Study Finds New Version of QIAGEN's HPV Test for Developing Countries Could Reduce Risk of Cervical Cancer by More than Half When Combined With Appropriate Treatment
- Research Shows the New Test is Accurate, Simple to Run andRequires Minimal Resources
Research demonstrating the potential of a special type of HPV testdeveloped by QIAGEN with support from PATH -- a non-profit globalhealth organization -- to reduce the incidence of cervical cancer inlow-resource regions of the world were presented this week at the24th International Papillomavirus Conference in Beijing, People'sRepublic of China. An economic modeling analysis found that the"FastHPV" test, which is being developed specifically for cervicalcancer screening in countries such as China and India, could reducethe incidence of cervical cancer by as much as 56 percent if givenjust three times over a woman's life and combined with appropriatetreatment. In addition, a clinical research study concluded that theFastHPV test produces rapid, accurate results, yet is also simple torun, requires minimal infrastructure and will be affordable forpublic-health programs in those countries.
FastHPV -- a molecular test for cancer-causing types of HPV (humanpapillomavirus) -- is under development by QIAGEN N.V. (Nasdaq: QGEN;Frankfurt, Prime Standard: QIA) in partnership with PATH. The test --on track to be submitted for its first regulatory approvals incountries like China and India in 2008 -- is specially designed toallow women in areas with scarce healthcare resources to benefit fromthe advanced technology of HPV testing.
"It is relatively common for healthcare companies to provide theirproducts and services at reduced prices to countries with minimalhealthcare infrastructure and large low-income populations," saysPeer Schatz, CEO of QIAGEN. "With our new FastHPV test, QIAGEN hasgone beyond that standard approach and has specifically adapted theHPV DNA test it sells in the developed world to meet the specialneeds of women and their healthcare providers in these verychallenging settings. What is remarkable is that while the FastHPVtest uses very advanced molecular diagnostic technologies, it ispackaged into a solution that can be run in almost any environmentand by almost any operator. QIAGEN is already the leader in moleculardiagnostics in the developed world, and we take very seriously ourcommitment to make improvements in life possible for everyone, nomatter what their socioeconomic status."
The FastHPV test can be conducted by workers with minimalhealthcare training and education. Once collected, samples of vaginalor cervical cells are prepared for analysis using a kit of reagentsthat contains its own water supply. The kit's stability has beendemonstrated for more than eight months at room temperature, andconditions as extreme as 104 degrees F. -- 40 degrees C. -- can betolerated for up to a month. The testing itself is conducted oneasily portable equipment and will, when introduced, run onbatteries.
Human papillomavirus is the primary cause of cervical cancer,which affects nearly 500,000 women around the world every year andkills more than 250,000 -- of which 80 percent are in developingcountries. The High-Risk hc2 HPV DNA Test(R) developed by DigeneCorp. (now part of QIAGEN) is emerging as a standard of care foridentifying women at risk. In the United States, HPV testing has beenapproved by the U.S. Food and Drug Administration for use along withcytology (commonly called the Pap smear) in women 30 and over.However, the infrastructure (such as clean water and electricity) andtrained personnel required for Pap smears are not usually feasiblefor low-resource regions.
In addition, in these regions, transportation and other obstaclesprevent easy access to medical clinics, necessitating rapidavailability of test results so that follow-up care -- if needed --can be initiated quickly, ideally the same day. FastHPV has beendesigned to be used as a stand-alone diagnostic test to screen womenfor cervical cancer risk, producing results in less than two and ahalf hours.
The first clinical study of FastHPV to be reported, which wassummarized at the conference in Beijing, was conducted as part ofPATH's Screening Technologies to Advance Rapid Testing (START)project. It involved more than 2,500 women age 30-54 in mostly ruralareas of China, where the World Health Organization has found thatdiseases are the cause of poverty for up to half of the population.Because cytology is not practical in such regions, the most commoncervical cancer screening tool has been visual inspection with aceticacid (VIA), in which the cervix is painted with vinegar to betterhighlight any abnormal areas present, then examined by a healthcareprofessional. However, in this study, VIA was not very accurate; itssensitivity (ability to identify women who have severe, pre-cancerouscervical disease) was only 41 percent. In contrast, the sensitivityof FastHPV was 86-90 percent when samples of cervical cells collectedby healthcare workers were used, and 72-81 percent when womencollected their own samples using a vaginal collection device.
