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Mediven Receives CE Mark for Molecular, Rapid Immunoassay Tests

NEW YORK (GenomeWeb) – Medical Innovation Ventures (Mediven) has received the CE-IVD mark for molecular and rapid tests that facilitate diagnosis for fecal occult blood, pregnancy, dengue, and tuberculosis.

One of the rapid tests, the ProDetect FOB Rapid Test, is a direct binding immunoassay for rapidly and qualitatively detecting the presence of human occult blood in feces. The other rapid pregnancy tests detect the presence of hCG in urine during the early stages of pregnancy.

Two molecular tests also received the CE mark — the GenoAmpReal-Time RT-PCR test and GenoAmpEndpoint MTB/NTM test. The RT-PCR test is a molecular diagnostic device that detects and differentiates dengue serotypes 1, 2, 3, and 4 from clinical samples. The GenoAmpEndpoint MTB/NTM is a thermostabilized PCR test for the detection of Mycobacterium tuberculosis and non-tuberculosis (atypical) mycobacteria. 

Malaysia-based Mediven said it is focused on the infectious disease diagnostic markets in developing countries.

"The new addition of CE-IVD marked molecular and rapid tests to our product portfolio underlines our focus on addressing the healthcare issues of the bottom billion," said Ariff Ismail, executive director of Mediven, in a statement.