NEW YORK – Roche announced on Tuesday that it has been awarded World Health Organization Prequalification for an assay to detect human papillomavirus, a leading cause of cervical cancer.
More than 340,000 people globally died of cervical cancer in 2020 and 90 percent of these deaths occurred in low- and middle-income countries, according to the WHO.
WHO prequalification expands the availability of the Roche Cobas HPV test in countries that use the WHO prequalification list in making purchasing and implementation decisions, potentially enabling more LMICs to use the test as part of their national cancer screening programs.
"The elimination of cervical cancer is within reach," said Roche Diagnostics CEO Matt Sause. "Roche is committed to working with governments, nonprofit organizations, and funders to help build sustainable cervical cancer elimination programs so that women, no matter where in the world they live, no longer die from this preventable disease."
Prequalification combined with Roche's recently launched CE-marked HPV-self sampling solution further expands access to HPV screening in countries with limited healthcare resources, Sause also said.
The Roche Cobas HPV test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. It is indicated for use for routine cervical cancer screening, including HPV primary screening, co-testing with cytology, and for triage of women with abnormal cytology to assess the risk for cervical precancer and cancer.
The Cobas HPV test is also part of the Roche Global Access Program, which aims to improve access to cost-effective resources and contribute to the elimination of diseases in the regions with the greatest need.