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Roche launches human papillomavirus (HPV) self-sampling solution, expanding cervical cancer screening options - Jun 16 2022



Every year, over 604,000 women worldwide are diagnosed with cervical cancer and approximately 342,000 die from this preventable disease, caused by infection with Human Papillomavirus (HPV).

Nearly nine out of 10 women who die from cervical cancer live in low- and middle-income countries. For patients living in areas with limited healthcare resources, increasing access to screening and decreasing barriers to sample collection are keys to ultimately preventing this disease.

Roche’s HPV self sampling solution expands access to HPV screening options by enabling patients to privately collect their sample while at a healthcare facility.


Basel, 16 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of a human papillomavirus (HPV) self sampling solution in countries accepting the CE mark. This new solution enables a patient to privately collect her sample for HPV screening while at a healthcare facility, following instructions provided by a healthcare worker. The clinically-validated vaginal sample is analysed with the Roche cobas® HPV test on a Roche molecular instrument.

Screening for human papillomavirus (HPV) can help identify women who are at risk of developing cervical cancer, so that the disease can be found and treated early before it has a chance to develop. There are many drivers that contribute to women not participating in cervical cancer screening programs, including limited access to testing, past experiences, embarrassment and cultural influences. Roche’s self sampling solution helps reduce these barriers by offering women an alternative to more invasive clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions.

“The elimination of cervical cancer is within reach. Reducing barriers to HPV screening by enabling women to self-collect their own specimen for HPV testing is a critical tool in the fight against cervical cancer,” said Thomas Schinecker, CEO Roche Diagnostics.

In low- and middle-income countries, women are often diagnosed with cervical cancer at a more advanced stage, where the opportunity for cure is low. By broadening access through removing barriers and enabling screening in additional healthcare environments, Roche highlights its commitment to achieving the World Health Organisation’s global strategy to eliminate cervical cancer and reduce the overall mortality rate.

About the cobas HPV test

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. Test performance for this new sampling method demonstrates that self-collected vaginal specimens tested using a molecular technology are fully adequate, and provide results that are comparable to clinician-collected cervical samples.

Cervical cancer screening using the cobas HPV test is clinically validated in large, FDA registrational trials for use on cobas systems, and the assay individually identifies the presence of the DNA of HPV genotypes 16 and 18 – the two genotypes responsible for about 70 percent of all cervical cancers4 – and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. More information about the cobas HPV tests is available at diagnostics.roche.com/cervicalcancer or cervicalcancer-screening.com.

The fully automated cobas 6800/8800 Systems offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. Learn more now: http://diagnostics.roche.com.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan

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