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Autogenomics Receives ISO Certification


By Justin Petrone

AutoGenomics said last week that it has received ISO 13485 certification — an International Organization for Standardization standard that covers the requirements for the design and manufacture of medical devices.

TÜV SÜD America, a global inspection firm, was the certification body.

CEO Fareed Kureshy called the certification a "significant milestone" for Autogenomics, which sells a microarray-based molecular diagnostics platform called Infiniti, and has had a number of tests cleared for clinical use in the US and Europe.

In recent years, the Carlsbad, Calif.-based company has had several tests cleared by the US Food and Drug Administration as in vitro diagnostics, including factor II, factor V Leiden, factor II-V Leiden assays for the diagnosis of suspected thrombophilia, as well as an assay for the detection of sensitivity to the anticoagulant drug warfarin..

The company also has 13 CE Marked panels for sale in 15 different countries. According to Kureshy, the recent ISO certification will aid Autogenomics as it "expands its increasing role in the international market."

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