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Scienion, Genomica Get CE Mark for Jointly Developed STI Panel

NEW YORK (GenomeWeb) — Scienion and Genomica today announced the CE IVD marking and launch of their jointly developed multiplex molecular assay for sexually transmitted infections.

The launch is a result of a collaboration initiated between the companies in 2012 to integrate Scienion's non-contact array printing, SciFlexarrayer, and associated consumables with Genomica's multiplex PCR and microarray technologies, called Clinical Array Technology (CLART).

The new product, CLART STIs A&B, is a combination of two different detection panels that enables the simultaneous detection of 18 STI-causing microorganisms, including bacteria, viruses, fungi, and parasites.

The companies said they have validated the product in cooperation with reference laboratories, university hospitals, and family planning clinics, obtaining sensitivity and specificity values of 94 percent and 99 percent, respectively, with the exception of Mycoplasma genitalium, which showed reduced sensitivity and specificity in swab samples.

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