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FDA Clears Osmetech’s Cystic Fibrosis Test

NEW YORK (GenomeWeb News) – Osmetech said today that it has received clearance from the US Food and Drug Administration for a genotyping test for cystic fibrosis using the company’s eSensor XT-8 System.

The eSensor Cystic Fibrosis Genotyping Test screens for cystic fibrosis gene carriers in adults of reproductive age, and functions as an aid in newborn screening and as a confirmatory diagnostic test for the disease in newborns and children.

The FDA cleared Osmetech's warfarin sensitivity test for use on the XT-8 system a year ago.

The company said it plans to expand the test menu for its eSensor XT-8 to include an extended warfarin sensitivity test panel, a CYP 2C9 genotyping panel, a venous thrombosis panel, and a respiratory virus pathogen panel.

Company CEO James White said in a statement that the company plans to commercialize its new tests globally, and that it will begin transitioning customers using its eSensor 4800 to the XT-8 system.

The Scan

International Team Proposes Checklist for Returning Genomic Research Results

Researchers in the European Journal of Human Genetics present a checklist to guide the return of genomic research results to study participants.

Study Presents New Insights Into How Cancer Cells Overcome Telomere Shortening

Researchers report in Nucleic Acids Research that ATRX-deficient cancer cells have increased activity of the alternative lengthening of telomeres pathway.

Researchers Link Telomere Length With Alzheimer's Disease

Within UK Biobank participants, longer leukocyte telomere length is associated with a reduced risk of dementia, according to a new study in PLOS One.

Nucleotide Base Detected on Near-Earth Asteroid

Among other intriguing compounds, researchers find the nucleotide uracil, a component of RNA sequences, in samples collected from the near-Earth asteroid Ryugu, as they report in Nature Communications.