Qiagen Gets CE Mark for HPV Test - Analyst Blog

Recently, Qiagen (QGEN) received the CE Mark for its care human papillomavirus (HPV) test. The certification implies that the test has met the required norms in the EU thereby, enabling the company to distribute the test in developing regions that recognize the CE Mark.
 
As a result, Qiagen will be able to target the developing regions of India and Africa where there is a high prevalence of cervical cancer. While cervical cancer causes nearly 274,000 deaths every year, 88% happen in developing countries.
 
As per estimates of the World Health Organization (WHO), about 5% of women in the developing world have been screened for cervical diseases in the previous five years, compared to 40-50% in the developed world. This situation is alarming and demands immediate attention from the health authorities.
 
Qiagen is also planning to get WHO prequalification. This will allow United Nations (UN) agencies to procure the tests for low income countries. Additionally Qiagen plans to submit a marketing application for the care HPV test to the Chinese State Food & Drug Association (SFDA).

Qiagen’s portfolio of HPV tests consists of digene HPV test which is considered to be the most efficient and effective solution for laboratory-based testing. The care HVT test makes the process simpler, effective and affordable for women in developing regions. This test has other advantages as well; it can be performed even without electricity or running water and detection results can be made available within a few hours.

While care HPV test is targeted at the developing world, Qiagen is also working on the QIAensemble system which is a next generation HPV DNA testing platform targeted at sophisticated high throughput labs. This test is aimed at increasing the speed, volume and testing menu of the company's leading Hybrid Capture 2 system.

Qiagen’s assays for HPV represent a solid base for growth in the women’s health market.
 
In September 2009, the company had entered in a collaboration agreement with Merck (MRK) to increase access to HPV vaccination and HPV DNA testing in some of the most backward areas of the world.  While Merck intended to provide, for free, up to 5 million doses of its cervical cancer vaccine, Gardasil, Qiagen intended to add to its existing one million test donation program by providing HPV DNA tests to screen an additional 500,000 women.