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Dx Focus May 19, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


EraGen Biosciences said today that the US Food and Drug Administration has granted 510(k) market clearance for EraGen's MultiCode-RTx HSV 1&2 kit.

The MultiCode-RTx HSV 1&2 kit is a PCR-based qualitative in vitro diagnostic test for detecting and typing herpes simplex virus 1 and 2 DNA in vaginal lesions from symptomatic female patients to aid in diagnosis of genital herpes.

The kit is based on the company's synthetic DNA base pairs, isoC and isoG, which are probe-free, specific to each other, and do not pair with the natural bases. This allows for the creation of DNA strands that result in superior specificity than traditional molecular assays, according to the company.

In a statement, Maria Foster, EraGen's vice president of commercial operations, said that clinical laboratories can use the newly approved kit to detect HSV types 1 or 2 in approximately four hours using a common nucleic acid extraction system and real-time PCR instrument.

Molecular Detection this week announced the commercial launch of the Detect-Ready MRSA assay.

In addition, Molecular Detection, based in Wayne, Pa., said that it has inked an exclusive deal with Kent, UK-based Launch Diagnostics to distribute the assay in the UK, France, and Ireland.

The Detect-Ready MRSA assay is a qualitative real-time PCR in vitro diagnostic test for directly detecting methicillin-resistant Staphylococcus aureus nasal colonization, to aid in the prevention and control of MRSA infections in hospitals and other healthcare settings.

The test's proprietary technology provides a "differential diagnosis engine" that minimizes false positives and negatives often experienced with other diagnostic screening kits, Molecular Detection and Launch Diagnostics said.

Testing samples are collected with nasal swabs and added to the assay's pre-mixed reagents, providing a result in less than three hours, the companies said. The kits do not require refrigeration, and are compatible with multiple RT-PCR platforms such as the Roche LightCycler, Qiagen RotorGene, and Cepheid SmartCycler.

The kit has also received the CE Mark for sales in the European Union.