Quidel Corporation Wins Two FDA Clearances for Molecular Diagnostic Tests
Published: Sep 16, 2013
Quidel Receives Two FDA Clearances for Molecular Diagnostic Tests for Use on Life Technologies QuantStudio(TM) Dx
CARLSBAD, CA and SAN DIEGO, CA--(Marketwired - September 16, 2013) -
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.
(2) Probable person to person transmission of novel avian influenza A (H7N9) virus in Eastern China, 2013: epidemiological investigation. BMJ 2013; 347.
(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. For more information about Quidel's comprehensive product portfolio, visit www.quidel.com and Diagnostic Hybrids at www.dhiusa.com.
This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation, fluctuations in our operating results resulting from seasonality; the timing of the onset, length and severity of cold and flu seasons; government and media attention focused on influenza and the related potential impact on humans from novel influenza viruses; adverse changes in competitive conditions in domestic and international markets; the reimbursement system currently in place and future changes to that system; changes in economic conditions in our domestic and international markets; changes in sales levels as it relates to the absorption of our fixed costs; lower than anticipated market penetration of our products; the quantity of our product in our distributors' inventory or distribution channels and changes in the buying patterns of our distributors; our development of new technologies, products and markets; our development and protection of intellectual property; our reliance on a limited number of key distributors; our reliance on sales of our influenza diagnostics tests; our ability to manage our growth strategy, including our ability to integrate companies or technologies we have acquired or may acquire; intellectual property risks, including but not limited to, infringement litigation; limitations and covenants in our senior credit facility; that we may incur significant additional indebtedness; our need for additional funds to finance our operating needs; volatility and disruption in the global capital and credit markets; acceptance of our products among physicians and other healthcare providers; competition with other providers of POC diagnostic products; changes in government policies; adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"); compliance with other government regulations, such as safe working conditions, manufacturing practices, environmental protection, fire hazard and disposal of hazardous substances; third-party reimbursement policies; our ability to meet demand for our products; interruptions in our supply of raw materials; product defects; business risks not covered by insurance; the loss of key personnel; international risks, including but not limited to, compliance with product registration requirements, exposure to currency exchange fluctuations, longer payment cycles, lower selling prices and greater difficulty in collecting accounts receivable, reduced protection of intellectual property rights, political and economic instability, taxes, and diversion of lower priced international products into US markets; our failure to maintain adequate internal control over financial reporting; volatility in our stock price; dilution resulting from future sales of our equity; and provisions in our charter documents and Delaware law that might delay stockholder actions with respect to business combinations or the election of directors. Forward-looking statements typically are identified by the use of terms such as "may," "will," "should," "might," "expect," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. The risks described under "Risk Factors" in reports and registration statements that we file with the Securities and Exchange Commission (SEC) from time to time should be carefully considered. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this press release. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.
About Life Technologies
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company that is committed to providing the most innovative products and services to leading customers in the fields of scientific research, genetic analysis and applied sciences. With a presence in more than 180 countries, the company's portfolio of 50,000 end-to-end solutions is secured by more than 5,000 patents and licenses that span the entire biological spectrum -- scientific exploration, molecular diagnostics, 21st century forensics, regenerative medicine and agricultural research. Life Technologies has approximately 10,000 employees and had sales of $3.8 billion in 2012.
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