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AusDiagnostics Hemochromatosis MDx Receives CE-IVD Mark

NEW YORK (GenomeWeb) – Australian startup AusDiagnostics announced today that it has received CE-IVD marking for its molecular diagnostic assay that detects hemochromatosis, an inherited genetic disease that causes iron overload and eventual organ failure in patients.

The firm's test, which is available as a kit, measures the concentration of the wild type and mutant alleles of hFE — a protein identified as responsible for deficiencies in iron transport — at three different mutation sites, detecting susceptibility from a small blood sample. Mutant hFE protein impairs normal uptake of iron, causing it to pile up at different sites.  

AusDiagnostics' multiplex tandem PCR technology allows researchers to multiplex several gene targets and detects low concentrations of pathogens in samples of other pathogens in about three hours, according to the firm.

"This is a new area for AusDiagnostics kits and is one of the first of several genetic tests that the company plans for release," AusDiagnostics Managing Director Keith Stanley said in a statement.

The kit is also included in the Australian Register of Therapeutic Goods, the company said.