"Unlike other cancers, cervical cancer has a single, known cause:HPV. That makes the disease highly preventable -- if abnormal cellsare found and treated early. This research clearly shows that theability of FastHPV to accurately identify women with pre-cancerouscervical disease is substantially better than visual inspection andapproaching that of the technology used for HPV DNA testing inhigh-resource countries (QIAGEN's proprietary hc2 platform),"concluded Professor Youlin Qiao, who led the China study and servesas Chief of the Department of Cancer Epidemiology at the ChineseAcademy of Medical Sciences. "FastHPV is very promising as arealistic method for public-health cervical cancer preventionprograms in low-resource settings like many areas of rural China."
In a separate presentation in Beijing, John Sellors, MD, SeniorMedical Advisor at PATH and START project director, discussed theresults of an economic model that projected the impact if women inlow-resource countries were to be tested with FastHPV just threetimes in their lives -- 5 years apart, after age 35. This analysisfound that cervical cancer could be reduced by 56 percent, assumingthat the majority of women participated and effective treatment isavailable. The best results would be achieved when using a"screen-and-treat" approach that allows women found to have the virusto be treated for possible disease in the same visit. Standardprotocols in North America and Europe call for women with a positiveHPV test to be re-screened later to confirm that the infection hasnot naturally resolved, and/or to confirm the presence of cervicaldisease with a biopsy. However, this is not feasible or affordable inlow-resource settings, and many women would fail to return for therequired follow-up visits.
Dr. Sellors and his colleagues add that while vaccination ofadolescents against the most common types of HPV would be expected toreduce the incidence of cervical cancer even further, itscost-effectiveness will depend on price and the ability to ensurecompliance with the necessary protocol, which currently calls forthree shots over six months.
About HPV and cervical cancer
Worldwide, cervical cancer affects nearly 500,000 women annuallyand, after breast cancer, is the second-most-common malignancy foundin women. Cervical cancer is caused by "high-risk" types of the humanpapillomavirus (HPV), which are sexually transmitted. It's estimatedthat 80 percent of women will get an HPV infection at some point intheir lives. However, in most cases, the infection goes away or issuppressed by the body without causing problems. It is onlyinfections that persist that can cause abnormal cells to form thatmay develop into cervical cancer if not detected and treated early.One report from the World Health Organization estimates that onlyabout 5 percent of women had been screened for cervical disease inthe previous five years, compared to 40-50 percent in the developedworld.
About PATH (www.path.org)
PATH is an international, nonprofit organization that createssustainable, culturally relevant solutions, enabling communitiesworldwide to break longstanding cycles of poor health. Bycollaborating with diverse public- and private-sector partners, PATHhelps provide appropriate health technologies and vital strategiesthat change the way people think and act. PATH's work improves globalhealth and well-being. Headquartered in Seattle, Washington, USA,PATH has 29 offices in 18 countries. PATH currently works in morethan 65 countries in the areas of health technologies, maternal andchild health, reproductive health, vaccines and immunization, andemerging and epidemic diseases.
About QIAGEN (www.qiagen.com)
QIAGEN N.V., a Netherlands holding company, is the leadingprovider of innovative sample and assay technologies and products.QIAGEN's products are considered standards in areas such aspre-analytical sample preparation and assay solutions for lifesciences, applied testing and molecular diagnostics. QIAGEN hasdeveloped a comprehensive portfolio of more than 500 proprietary,consumable products and automated solutions. The company's productsare sold to academic research markets, leading pharmaceutical andbiotechnology companies, applied testing customers (such as inforensics, veterinary, biodefense and industrial applications) andmolecular diagnostics laboratories. QIAGEN products are sold througha dedicated sales force and a global network of distributors in morethan 40 countries; the company employs more than 2,600 peopleworldwide. Further information about HPV DNA testing specifically canbe found at www.theHPVtest.com.
Web site: http://www.thehpvtest.com http://www.qiagen.com http://www.path.org
ots Originaltext: Qiagen N.V.Im Internet recherchierbar: http://www.presseportal.de
Contact:Pam Rasmussen, +1-240-506-0766, Pamela.Rasmussen@digene.com, or Thomas Theuringer, +49-2103-29-1826, Thomas.Theuringer@qiagen.com, both of QIAGEN (formerly Digene), or Sue-Lane Wood, PATH, +1-206-310-9121, firstname.lastname@example.org