Researchers Say Identification of Women with HPV Types 16, 18 and 45 Could Improve Early Intervention to Stop Cervical Cancer
Nov 14 2008

Researchers Say Identification of Women with HPV Types 16, 18 and 45 Could Improve Early Intervention to Stop Cervical Cancer

Results Presented for Genotyping Tests Now Under Development by QIAGEN

Nice, France - Nov. 14, 2008 -- As testing for high-risk types of the human papillomavirus (HPV) emerges as the gold standard in cervical cancer prevention, scientists are already researching how to determine even more precisely who is most likely to develop the disease and thus are in need of more immediate intervention. Speaking at the EUROGIN (European Research Organization on Genital Infection and Neoplasia) conference this week, experts presented data suggesting that the most effective strategy would be to introduce a second test to determine if women who test positive for high-risk HPV have one of three types of the virus that are associated with the highest mortality from cervical cancer: 16, 18 and 45.

About 30 HPV types are spread through genital contact, and about 18 of these can potentially cause cervical cancer. Each is "named" with a number, in the order of their discovery. Much attention has been paid to types 16 and 18, which account for 70 percent of all cervical cancers and against which the new HPV vaccines protect. However, experts say that medical evidence shows that type 45 should be a priority concern as well.

"Most of the focus has been on HPV types 16 and 18, because they are the most prevalent carcinogenic HPV types and are targeted by the new HPV vaccines," comments Attila Lorincz, PhD, one of the originators of the HPV test and Professor at Barts and The London School of Medicine. "However, type 45 also is highly associated with risk, particularly for adenocarcinoma, a very aggressive type of cervical cancer with a mortality rate of 52% after five years -- twice the rate of squamous-cell cancers. The incidence of invasive cervical adenocarcinoma, which used to account for 10-15 percent of all cervical cancers, has been steadily increasing - in part because it develops inside the cervical canal and thus is difficult to detect early using a Pap smear."

Currently, there is one HPV test, developed by QIAGEN (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA) and marketed as the digene HPV Test, which is approved by the U.S. Food and Drug Administration and is CE-marked in Europe. When used for screening, it is given to women over the age of 30 along with a Pap test, which can find abnormal cells but cannot detect HPV directly. And now, QIAGEN is developing two types of follow-up tests that will identify specifically which types of the virus are carried by HPV-positive women. At EUROGIN this week, QIAGEN scientists are presenting the results of research showing the accuracy of the company's digene HPV Genotyping PS Test, which specifically identifies the presence of types 16, 18 and 45. This assay is based on the technology used in QIAGEN's front-line HPV screening test, Hybrid Capture 2 (HC2) - currently the gold standard in the field. In addition, data are being presented for a second QIAGEN assay, the digene HPV Genotyping RH Test, which identifies 18 types of potentially carcinogenic HPV. Prior to receiving CE marking in Europe, the genotyping tests will be made available for research use by laboratories and physicians exploring their potential clinical benefits. First to be available will be the digene HPV Genotyping RH Test, which is expected to be launched by the end of this year.

Currently, women who screen positive for high-risk HPV, but have normal Paps, are brought back for re-testing 12 months later, since it is only persistent infections that cause cancer. However, Dr. Lorincz explains that genotyping would allow women with HPV 16, 18 or 45 -- who are at highest risk of cervical cancer -- to be immediately examined further for the presence of pre-cancerous or cancerous cells.

"QIAGEN is committed to remaining the leader in the fight to eliminate cervical cancer, by continuing to innovate and introduce new tools to fine tune our ability to single out women most in need of intervention," says Peer Schatz, CEO of QIAGEN. "We look forward to partnering with labs and physicians to further research the development of this advanced technology for identification of the most highly carcinogenic types of HPV -- 16, 18 and 45."

* "A Highly Specific HPV 16, 18 and 45 Reflex Test for the HC2 Assay," presented by Sameera Rangwala et al of QIAGEN Gaithersburg Inc.

** A Novel Consensus High-Risk HPV Genotyping Test for GPS 5+/6+PCR Products," presented by Geraets D et al of DDL Diagnostics Laboratory and the Department of Pathology, VU University Medical Center, Amsterdam.



QIAGEN N.V. is the leading global provider of sample and assay technologies, with its global headquarters in the Netherlands. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue, and assays make these isolated molecules visible to facilitate such vital activities as biological research and detection of disease. QIAGEN has developed and markets more than 500 products as well as instruments that make their use more efficient and accurate. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide, including the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 2,900 people in over 30 locations worldwide.


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