GlobeNewswire by notified

Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection

Share
  • 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

Hans Trees, PhD
Phone: +41 79 407 72 58
Sileia Urech
Phone: +41 79 935 81 48

Nathalie Altermatt
Phone: +41 79 771 05 25

Simon Goldsborough
Phone: +44 797 32 72 915

Karsten Kleine
Phone: +41 79 461 86 83

Nina Mählitz
Phone: +41 79 327 54 74
Kirti Pandey
Phone: +49 172 6367262

Yvette Petillon
Phone: +41 79 961 92 50
Dr. Rebekka Schnell
Phone: +41 79 205 27 03

Attachment

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release

Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a

DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release

Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68

Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release

Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.

Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release

AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us

Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release

VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin

HiddenA line styled icon from Orion Icon Library.Eye