Roche (RHHBY) said that the World Health Organization or WHO has awarded the cobas HPV test prequalification designations for use on the cobas 5800 system and for self-collected samples on the cobas 5800, 6800 and 8800 systems.
The new prequalification designations come just one month after the U.S. Food and Drug Administration approved Roche's HPV self-collection solution and less than a year after the WHO awarded prequalification to the cobas HPV test on the cobas 6800/8800 systems.
The company noted that the WHO prequalification enables low- and middle-income countries (LMICs) to use Roche HPV screening solutions, including self-collection, in their national cervical cancer elimination programs, which will greatly increase access.
Every year, over 600,000 women worldwide are diagnosed with cervical cancer and over 340,000 die from this preventable disease, caused by HPV infection. Nine out of 10 women who die from cervical cancer live in LMICs.
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