Qiagen has announced the commercial launch in India of its careHPV test, the only molecular diagnostic for high-risk human papillomavirus (HPV) designed to screen women in settings with limited healthcare infrastructure, such as areas lacking electricity, water or laboratories.
The careHPV Test was launched commercially in China in 2013 and has been used in several other countries, including as part of Qiagen’s corporate social responsibility effort, Qiagencares.
The careHPV test for low-resource settings is highly complementary with Qiagen’s digene HC2 HPV test, the world’s most validated and sensitive diagnostic test for detection of high-risk HPV. The digene HC2 HPV Test is recognized as the ‘gold standard’ in HPV screening and is widely used in developed countries and in large cities in emerging markets.
Qiagen Asia Pacific president Dr Victor Shi noted the launch of careHPV in India will help in efforts to reduce the high burden of cervical cancer for women in India.
"With the digene HC2 HPV Test serving areas that have modern healthcare infrastructure and the careHPV Test serving low-resource areas, QIAGEN is expanding our role as the global leader in preventive screening for cervical cancer and continuing to contribute to women’s health around the world," Dr Shi added.
Qiagen’s robust, portable and easy-to-use careHPV Test combines the power of advanced molecular technologies with innovative design and features. For example, the system has color-coded, easy-to-understand menus and self-contained reagents.
he test tolerates temperature variations that occur in rural clinics lacking refrigeration for sample storage due to limited electricity or water, and can provide results much faster. The careHPV Test was developed with support from PATH, an international nonprofit organization, and is manufactured by QIAGEN in Shenzhen, China.
The careHPV Test already plays an important role in QIAGENcares, Qiagen’s collaborations with NGOs and governments in which it helps expand access to high-quality cervical cancer screening in resource-poor regions. For example, tests for cervical cancer have been conducted on women in El Salvador using the careHPV Tests since 2012. The test will also be used in other countries, including Vanuatu.
Also as part of QIAGENcares, Qiagen and the Chittaranjan National Cancer Institute (CNCI) started a five-year-program in 2010 to provide cervical cancer screening with the digene HC2 HPV Test to 50,000 women in rural West Bengal. Screening is facilitated through mobile field clinics.
This project has screened more than 36,000 women to date and has detected 216 cases of High Grade Squamous Intra-epithelial Lesions (HSIL) and 52 cases of cervical cancers. Most of the cervical cancers were at early treatable stages, and more than 90% of these patients have been treated at CNCI.
In addition, many doctors and community-based healthcare workers have been trained in HPV screening. This project is the first HPV based screening project in India, demonstrating program aspects and successful implementation with clear deliverables.