New study confirms superior sensitivity of digene HC2 HPV DNA Test vs. the other FDA-approved tests for HPV
Sep 25 2014

New study confirms superior sensitivity of digene HC2 HPV DNA Test vs. the other FDA-approved tests for HPV

  • QIAGEN’s Hybrid Capture 2 technology detects 97.5% of moderate-to-severe HPV infections (CIN 2+), compared to 91.4% for the other two approved tests
  • A recent study from Mayo Clinic shows digene HPV Test has highest sensitivity in ruling out HPV disease, which can cause potentially deadly cervical cancer
  • QIAGEN’s HC2 test remains ‘gold standard’ in clinical screening for HPV infections

Germantown, Maryland, September 25, 2014 — A recently published study comparing three FDA-approved screening tests for human papillomavirus (HPV) provides the latest confirmation of superior sensitivity for QIAGEN’s digene HC2 HPV DNA Test. HPV is the primary cause of cervical cancer, a cancer that can be deadly when the disease goes undetected and untreated.

The study at Mayo Clinic compared the performance of FDA-approved HPV tests on 350 women with inconclusive or abnormal PAP (≥ ASC-US) using biopsy results as the reference standard. Biopsy results of the 350 patients found 81 cases to have moderate to severe HPV related disease (CIN2+). Of these cases the digene HPV Test correctly identified 97.5% of the CIN 2+ patients, while the other FDA-approved tests each only correctly identified 91.4% of the CIN 2+ infections.

“The digene HPV Test is the world's most proven tool for sensitive, early detection of high-risk HPV, and the latest study confirms the benefits which are demonstrated in more than 300 previous peer-reviewed articles,” said Dr. Tadd Lazarus, Chief Medical Officer of QIAGEN. “QIAGEN’s HC2 technology has been evaluated in clinical trials involving more than 1 million women – and proven through 15 years of clinical practice and more than 90 million tests worldwide using the digene HPV Test. Co-testing with Pap smears and our HC2 technology has proven to be up to 100% sensitive for detection of CIN 2+ HPV.”

Dr. Patricia Braly, a nationally recognized gynecologic oncologist at Women’s Cancer Care in Covington, Louisiana, commented: “Sensitivity is the key in selecting an HPV test, because the goal of screening is to rule out HPV disease with a high level of confidence – and to identify patients in need of more evaluation and treatment. With the time between screenings now extending to five years for many women, we cannot afford the risk of ‘false negatives’ that miss patients who may have CIN 2+ disease – or even cervical cancer. This is why my clinic relies on examination and co-testing with the Pap smear and digene HPV Test to protect our patients.”

Cervical cancer affects worldwide approximately 500,000 women annually and is the second-most-common malignancy in women after breast cancer. The cause of cervical cancer is the human papilloma virus (HPV), and women who have HPV infections can be identified. Cervical cancer is highly preventable and treatable.

The digene HPV Test, is the unrivalled "gold standard" in testing for high-risk types of HPV The digene test uses advanced Hybrid Capture 2 technology to directly detect the presence of 18 types of HPV and is the only HPV assay that examines the entire length of the genome, which helps prevent false negatives caused by gene deletions that occur naturally during a woman’s biological integration of the HPV virus. When the digene HPV Test rules out high-risk HPV, the result is highly reliable, based on the higher sensitivity of the HC2 technology. This benefit is seen to be of critical value in screening settings, in particular as intervals between screenings are extended.

The new paper was published in the October 2014 Journal of Clinical Microbiology (see abstract online).

About QIAGEN

QIAGEN N.V., a Netherlands-based 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 June 30, 2014, QIAGEN employed approximately 4,200 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).

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