CareHPV Test, a diagnostic for high-risk human papillomavirus (HPV), designed to screen women in low-resource settings, won the World Health Organization (WHO) pre-qualification on Wednesday.
The test costs five dollars, a tenth the price of the latest digene HC2 HPV Test.
WHO pre-qualification recognizes that the careHPV Test can help screen women in developing countries for HPV.
Except for the lower cost, the careHPV test takes only three hours, which is much shorter than the seven-hours digene HC2 HPV Test. The careHPV does not require standard laboratories, and all the reagents used in careHPV do not need to be refrigerated, which is convenient for rapid batch testing.
CareHPV Test was developed by Professor Qiao Youlin and his team from the Chinese Academy of Medical Sciences’ Cancer Hospital with support from PATH, an international nonprofit organization. They conducted a five-year research in five Chinese counties with scarce resources and high rates of cervical cancer, screening more than 11,000 women.
In 2012, the careHPV Test was manufactured by QIAGEN in Shenzhen, China, and adopted by thousands of Chinese hospitals. The WTO recognition will help developing countries with no ability to audit this test get purchase approvals.
Statistics show that 80% of new cases and deaths of HPV occur in developing countries, where awareness of the disease and access to screening tests and medical treatment is low.
“To achieve higher coverage of at-risk women and to have an impact in cervical cancer prevention, we need to move to affordable and cost-effective strategies with HPV testing, leveraging the self-sampling potent,” Dr. Silvia de Sanjosé, director of the Scale-Up project at PATH, said in QIAGEN’s press release blog.
The careHPV Test’s sensitivity is 89.7%, which is slightly lower than the digene HC2 HPV Test, the world’s most validated and sensitive HPV detection test. QIAGEN acknowledges it as being “highly complementary to the digene HC2 HPV Test.”
Cervical cancer is the fourth most common cancer among women worldwide. The WTO promotes screening and early diagnosis worldwide, though the launch of the HPV vaccine has made cervical cancer more preventable and controllable. Based on previous practices in the West, the incidence of cervical cancer was reduced by 70 to 90 percent among those screened.
(Compiled by Xu Yanan)