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Mediven's MDx Tests Get CE-IVD Mark

NEW YORK (GenomeWeb) – Malaysian diagnostics firm Medical Innovation Ventures (Mediven) said that it received the CE-IVD mark for its molecular diagnostic tests for influenza and cholera. 

Its GenoAmp Real-Time RT-PCR kit for influenza A and B detects influenza A serotypes H1N1 and H3N2, and influenza B from viral RNA in a single tube within four hours, the company said. 

Its GenoAmp Cholera Octaplex is a thermal-stable end-point PCR test that requires no cold chain. It detects Vibrio cholera in human stool and is designed to amplify seven different genes of V. cholera simultaneously. The assay can be performed by a simple addition of boiled DNA sample to the tube, followed by automated capillary electrophoresis, Mediven said. 

It added that the assay can detect all serogroups of O1, O139, and non-O1, non-0139 of V. cholera, as well as biotypes El Tor and Classical, all the toxin genes, and O139-specific gene sequences. 

"Fast and early detection of these diseases can make a positive impact in Southeast Asia and other emerging healthcare markets," Mediven Executive Editor Ariff Ismail said in a statement. "With these new series of products, Mediven is able to cover major infectious diseases that are relevant to the region."