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Roche Molecular HPV Test Receives WHO Prequalification

NEW YORK – Roche announced on Thursday that its molecular Cobas HPV test has received prequalification designations from the World Health Organization.

The prequalification designations are for the test's use on the Cobas 5800 platform and for its use with self-collected samples on the Cobas 5800, 6800, and 8800 instruments. Last year, the test received WHO prequalification for use on the Cobas 6800 and 8800 systems.

WHO prequalification expands the availability of the test in countries that use the prequalification list to make purchasing and implementation decisions, which may enable more low- and middle-income countries to use the test in their national cervical cancer screening programs.

"These new prequalification designations for our Cobas HPV test will create strong momentum in the fight to eliminate cervical cancer," Roche Diagnostics CEO Matt Sause said in a statement. "Countries that use the WHO list to make decisions on how to implement national screening programs can now leverage self-collection to further increase access."

The test is used for primary screening and co-testing and detects 14 types of high-risk human papillomavirus genotypes, including HPV 16 and HPV 18. The firm's self-collection solution received US Food and Drug Administration approval for use with the Cobas HPV test last month.