WOMEN of reproductive age in Nigeria are amongst 300,000 women in low-resource settings who stand to benefit from the findings of an eight-year trial on the effectiveness of a novel human papillomavirus (HPV) scanning kit.

Led by Dr. Rengaswamy Sankaranarayanan of the International Agency for Research on Cancer (IARC), the randomized, controlled trial compared the efficacy of three methods of cervical cancer screening - VIA, Pap testing (cytology) and HPV testing with a hybrid capture 2 DNA testing technology (called the digene HPV Test).

QIAGEN N.V., a Netherlands holding company and leading global provider of sample and assay technologies, develops and markets the digene HPV Test, which is regarded as the "gold standard" in testing for high-risk types of HPV.

The digene HPV Test trial, conducted in the Maharashtra state of India, with support and funding by the Bill & Melinda Gates Foundation, was used to detect high-risk types of HPV, in 130,000 women, to demonstrate that in low-resource settings, a single round of HPV testing significantly reduces the numbers of advanced cervical cancers and deaths, compared with routine Pap (cytology) testing or visual inspection with acetic acid (VIA).

Based on the outcome of this milestone study, QIAGEN will, over the next five years, donate one million HPV tests, with a total estimated value of over US$30 million as part of its broader global access programme to provide the highest quality cervical cancer screening technologies to women in developing countries. Nearly 300,000 women die of cervical cancer every year, mostly in developing countries,but QIAGEN's approved digene HPV Test specified for use with a Pap smear in women aged 30 and above, is expected to cut the attendant fatalities significantly.

In Nigeria, screening for cervical cancer is often difficult to achieve partly because of significant competing, urgent health-care needs, in particular the HIV epidemic, and partly because of poorly functioning health-care delivery systems.

Worldwide, cervical cancer affects approximately 500,000 women annually and, after breast cancer, is the second-most-common malignancy found in women. Since the cause of cervical cancer - HPV - is known and women who have it can be identified, it is a highly preventable and treatable disease if women have access to organized prevention programmes. Approved by the Federal drug Agency (FDA) of America since 1999, the digene HPV Test is reputed to have been published in more than 300 peer-reviewed journal articles and studied in clinical trials involving more than 825,000 women worldwide while more than 40 million tests for carcinogenic HPV have been performed with the digene HPV Test.

It is the first randomised controlled trial to measure incidence of cervical cancer and associated rates of death as the primary outcomes, using different tools for screening. In addition to being "associated with a significant reduction in the numbers of advanced cervical cancers and deaths from cervical cancer," QIAGEN's HC2 HPV testing platform was described as "the most objective and reproducible of all cervical cancer screening tests and was less demanding in terms of training and quality assurance."

Commenting on the development, Drs. Mark Schiffman and Sholom Wacholder of the U.S. National Cancer Institute noted: "The implications of the findings of this trial are immediate and global: international experts in cervical-cancer prevention should now adapt HPV testing for widespread implementation."

In their view: "The remarkable promise of the Indian trial presents a worthy global challenge to implement smart, regionally tailored strategies that will efficiently save millions of lives in the years ahead."

QIAGEN's commitment to expanded access to HPV screening includes HPV test donation programmes, in partnership with leading public health institutions and health non-governmental organizations (NGOs); development of next-generation HPV technologies, including the careHPV test - designed specifically for low-resource, developing countries and tiered-pricing initiatives for low-resource countries

Peer Schatz, Chief Executive Officer of QIAGEN also notes: "This landmark study further validates the value of QIAGEN's HPV test as the gold standard for cervical cancer screening and demonstrates that the incidence of advanced cervical cancer and deaths are actually reduced - and hence lives saved - when HPV screening is implemented."

Schatz added that Qiagen's HPV testing technology is already being used to routinely screen millions of women in the United States and Europe. "We're committed to working together with the public health community to ensure that women everywhere have access to the best cervical cancer prevention tools." QIAGEN will collaborate with a team of global health partners - including the International Planned Parenthood Federation and Jhpiego, an international non-profit health organization affiliated with Johns Hopkins University - on the administration of the donation programme.

This donation of one million HPV tests builds upon the company's programmes to increase access to HPV testing and cervical cancer prevention technologies for women worldwide through QIAGENcares, a corporate social responsibility programme to improve the access to better screening methods for infectious diseases in emerging and developing countries.

The World Health Organization estimates that only about 5 per cent of women in the developing world have been screened for cervical disease in the previous five years, compared to 40-50 percent in the developed world. For more information about HPV and cervical cancer.

But to ensure that HPV testing can reach women in all regions of the world, the company is working with PATH and the Bill & Melinda Gates Foundation to develop a new version of its state-of-the-art HPV test - to be called the careHPV test - for public-health programmes in low-resource, developing countries such as Nigeria.

The careHPV test, currently in development, can be performed without electricity or running water and offers HPV detection results in a matter of hours - a critical characteristic for women traveling to clinics from isolated villages and for those women who may need to be treated the same day. Both QIAGEN HPV screening technologies - careHPV and the digene HPV Test - are expected to play a key role in reducing cervical cancer worldwide. Both will be included in the donation programme.