QIAGEN welcomes change of a major U.S. guideline to recommend HPV testing as part of cervical cancer screening
- U.S. Preventive Services Task Force (USPSTF) changes its recommendation to support HPV screening in conjunction with cytology (Pap test) for cervical cancer protection
- Other U.S. organizations, including American Cancer Society and leading professional groups, reaffirm guidelines supporting benefits of co-testing with HPV and Pap tests
- More than 80 million digene HPV Tests shipped worldwide to date, and over 1 million women involved in post-market, peer-reviewed studies
- Significant unmet medical need: About half of women diagnosed with cervical cancer in U.S. never had Pap or adequately screened
Germantown, Maryland, and Hilden, Germany, March 15, 2012 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today welcomed a significant change to a national guideline in the United States that underscored the benefits of its digene HPV Test as part of cervical cancer screening protection in combination with traditional cytology (Pap test).
The final report of the U.S. Preventive Services Task Force (USPSTF) issued a "Grade A" recommendation in favor of co-testing women age 30 to 65 every five years with HPV (human papillomavirus) and Pap tests as the preferred alternative to a Pap test alone on a three-year basis. This was a reversal from a draft proposal issued in October 2011 with a "Grade I" recommendation stating that the benefits of HPV testing needed to be reviewed through further testing.
In addition, the report cited QIAGEN's digene HPV Test as being "commonly used" for HPV testing, noting that "although alternative HPV detection methods are emerging, the clinical comparability and implications of these methods are not completely understood."
QIAGEN further welcomed the reaffirmation of prior cervical cancer screening guidelines issued by other U.S. organizations including the American Cancer Society, the American Society of Colposcopy and Cervical Pathology (ASCCP) and the American Society for Clinical Pathology. These guidelines state that testing with both Pap and HPV tests is preferable to Pap testing alone. The guidelines were issued in advance of the biennial ASCCP meeting in San Francisco.
"The key to reducing the burden of cervical cancer is to improve screening, and the clear views of these organizations is for women in the relevant age groups to receive co-testing with cytology and HPV testing," said Dr. Ellen E. Sheets, Chief Medical Officer of QIAGEN. "Co-testing has been demonstrated to be more effective than Pap tests alone based on data showing that QIAGEN's HPV DNA test is more accurate than cytology alone. These guidelines reaffirm our commitment to continue working with physicians and other healthcare providers to encourage co-testing to give women and their physicians an early warning of the threat of cervical cancer. We are convinced that these guidelines will help drive the momentum to shift toward co-testing in the U.S. and further reduce the often-fatal burden of cervical cancer."
HPV is the primary cause of cervical cancer. QIAGEN's digene HPV Test uses the proven hybrid capture (HC2) technology that is the basis for the most clinically validated threshold detection method for high-risk HPV and is the market-leader for HPV testing. QIAGEN has worked closely with physicians and laboratories to encourage co-testing with cytology and the digene HPV Test.
The digene HPV Test is the market-leading FDA-approved molecular test for HPV screening based on annual sales. It is considered the "gold standard" in terms of performance and validation, supported by clinical data in independent, peer-reviewed publications involving more than 1 million women. More than 80 million digene HPV Tests have been delivered worldwide since its market introduction in 1997.
The unique HC2 technology employed in the digene HPV Test has demonstrated significant benefits - most importantly superior clinical sensitivity in identifying women with HPV infections that place them at high risk for cervical cancer. Based on publicly available data, QIAGEN believes that no other test has been able to match the power of the digene HPV Test to detect infections that put women at risk for cervical cancer. The digene HPV Test is indicated both for co-testing with cytology to screen women age 30 and older as well as to determine the need for colposcopy/biopsy referral for women with borderline abnormal cytology results (ASC-US).
"The digene HPV Test with its proven clinical threshold, focuses on telling clinicians whether each patient is relevantly infected with one or more of 13 high-risk strains of HPV," Dr. Sheets said. "If the patient has a high-risk HPV infection, clinical guidelines call for follow-up care that is essentially the same regardless of which particular strain is detected."
The value of molecular HPV testing is increasingly recognized in treatment guidelines around the world. Many countries have established or are evaluating co-testing, primary screening with HPV alone, or reflex HPV testing as a cornerstone of cervical cancer prevention programs, based on QIAGEN's digene HPV Test data. With about 500,000 new cases and 300,000 related deaths annually around the world, cervical cancer is the second most frequent cancer in women. Early detection has been proven to reduce the burden of this disease, as cervical cancer can be effectively treated if found in its early stages.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of December 31, 2011, QIAGEN employed approximately 3,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com/.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).