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Medical Devices / Submissions and Approvals

Australian Startup Receives CE-IVD Mark for Hemachromatosis Assay

Dec. 12, 2018

AusDiagnostics has gained the CE Mark for a molecular diagnostic assay that can detect hemochromatosis, an inherited disorder that causes the body to absorb an excessive amount of iron that can lead to organ failure.

The test kit uses a blood sample to identify a protein responsible for deficiencies in iron transport at three different mutation sites and to assess the patient’s susceptibility.

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

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