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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

More Boosters for US

Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes.

From a Pig

A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports.

For Privacy's Sake

Wired reports that more US states are passing genetic privacy laws.

Science Paper on How Poaching Drove Evolution in African Elephants

In Science this week: poaching has led to the rapid evolution of tuskless African elephants.