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QIAGEN Welcomes Change Of A Major U.S. Guideline To Recommend HPV Testing As Part Of Cervical Cancer Screening

GERMANTOWN, Maryland and HILDEN, Germany, March 15, 2012 /PRNewswire/ --
  • 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

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.  


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