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Thermo Fisher Scientific Obtains CE-IVD Mark for PCR-Based GI Bacteria Panel

NEW YORK – Thermo Fisher Scientific said on Monday that it has received CE-IVD marking for its TaqPath Enteric Bacterial Select Panel, a PCR-based assay developed to detect common gastrointestinal (GI) bacteria.

The panel, which the company said was validated and registered under the In Vitro Diagnostic Device Directive (IVDD) in May of this year, uses PCR to detect a range of common GI bacteria in stool samples, including Salmonella spp., Shigella spp., Campylobacter jejuni, Campylobacter coli, and Campylobacter upsaliensis.

Thermo Fisher said the panel can produce results in about two hours with more than 98 percent sensitivity and specificity. The test can also be scaled up to accommodate up to 93 samples in one single run, and when conducted on Thermo Fisher’s QuantStudio 5 and QuantStudio 5 Dx platforms, results from the test can be interpreted and generated automatically.