Roche cobas HPV test gets WHO prequalification

The cobas HPV test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 6

Published On 2023-06-13 06:45 GMT   |   Update On 2023-06-13 06:45 GMT

Basel: Roche has announced that the cobas HPV test for use on the cobas 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions.Screening for Human Papillomavirus (HPV) can...

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Basel: Roche has announced that the cobas HPV test for use on the cobas 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions.

Screening for Human Papillomavirus (HPV) can help identify women who are at risk of developing cervical cancer, so that the disease can be treated early, before invasive cancer has a chance to develop. In poorer countries, women are often diagnosed with cervical cancer at a more advanced stage, where the opportunity for a cure is low.

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

The WHO strategy for global elimination of cervical cancer lists the following three target goals to reach by 2030:

  • 90% of girls should be fully vaccinated with HPV vaccine by 15 years of age;
  • 70% of women should be screened using a high-performance test by age 35, and again by age 45;
  • 90% of those identified with cervical disease should receive appropriate treatment.

"The cobas HPV test is already part of the Roche Global Access Program, which aims to improve access to cost-effective resources, implement scale-up programs, and contribute to the elimination of diseases in the regions with the greatest need. WHO prequalification helps expand that access and provides healthcare professionals with greater confidence that their clinical decisions will be based on accurate, reliable results," the company stated.

The cobas HPV test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including HPV primary screening, co-testing (or adjunctive screen) with cytology, and for triage of women with abnormal cytology, to assess the risk for cervical precancer and cancer. The cobas® HPV test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

Read also: Roche unveils HPV self sampling solution against cervical cancer



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