Roche obtains prequalification from WHO for cobas HPV test

The cobas HPV test assesses the risk for cervical precancer and cancer.

RanjithKumar Dharma June 14 2023

Roche has received prequalification from the World Health Organization (WHO) for its cobas HPV test for use on the fully automated cobas 6800/8800 Systems.

The prequalification increases access to screening tools for cervical cancer in low and lower-middle-income countries.

Human Papillomavirus (HPV) screening will enable the detection of women who are at risk of cervical cancer development.

Part of the Roche Global Access Program, the cobas HPV test is intended for routine cervical cancer screening, including HPV primary screening, co-testing with cytology and triage of women with abnormal cytology.

The test will help evaluate the risk for cervical precancer and cancer. It can identify multiple high-risk HPV types.

The cobas 6800/8800 Systems can offer up to 96 results in around three hours. The cobas 6800 System can deliver 384 results and the cobas 8800 System can provide 1,056 results in an eight-hour shift.

Roche Diagnostics CEO Matt Sause said: “The elimination of cervical cancer is within reach. Roche is committed to working with governments, non-profit organisations 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.

“Today’s action, combined with our recently-launched HPV-self-sampling solution, further expands access to HPV screening in countries with limited healthcare resources.”

WHO intends to achieve three targets by 2030 to eliminate cervical cancer across the globe.

The goals include full vaccination of around 90% of girls with the HPV vaccine by 15 years of age, screening of 70% of women using a high-performance test by age 35 and again by age 45 and offering suitable treatment for 90% of identified cervical disease patients.

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