Quidel : Quidel Announces Worldwide, Exclusive License for Novel DNA Microarray (MChip) for Global Influenza Surveillance

12/19/2006| 07:00am US/Eastern

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Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, today announced an exclusive, worldwide license to the MChip microarray-based influenza detection technology developed by scientists at the University of Colorado (CU) in close collaboration with the U.S. Centers for Disease Control and Prevention (CDC).

?We are extremely pleased with this licensing agreement with the University of Colorado and the CDC, as it strategically positions Quidel Corporation with an important technology and tool in the molecular diagnostic field," commented Caren Mason, president and CEO of Quidel Corporation. ?With the acquisition of this validated technology, Quidel looks ahead to expand its product range and reinforce its market leadership in rapid point-of-care influenza diagnostics,? added Mason.

Quidel's intent is to develop and market molecular-based diagnostic tests featuring the MChip for use in pandemic surveillance, as a tool for the clinical laboratory and at the point-of-care in the physician office laboratory.

The MChip offers several advantages over current molecular-based arrays for the detection of influenza viruses, including the recently disclosed FluChip developed by the same research team at the University of Colorado at Boulder and the CDC. While the majority of molecular-based arrays use sequences from three influenza genes -- hemagglutinin (HA), neuraminidase (NA) and matrix (M) -- the MChip exclusively exploits sequences from the matrix genes. Unlike HA and NA, which mutate constantly, the M gene segment is more conserved. A diagnostic test based on this relatively stable gene segment should be more robust because it will continue to provide accurate results even as the HA and NA genes mutate and will require less frequent reconfiguration. In addition, current molecular tests provide only information about the type of virus present in a single sample (i.e., Influenza type A or Influenza type B). The MChip offers the advantage of simultaneously typing and subtyping the flu virus in a single procedure (for example, Influenza type A, subtype H5N1), avoiding the need for additional subtyping of the virus.

As reported by CU, the MChip has been validated in collaboration with the CDC by testing H5N1 samples collected over a three-year period from people and animals around the world and to date has correctly identified 24 different H5N1 flu strains at 97% sensitivity and 100% specificity, with no reported false positives.

In a November 14, 2006 NIH press release, Dr. Nancy Cox, Director of the influenza division of the U.S. Centers for Disease Control and Prevention, stated the following: ?This new technology, once manufactured and distributed, could have the potential to revolutionize the way laboratories test for influenza. The MChip could enable more scientists and physicians, possibly even those working in remote places, to more quickly test for H5N1 and to accurately identify the specific strain and its features.?

Dr. Kathy Rowlen, Project Leader of the CU discovery team commented: ?We are delighted that Quidel has licensed the MChip technology. We see Quidel as the ideal company to bring this technology to health care providers and surveillance personnel around the world due to their established leadership in point-of-care diagnostics and reputation for high quality products.?

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the discovery, development, manufacturing and marketing of rapid diagnostic solutions at the point of care (POC) in infectious diseases and reproductive health. Marketed under the leading brand name of QuickVue®, the portfolio currently includes tests that aid in the diagnosis of several disease or condition states, including influenza, respiratory syncytial virus, Fecal Occult Blood, Strep A, pregnancy, bacterial vaginosis, infectious mononucleosis, H. pylori and Chlamydia. Quidel's products are sold to healthcare professionals with a focus on the physician office lab and acute care markets through leading medical distribution partners on a worldwide basis. Quidel's Specialty Products Group (SPG) develops research products in the fields of oncology and bone health with future point-of-care applications. By building value in rapid diagnostic tests, Quidel provides leadership to the industry and among healthcare professionals, allowing for the movement of patient testing out of the central laboratory setting and into the physician office, urgent care and other outpatient settings where rapid testing and treatment has an impact on clinical outcomes and provides an economic benefit. For more information, visit www.quidel.com, www.flutest.com or www.colorectal-test.com.

This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risk 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. As such, no forward-looking statement can be guaranteed. Differences in operating results may arise as a result of a number of factors including, without limitation, uncertainty with research technology development, including any future molecular based technology, seasonality, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration ("FDA"), intellectual property, product liability, environmental or other litigation, and the lower acceptance of our new products than forecast. 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 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.

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