Roche expands access to cervical cancer screening tools with two
new WHO prequalification designations, including HPV
self-collection
- The World Health
Organization (WHO) has awarded Roche's human papillomavirus (HPV)
test prequalification designations for use on the cobas 5800 System
and for self-collected samples on the cobas 5800, 6800 and 8800
Systems.
- These designations build
upon last June's WHO prequalification that included the cobas HPV
test for use on the cobas 6800 and 8800 Systems.
- 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.1
Basel, 27 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the World Health Organization (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. These 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.
“No woman in the world should die from this preventable disease.
These new prequalification designations for our cobas HPV test will
create strong momentum in the fight to eliminate cervical cancer,”
said Matt Sause, CEO of Roche Diagnostics. “Countries that use the
WHO list to make decisions on how to implement national screening
programs can now leverage self-collection to further increase
access.”
The WHO is focused on the elimination of cervical cancer
globally with a strategy of three key goals.2 It seeks
to ensure that by 2030, 70% of women are screened using a
high-performance test by age 35, and again by age 45. Screening for
HPV can help identify women who are at risk of developing cervical
cancer, so that the disease can be treated early, before cancer has
a chance to develop. In poorer countries, women are often diagnosed
with cervical cancer at a more advanced stage, where the chance for
a cure is low. The WHO also seeks to ensure that 90% of girls are
fully vaccinated against HPV by 15 years of age, and that 90% of
those identified with cervical disease receive appropriate
treatment.
The cobas HPV test prequalification designations from the WHO
help expand access and provide healthcare professionals with
greater certainty that their clinical decisions will be based on
accurate, reliable results.
Fighting cervical cancer
Roche partners with health systems and governments in more than 55
countries to support their cervical cancer screening programs with
the cobas HPV test. As a result of these collaborations, more women
have been accessing HPV molecular testing. For example, after just
one year of Roche and the Perúvian Ministry of Health working
together with other government organisations and patient advocates,
more than 300,000 unscreened or underscreened women, some in remote
areas of the Amazon rainforest, have been tested for HPV using
Roche’s self-collection solution as the primary strategy to expand
access.
The cobas HPV test is also 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.
About the Global Access Program
In 2014, Roche first launched its Global Access Program to support
the UNAIDS 2020 targets to address the HIV/AIDS epidemic. Since
then, the program has expanded to include solutions for other
high-burden diseases such as Tuberculosis, Hepatitis B and C, and
cervical cancer. Most recently, in response to the COVID-19
pandemic, the SARS-CoV-2 test was included into the program.
The continual expansion of test offerings highlights Roche's
commitment to eliminating cervical cancer and other high-burden
infectious diseases for patients living in resource-constrained
settings with limited access.
Any laboratory that implements a Roche instrument system gains
the ability to scale up testing across multiple disease areas, thus
improving cost and resource efficiency. An integrated approach
supports national programs focused on increasing access to
diagnostic testing, to help manage or reduce the impact of
preventable disease for patients.
About the Roche Cervical Cancer Portfolio
HPV is the known cause of more than 95% of all cervical
cancers.2 Roche’s cervical cancer portfolio includes the
cobas HPV test, used for primary screening and co-testing. While
the Pap smear can potentially detect abnormalities in the cervix,
cobas HPV detects 14 types of high-risk HPV genotypes that put
patients at higher risk of developing cervical cancer. It includes
results for HPV 16, HPV 18 and 12 other high-risk pooled
genotypes.3
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 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. The
portfolio also includes CINtec PLUS Cytology, the only FDA-approved
dual-stain product and CINtec® Histology, the only FDA-cleared p16
biomarker technology that can help pathologists confirm the
presence of pre-cancerous cervical lesions.
The IMPACT trial design, used to validate the clinical benefits
of the Roche cervical cancer portfolio, had representation from
diverse patient segments, including 21 percent Black, 24 percent
Hispanic-Latino and 0.3 percent American Indian or Alaskan Native
participants.4 This diversity was critical to accurately
assess the performance of dual stain in patient populations with
higher incident rates of HPV. Learn more now:
http://diagnostics.roche.com
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] World Health Organization. Cervix uteri. Fact sheet [Internet;
updated 2021 January; cited 2023 Jan 3] Available from:
https://gco.iarc.fr/today/data/factsheets/cancers/23-Cervix-uteri-fact-sheet.pdf
[2] World Health Organization. Global strategy to accelerate the
elimination of cervical cancer as a public health problem. Article
[Internet; updated 2020 November 17; cited 2023 Jan 3] Available
from: https://www.who.int/publications/i/item/9789240014107
[3] National Cancer Institute. HPV and Cancer. Fact sheet
[Internet; cited 2024 June 4]
https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer#:~:text=Sexually%20transmitted%20HPV%20types%20fall,for%20most%20HPV%2Drelated%20cancers
[4] Safaeian M, Wright TC Jr, Stoler MH, Ranger-Moore J, Rehm S,
Aslam S, Fang Q, Volkir P, Ridder R. The IMproving Primary
Screening And Colposcopy Triage trial: human papillomavirus,
cervical cytology, and histopathologic results from the baseline
and 1-year follow-up phase. Am J Obstet Gynecol. 2021
Sep;225(3):278.e1-278.e16. doi: 10.1016/j.ajog.2021.03.047. Epub
2021 Apr 20. PMID: 33852886
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
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