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Dx Focus: Clinical and Regulatory PCR News

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The US Food and Drug Administration has issued an emergency use authorization for Roche's RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus.

The Roche kit, which detects RNA from the 2009 H1N1 Influenza A virus, is used in conjunction with the RealTime ready RNA Virus Master kit, also provided by Roche. The assay is carried out on the Roche MagNA Pure LC platform for nucleic acid isolation and the LightCycler 2.0 system for real-time PCR.

Under the EUA, Roche can provide the RealTime ready Influenza A/H1N1 Detection Set to CLIA high-complexity labs for the duration of the declaration of emergency.

Separately, Roche announced that it "performs sequence comparisons with all available 2009 H1N1 Influenza Virus sequences on a regular basis." In its most recent evaluation of the assay's detection set primers and probes, conducted in mid-November, "no significant or relevant changes were identified in the published 2009 H1N1 Influenza sequences that could affect the performance of the Roche assay."


Roche also said this week that the FDA has approved its cobas TaqScreen MPX Test to screen source plasma in pools comprised of up to 96 individual donations.

The test is designed to simultaneously and directly detect HIV, hepatitis C virus RNA, and hepatitis B viral DNA. It was approved in the US last year for screening plasma specimens from blood donors and earlier this year received the CE Mark in Europe for screening source plasma.

The cobas TaqScreen MPX Test runs on the real-time PCR cobas s 201 system, which runs multiple channels using multi-dye technology in order to enable simultaneous detection of several viruses.

Roche said that it is developing another multi-dye assay for the same platform, called the cobas TaqScreen DPX test, that will simultaneously provide a quantitative result for B19 virus and a qualitative result for hepatitis A virus.


The FDA has cleared for marketing Prodesse's ProParaflu+ assay, a molecular test that detects and differentiates parainfluenza 1, 2, and 3 viruses.

Prodesse is a wholly owned subsidiary of Gen-Probe.

The ProParaflu+ assay uses real-time RT-PCR to identify the parainfluenza 1, 2, and 3 viruses from nasal swabs. The assay uses the same internal control as Prodesse's other tests for respiratory infectious diseases, "so a single nucleic acid extract can be tested with any combination of these products," the company said.


Nanosphere has received 510(k) clearance from the FDA to update the package insert for its Verigene Respiratory Virus Nucleic Acid Test on Verigene SP System to include reactivity with influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus.

The FDA cleared the RVNATSP assay in October for the differential diagnosis of influenza A, influenza B, and RSV infections. "Although the RVNATSP has been shown to detect the 2009 H1N1 influenza virus in cultured isolates, the performance characteristics of this device with patient specimens that are positive for the 2009 H1N1 influenza virus have not been established," the company said.

The RVNATSP incorporates viral RNA extraction and isolation, RT-PCR amplification, and multiplexed detection in an automated system.


Focus Diagnostics has gained a CE Mark in Europe for its Simplexa Influenza A H1N1 (2009) test. This follows an emergency use authorization that the company received for the test from the FDA in October.

The Simplexa Influenza A H1N1 (2009) test is the result of a global distribution agreement between Focus Diagnostics and 3M, under which Focus will develop and offer Simplexa-branded molecular diagnostic test kits for the 3M Integrated Cycler, a PCR system that can process up to 96 samples per run and provide results in 30 to 85 minutes.

Focus, a unit of Quest Diagnostics, plans to launch additional Simplexa test kits on the 3M Integrated Cycler for infectious diseases in 2010.

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