Global launch of CE marked careHPV and new CE marked self-collection claim for HPV sampling device help to provide HPV screening for women most in need
HILDEN, Germany, 17-9-2015 — /EuropaWire/ — QIAGEN N.V. today announced its latest initiative to increase global access to advanced cervical cancer screening technologies for women most in need. It includes the commercial launch of QIAGEN’s CE marked careHPV Test and the introduction of a new CE marked self-collection claim for its sampling device, thedigene HC2 Collection Device.
The careHPV Test is the first HPV diagnostic specifically designed for regions with limited healthcare infrastructure. As such, the test enables the worldwide implementation and expansion of HPV-based cervical cancer screening, including in areas where women are not screened otherwise. Human papillomavirus or HPV is the primary cause of cervical cancer.
“Today, millions of women worldwide still lack access to proper cervical cancer screening programs. This results in more than 500,000 new cases of this disease and 270,000 associated deaths every year,” said Thierry Bernard, Senior Vice President and Head of Business Area Molecular Diagnostics at QIAGEN. “QIAGEN is pleased to continue its global, life-saving fight against this deadly disease by offering the careHPV Test to those women who need our help most. We know from our work in China, India and other countries that the careHPV Test makes a significant difference for women who wouldn’t be screened otherwise. We look forward to continuing to make that difference around the world and are excited by the added benefits the self-collection claim for the digene HC2 Collection Device will bring to our efforts.”
The robust, portable and easy-to-use careHPV Test and instrument are designed specifically for use in settings with a limited healthcare infrastructure, such as areas lacking electricity, water or laboratories. Due to the use of color-coding, easy-to-understand menus and self-contained reagents, non-medical staff can be trained to use the careHPV Test in a matter of hours. The test also tolerates temperature variations like those that can occur in rural, resource-poor areas without refrigeration. Its performance has been demonstrated in several clinical and demonstration trials in China, India, Nigeria and other countries. The careHPV Test was previously launched in India and China, and in other countries through QIAGENcares, the company’s social responsibility program, and was developed with support from PATH and the Bill and Melinda Gates Foundation.
The company also announced the introduction of a new CE marked claim for the digene HC2 Collection Device, allowing it to be used for self-collection of samples with its digene HC2 HPV Test, the world’s most validated and sensitive HPV test. The self-collection CE marked claim will also be launched for use with the careHPV Test during the fourth quarter of 2015. QIAGEN is the first company to offer both an HPV test and a collection device that are clinically validated for self-collected samples. The digene HC2 Collection Device was validated in a large study conducted in Mexico which showed that the sensitivity of the digene HPV Test on self-collected samples was three times greater than that of cytology.
After simple, one-time instruction from a medical professional, the brush-like device enables women to self-collect a sample for testing. As such, the digene HC2 Collection Device holds the promise to reach even more women and increase the efficiency of cervical cancer screening programs. The CE mark is recognized in many developing countries.
Cervical cancer is one of the world’s deadliest, yet most easily preventable cancers, according to the World Health Organization. While the incidence of cervical cancer is decreasing in the developed world, the opposite is true in the developing world. Cervical cancer is responsible for more than 270,000 deaths a year, 85 percent of which occur in developing countries, the WHO says. HPV screening is critical to global efforts to decrease the incidence and mortality of cervical cancer. However, many areas with the highest burden of cervical cancer lack the clean water, electricity or modern laboratories that are typically necessary for screening.
More information about the QIAGENcares program and the careHPV Test is available online at www.qiagen.com
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions to transform biological materials into valuable molecular insights. QIAGEN sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective molecular testing workflows. QIAGEN provides these workflows to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of June 30, 2015, QIAGEN employed approximately 4,400 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com
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