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Quidel's QuickVue(R) iFOB Test Results Show High Correlation with Quantitative Laboratory Assay for Fecal Occult Blood Using Stools from Patients with Post-Colonoscopy Based Clinical Diagnosis

SAN DIEGO--(BUSINESS WIRE)--Dec. 9, 2008--Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, presented data from a correlation study for its QuickVue iFOB (immunochemical Fecal Occult Blood) test for colorectal cancer (CRC) screening. The results demonstrated a high correlation between Quidel's POC immunochemistry test and a quantitative laboratory test for fecal occult blood. The study, entitled "A New Method for Quantification of FOB Levels," was introduced at the Colorectal Congress in St. Gallen, Switzerland on December 4th.

Two hundred stool specimens obtained from patients averaging 40 days post colonoscopy were examined in a quantitative test employing surface plasmon resonance, which measures the binding of hemoglobin to specific anti-human hemoglobin monoclonal antibodies. Using these post-colonoscopy stool specimens provided a potential quantitative cutoff for distinguishing patients with normal colons from those with cancer. The exact same specimens were then tested using the rapid QuickVue iFOB test.

The quantitative laboratory method gave negative readings for 96 percent (45/47) of samples from patients with normal colons and positive readings for 82 percent (27/33) of stool samples from patients with colorectal cancer. When the same samples were tested using QuickVue iFOB, the qualitative test detected 96 percent (26/27) of stools positive for quantitatively elevated hemoglobin from confirmed cancer patients based on the selected quantitative laboratory method cutoff. The QuickVue iFOB test correctly called as negative 89 percent (40/45) of the stool specimens identified by the quantitative laboratory test as not having significantly elevated hemoglobin from confirmed normal patients.

"This high correlation with a quantitative laboratory method is an important step to further delineate the clinical and economic benefits of POC fecal occult blood testing. In a time of profoundly rising health care costs, the need for less expensive, reliable methods for detection of disease is clear. Rapid point-of-care tests, such as Quidel's QuickVue iFOB test, is one such example," said Caren Mason, president and CEO of Quidel.

The QuickVue iFOB test is an FDA-cleared and CLIA-waived rapid immunochemical diagnostic tool intended for the detection of blood in stool specimens. Blood in the stool is an indication of a number of gastrointestinal disorders, including colorectal cancer. The QuickVue iFOB test provides results in 5 to 10 minutes and requires only one specimen. It is specific to human hemoglobin, and patients are not required to adhere to strict dietary or medication restrictions prior to testing.

The American Cancer Society recommends, as one method of screening, an annual fecal occult blood test1 for the estimated 91 million individuals ages 50 and older to assist in the early detection of colorectal cancer.2 The guidelines also recommend annual screening for those in the general population who are 50 years and older.

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(R), Quidel's portfolio of products 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, 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 potential 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.flutest.com, www.quidel.com, or www.colorectal-test.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. 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, the cutoffs selected in connection with the quantitative laboratory method ultimately do not correlate with larger population size or alternate testing methods, seasonality, the timing of onset, length and severity of cold and flu seasons, uncertainty surrounding the detection of novel influenza viruses involving human specimens, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors and the level of success in our recent distributor incentive programs, technological changes and uncertainty with research and technology development, including any future molecular-based technology, the reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"), intellectual property, product liability, environmental or other litigation, required patent license fee payments not currently reflected in our costs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated sales or market penetration of our new products. 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.

1 American Cancer Society

2 U.S. Census data

CONTACT:
Quidel Corporation
John Radak, Chief Financial Officer, 858-552-7962 or
Porter Novelli Life Sciences
Shirley Chow, 212-601-8308
schow@pnlifesciences.com

Source: Quidel Corporation