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Dx Focus Mar 23, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


This article has been updated from a previous version.

Meridian Bioscience said this week that it has submitted its first molecular amplification-based test, the Illumigene C. difficile molecular diagnostic, for 510(k) approval by the US Food and Drug Administration.

Illumigene is based upon loop amplification, or LAMP, technology. According to Meridian, the technique is isothermal and therefore requires no capital equipment purchase, making molecular diagnostic testing possible for any size laboratory.

The Illumigene C. difficile test detects and amplifies a pathogenic DNA region common to all toxin-producing strains of C. difficile. The test is performed on a small sample of a patient's stool, and can be completed in less than an hour, Meridian said.

Nanosphere's Verigene SP respiratory virus panel has been categorized as "moderate complexity" by the US Food and Drug Administration under the Clinical Laboratory Improvement Amendments act, the company said last week.

The moderate complexity designation allows the test to be run in more settings by a broader group of operators, Nanosphere said. The Verigene RVP is Nanosphere's first test to receive the designation.

The Verigene system is a benchtop molecular diagnostics workstation that uses gold nanoparticle technology to detect nucleic acid and protein targets of interest for a variety of applications. The Verigene SP system adds automated sample preparation to the original system.

Nanosphere's previously cleared FDA products have been categorized as "high complexity," and run on the original Verigene system. The company said that it plans to file all of these and future tests on the Verigene SP, with the goal of receiving moderate complexity designation.

Singapore's Veredus Laboratories has received a CE-IVD mark for its PCR and microarray-based VereFlu test and accompanying VereID Biosystem platform, PCR Insider sister newsletter BioArray News reported this week.

The CE Mark designation allows the firm to market the test for clinical use in Europe.

Veredus first launched VereFlu for research and surveillance purposes in 2008. The test allows researchers to detect, differentiate, and identify influenza A H1, H3, H5, H7, and H9 with subtypes of H1N1, H3N2, H5N1, and H9N2; as well as influenza B, the company said.

The VereFlu test runs on Veredus' VereChip, a 1- by 3-inch silicon chip that combines PCR-based amplification with microarrays. A standard chip can hold as many as 500 individual probes, the company said.

The VereID Biosystem platform comprises a temperature control system, optical reader, biosystem software and bar code reader, and is used in combination with the company's VereChip.

IntelligentMDx said this week that its IMDx 2009 influenza H1N1 real-time RT-PCR assay has been granted Emergency Use Authorization by the US Food and Drug Administration.

IMDx, based in Cambridge, Mass., said the test is the first to be authorized for use on multiple instrument platforms by CLIA high-complexity laboratories to detect and differentiate 2009 influenza A H1N1. The test is authorized for use on Life Technologies' Applied Biosystems 7500; 7500 FAST real-time PCR systems; and 7500 Fast Dx real-time PCR instrument, and produces results in ninety minutes, IMDx said.

As with other EMA-authorized molecular tests for influenza, IMDx's test has not been approved for general use by the FDA and the assay is authorized only for the duration of the emergency period, which will expire on April 26 unless revoked sooner.