QIAGEN N.V. today 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. HPV is the primary cause of cervical cancer in women, so screening for the viral infection is a powerful strategy for prevention and early treatment of the deadly cancer. 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.
About 72,000 women in India die of cervical cancer each year, more than one-fourth of the world's 270,000 annual deaths. In India, cervical cancer accounts for about 20% of all cancer-related deaths in women and is the number one cause of death in middle-aged Indian women.
"The launch of careHPV in India will help in efforts to reduce the high burden of cervical cancer for women in India," said Dr. Victor Shi, President of QIAGEN Asia Pacific. "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. Partha Basu, Head of the Department of Gynecological Oncology and Officer In Charge, Division of Preventive Oncology, Chittaranjan National Cancer Institute, noted the importance of the two-tiered approach to screening: "Based on the findings of the screening project that we have been doing for four years in Kolkata and surrounding areas, there is a need for a cost-effective and easy-to-use test which can best meet the requirements of low-resource settings. Availability of the careHPV Test is an important step forward for the prevention of cervical cancer in India."
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. The 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.
Cervical cancer is the second most common cancer among women worldwide, and research has shown that 80% of new cases and deaths occur in developing countries, where awareness of the disease and access to preventive tests and medical treatment is low. In many low-resource areas, cervical cancer has eclipsed breast cancer as the primary cancer killer of women.