked with blood coagulation and metabolism disorders.
 
Nanosphere’s F5/F2/MTHFR Nucleic Acid Test runs on the company’s Verigene System and can be applied in single or multiplex formats.
 
It tests for mutations in three specific genes that together can increase the risk of blood clots and resulting ischemic stroke.
 
As GenomeWeb Daily News reported, the FDA last month cleared Nanosphere’s test for gene variants linked to sensitivity to the anticoagulant warfarin.

The Scan

Y Chromosome Study Reveals Details on Timing of Human Settlement in Americas

A Y chromosome-based analysis suggests South America may have first been settled more than 18,000 years ago, according to a new PLOS One study.

New Insights Into TP53-Driven Cancer

Researchers examine in Nature how TP53 mutations arise and spark tumor development.

Mapping Single-Cell Genomic, Transcriptomic Landscapes of Colorectal Cancer

In Genome Medicine, researchers present a map of single-cell genomic and transcriptomic landscapes of primary and metastatic colorectal cancer.

Expanded Genetic Testing Uncovers Hereditary Cancer Risk in Significant Subset of Cancer Patients

In Genome Medicine, researchers found pathogenic or likely pathogenic hereditary cancer risk variants in close to 17 percent of the 17,523 patients profiled with expanded germline genetic testing.