Roche Canada announces the first human papillomavirus (HPV) self-collection solution to help eliminate cervical cancer

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  • Human papillomavirus (HPV) is the most widely spread sexually transmitted infection. There are more than 150 different genotypes of HPV, and some are considered high-risk for cervical cancer.1

  • Cervical cancer incidence increased by an average of 3.7% per year from 2015 to 2019, marking the first significant increase in incidence since 1984. It is now the fastest-increasing cancer among women.2

  • In Canada, 16.3 million women aged 15 years and older are at risk of developing cervical cancer, making it the 4th most frequent cancer among women between 15 and 44 years of age across the country.3

  • Current estimates indicate that 1,600 women will be diagnosed with cervical cancer in Canada in 2024, and 400 will die from the disease.4

  • Roche’s human papillomavirus (HPV) self-collection solution, approved by Health Canada in August 2023, will improve access to cervical screening by providing individuals with a cervix an accurate and reliable option to collect their own sample privately.

Laval, Quebec, June 3, 2024 - Roche Diagnostics, a division of Hoffmann-La Roche Limited, is proud to be the first to obtain Health Canada approval for the claim “HPV Self-Collection” for Roche’s cobas® HPV test. This exciting and innovative option can help reduce screening barriers by offering a less invasive clinical collection procedure, while also providing accurate and reliable results to help clinicians make better patient care decisions.

“Self-collection offers an effective and flexible option to help individuals overcome barriers to cervical cancer screening,” said Michele D’Elia, Executive Director of Medical, Access and Policy at Roche Diagnostics. “We have the opportunity to decrease cervical cancer incidence and work towards meeting the World Health Organization (WHO) and Canadian Partnership Against Cancer (CPAC) goals for cervical cancer elimination. This can only be achieved by replacing the Pap test with HPV testing as part of primary screening programs, and including the option of self-collection to reduce the barriers to screening for all people with a cervix.”

Why cervical screening can save lives? 

Screening for HPV can help identify those at risk of developing cervical cancer so that the disease can be found and treated early before it has a chance to become more serious. Yet there remain many barriers to cervical cancer screening programs, including limited access to testing, difficult past experiences and distrust, and cultural influences. In addition, while Pap tests have revolutionized the ability to detect early cervical cancer in Canada over the last 70 years and have greatly reduced the number of women who die from the disease, it remains an invasive procedure with a high potential for “false negative” results.5

HPV Self-Collection: The Latest Alternative to Help prevent Cervical Cancer

HPV Self-collection is considered the next technological advancement needed to flatten the curve toward the elimination of cervical cancer. The transition from Pap testing to HPV self-collection is also supported by the Action Plan for the Elimination of Cervical Cancer in Canada, 2020–2030, Canada’s response to the World Health Organization’s call to eliminate cervical cancer worldwide within the century.6

“Roche is committed to women’s health, and Canada’s initiative to eliminate cervical cancer is one we take to heart. We, as well as many others, are actively working to help fulfill this promise. Our stance is clear: eliminating cervical cancer requires both HPV vaccination and screening,” concluded Michele D’Elia.

About the cobas® HPV test

Roche’s cobas® HPV test is designed to identify women at risk for cervical cancer by detecting the presence of high-risk HPV DNA in cervical cells. The goal of cervical cancer screening using the cobas® HPV Self-Collection test is to find and treat precancerous lesions early to help stop the progression of the disease. Thanks to this claim approved by Health Canada, individuals can privately collect a vaginal sample for HPV screening following the instructions of a healthcare worker.

 About the Roche Cervical Cancer Portfolio

Roche’s cervical cancer portfolio includes the cobas® HPV Test which detects 14 high-risk HPV genotypes that can put patients at an increased risk of developing cervical cancer. It includes individual results for HPV 16 and HPV 18,  and a pooled result for 12 other high-risk HPV genotypes. 

The HPV self-collection solution is approved for use with Roche's cobas® HPV test. The cobas® HPV test runs on the cobas® 4800 and the fully automated cobas® 5800/6800/8800 Systems, which offers the fastest time to results, providing up to 24 results in two hours forty-five min for the cobas 5800 and 96 results in about three hours, for a total of  384 results for the cobas® 6800 System and 1,056 results for the cobas® 8800 System in less than an eight-hour shift. 

Learn more: 

Roche Canada website 

HPV Prevention Blog





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 5 Andrae B et al. J Natl Cancer Inst. 2008;100(9):622–629.

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