FDA Clearance Recieved For QuantStudio Dx Molecular Diagnostic Tests
17 Sep 2013

Quidel Corporation and Life Technologies Corporation announced yesterday that the United States Food and Drug Administration (FDA) has granted 510(k) clearances to the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV + hMPV assay, both for use on the QuantStudio™ Dx Real-Time PCR Instrument by Life Technologies.

The QuantStudio™ Dx is Life Technologies' flagship instrument for the diagnostics market, offering the advanced capabilities in flexible sample batching needed by higher-volume hospital and reference laboratories. The two 510(k) clearances add to the infectious disease menu available on the QuantStudio Dx instrument with assays for the diagnosis of some of the more common respiratory tract infections that often share similar influenza-like symptoms (ILI) and that can be difficult to distinguish, based on clinical signs and symptoms alone.

The Quidel Molecular Influenza A+B assay reports the presence or absence of influenza A and/or B virus; it does not differentiate influenza A subtypes. However, importantly, this molecular assay does demonstrate the analytical detection of subtype H7N9. The H7N9 subtype has caused more than one hundred infections to date in China, with a mortality rate of approximately 30 percent.1 Transmission of H7N9 infections to date have been as a result of human exposure to infected poultry, but a possible case of human-to-human transmission was recently reported in the British Medical Journal.2

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

The Quidel Molecular RSV + hMPV assay detects the presence of respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV). RSV is a respiratory virus that infects the lungs and breathing passages, and although most RSV infections are generally mild, some infections can be severe, especially among young children, the immunocompromised and the elderly. According to the Centers for Disease Control and Prevention (CDC), between 25% to 40% of infants and children exposed to RSV for the first time show signs or symptoms of bronchiolitis or pneumonia, and up to 2% may require hospitalization.3 hMPV was recently identified in 2001, and accounts for approximately 7.1% of respiratory tract infections.4 The virus appears to be distributed worldwide and by the age of five, virtually all children have been exposed to hMPV.5 Like RSV, hMPV generally causes mild respiratory tract infection, but can be severe, especially among young children, the immunocompromised and the elderly.
 

The Quidel Molecular Influenza A+B and RSV + hMPV assays are part of Quidel's expanding line of molecular diagnostics products. Quidel's product line offers PCR reagent kits that are designed to be used with a molecular laboratory's existing thermocycling infrastructure, effectively requiring no additional capital commitment on the part of the customer. These molecular kits provide attractive features that include refrigerated storage instead of freezing, ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcomes. Because most Quidel Molecular assays share a common extraction protocol, the RSV and hMPV Assay can be performed using the same extracted RNA as the Quidel Molecular Influenza A+B Assay.

"Every day, we're hard at work developing products like our Quidel Molecular RT-PCR assays that can offer our customers several unique benefits," said Douglas Bryant, president and chief executive officer of Quidel Corporation, who also added, "We are pleased to have our Quidel Molecular assays FDA-cleared to run on Life Technologies' cutting-edge diagnostic instrument and are excited to provide healthcare professionals with easy-to-use, high-performance assays that aid in the diagnosis of human infectious diseases."
Combining multiple system capabilities in a single footprint, Life Technologies' QuantStudio™ Dx provides a touch screen, reagent and sample tracking, and LIMS (Laboratory Information Management Systems) interface specifically designed for ease of use in diagnostic laboratories.

Flexibility is enabled through an optional Test Development mode allowing the use of readily interchangeable thermal cycling blocks that accommodate 96- or 384-well plates and a proprietary qPCR microfluidics card, which can perform 48 tests on eight samples simultaneously without need for liquid-handling robots. The card can also be used to design and implement custom tests. The Test Development mode is for Research Use Only. Not for use in diagnostic procedures.

"Our partnership with Quidel constitutes a key component of our strategy to expand our presence in the diagnostics space," said Ronnie Andrews, president of genetic analysis and medical sciences at Life Technologies. "We will continue to pursue the opportunity to partner to add content to our FDA Cleared systems in key disease areas."

The Quidel Molecular Influenza A+B and RSV + hMPV assays and QuantStudio™ Dx will be sold and distributed by both Quidel and Life Technologies in the United States, as well as in Europe. Both the assays and instrument are CE-IVD marked for diagnostic use in Europe.

The assays were previously 510(k)-cleared by the FDA for use with Life Technologies' Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and Cepheid's SmartCycler II.

1 http://www.who.int/csr/don/2013_08_11/en/index.html

2 Probable person to person transmission of novel avian influenza A (H7N9) virus in Eastern China, 2013: epidemiological investigation.BMJ 2013; 347.

3 http://www.cdc.gov/rsv/about/infection.html

4 Sloots T.P. et al. 2006 EID. 12:1236-66.

5 Ebihara, T. et al. 2004 J Med Virol 70:281-283.

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Sofia® and AmpliVue® brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories.

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Sonia Nicholas
Clinical Diagnostics Editor