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Dx Focus: FDA Clears Quidel Flu, RSV, hMPV Assays; Unilabs to Market Diagnoplex's Colox Test


The US Food and Drug Administration has granted 510(k) clearance to Quidel's Molecular Influenza A+B and RSV+hMPV assays for use on Life Technologies' QuantStudio Dx real-time PCR instrument, the companies said this week.

The Quidel Molecular Influenza A+B assay detects influenza A and/or B virus, but does not differentiate influenza A subtypes. However, the assay is able to detect subtype H7N9, which has caused more than one hundred infections to date in China, with a mortality rate of approximately 30 percent.

FDA also cleared the assay for the detection of H3N2v, a variant influenza virus that has caused infection in patients exposed to infected swine at agricultural fairs in the United States.

Meantime, the Quidel Molecular RSV+hMPV assay detects the presence of respiratory syncytial virus and/or human metapneumovirus. RSV is a respiratory virus that infects the lungs and breathing passages, and although most infections are generally mild, some can be severe, especially among young children, the immunocompromised, and the elderly.

hMPV was identified in 2001 and accounts for approximately 7.1 percent of respiratory tract infections. The virus appears to be distributed worldwide, and virtually all children have been exposed to hMPV by the age of five. Like RSV, hMPV generally causes mild respiratory tract infection, but can severely affect young children, the immunocompromised, and the elderly.

QuantStudio Dx is Life Tech's flagship diagnostics instrument. The instrument features a touch screen, reagent and sample tracking, and a laboratory information management systems interface specifically designed for ease of use in diagnostic laboratories. The instrument also features an optional test development mode for research use only and custom test development.

Both Quidel and Life Tech will sell and distribute the Quidel Molecular Influenza A+B and RSV+hMPV assays and QuantStudio Dx in the US and Europe. Both the assays and instrument are CE-IVD marked for diagnostic use in Europe.

The companies have an agreement in place to develop and commercialize real-time PCR assays for the QuantStudio Dx. Also, under a previously signed agreement, Life Tech is marketing Quidel's PCR-based assays for use on the ABI 7500 Fast Dx Real-Time PCR system in Europe.

The FDA cleared Quidel's Molecular Direct C. difficile assay for both instrument platforms in March. Meantime, Quidel's Molecular Influenza A+B and RSV+hMPV assays were previously 510(k)-cleared by the FDA for use with the ABI 7500 Fast Dx and Cepheid's SmartCycler II.

Diagnoplex and Unilabs said this week that they have signed an agreement to commercialize Colox, Diagnoplex's minimally invasive colorectal cancer assay, within the Unilabs network.

The test will be available initially in the Swiss and Swedish markets, the companies said.

Colox, Diagnoplex's lead product, is a PCR-based test intended for the systematic screening of colorectal cancer. The gene signature underlying Colox has been designed to detect early and advanced disease stages with outstanding results and reliability.

Colox uses information from nucleic acids carried by peripheral blood mononuclear cells, which are instrumental in tumor-host interactions and are involved in the earliest stages of tumor formation. The test's ability to screen for the host response enables the detection of colorectal cancer risk at the earliest and even pre-cancerous stages, Diagnoplex said.

Unilabs is a diagnostic services company that operates more than 120 laboratories and 44 radiology units in Denmark, Finland, France, Italy, Norway, Portugal, Russia, Spain, Sweden, Switzerland, and the UK.