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Quidel Corporation and Cholestech Corporation Partner to Offer ''Derm Kit'' to Help Dermatologists Achieve iPLEDGE(TM) Compliance
SAN DIEGO--(BUSINESS WIRE)--Feb. 22, 2007--Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, and Cholestech Corporation have joined forces to offer an exclusive "Accu-Tame" program to dermatologists designed to ease the cumbersome process of prescribing isotretinoin for their patients, while helping them comply with iPLEDGE(TM) pregnancy testing requirements as well as lipids and liver enzymes as recommended by the manufacturer.
The iPLEDGE program is a computer-based risk management program designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA. The program strives to ensure that:
-- No female patient starts isotretinoin therapy if pregnant; and
-- No female patient on isotretinoin therapy becomes pregnant.
While highly effective for severe acne, isotretinoin carries a significant risk of birth defects if taken during pregnancy, according to the U.S. Food and Drug Administration. In addition, isotretinoin can raise the level of fats and cholesterol in the blood, and can lead to elevations of liver enzymes.
Given the strict testing requirements associated with isotretinoin, Quidel and Cholestech decided to join forces to offer the "Accu-Tame" kit for prescribing physicians - primarily dermatologists. For the doctor and patient, the kit offers a "one stop shop" for pregnancy, lipid and liver tests.
The kit contains:
-- One box of QuickVue(R) One-Step hCG Urine (25-tests) from Quidel, for early detection of pregnancy;
-- One Cholestech LDX(R) System, which delivers rapid results for lipids, glucose and liver enzymes;
-- Five boxes of lipid profile test cassettes;
-- Five boxes of ALT/AST test cassettes (enzymes to monitor the liver); and
-- One box of Multi-Analyte Controls from Cholestech.
"Many patients can benefit from the use of Accutane but their health must be protected with regular monitoring. Providing dermatologists with a comprehensive kit that provides real-time diagnostic tools for use during office visits creates a win-win situation for both doctors and patients. The urine hCG test kits provided, coupled with the LDX, have helped make this Dermatology Kit a convenient all-in-one resource for doctors," said Warren E. Pinckert II, Cholestech president and CEO.
Quidel's QuickVue hCG tests, which outsell the nearest competitor nearly 3 to 1, are CLIA-waived for urine samples and offer a quick and convenient method to meet the pregnancy testing requirements associated with the iPLEDGE program.
"Quidel is devoted to promoting excellence in diagnostic testing," said Caren Mason, president and CEO of Quidel. "This partnership with Cholestech is an extension of our commitment to providing value-based programs and is demonstrative of our QVB(TM) (Quidel Value Build) strategy."
The FDA reports that as of November 30, 2006, more than 244,000 patients had registered on iPLEDGE since the program was opened for patient registration on December 31, 2005.
For more information, please visit https://www.ipledgeprogram.com/ or http://www.cholestech.com/products/ad-accutane.htm.
About Quidel Corp.
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, 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 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.quidel.com, www.flutest.com, or www.colorectal-test.com.
Cholestech is committed to enabling people to lead longer, healthier and more active lives. Cholestech provides easy to use, accessible diagnostic tools and information to health care practitioners in over 35 countries around the world. Cholestech offers efficient and economic diagnostic testing for cholesterol and related lipids, blood glucose and glycemic control, and liver enzymes at the point of care. Health care providers can use the CLIA-waived Cholestech LDX(R) and GDX(TM) Systems and the hs-CRP test, which is cleared by the FDA for use in moderate complexity labs, to initiate and monitor the progress of patient therapy. By providing effective disease management solutions, Cholestech's goal is to be a leading provider of diagnostic tools and information for immediate risk assessment and therapeutic monitoring of heart disease and diabetes.
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, 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.
CONTACT: Quidel Corporation
John Radak, Chief Financial Officer, 858-552-7962
Lippert/Heilshorn & Associates
Don Markley/Bruce Voss, 310-691-7100
SOURCE: Quidel Corporation