WHO guidelines now include Roche’s diagnostic tests in expanded effort to eliminate tuberculosis by providing patients greater access to timely diagnosis
- Tuberculosis is a disease of poverty, and economic distress with 1.4 million deaths annually1 and the growing challenge of drug resistance is adding to the global health crisis
- WHO guidelines support the expansion of tuberculosis diagnostics in resource-limited countries, enabling patients to receive timely diagnosis leading to proper treatment, which benefits their recovery and slows the transmission of disease
- Roche’s Global Access Program aids clinicians in improving disease and patient management through increased access to innovative diagnostic solutions, allowing more patients to get test results promptly
Basel, 09 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas® MTB and cobas® MTB-RIF/INH tests for use on the cobas® 6800/8800 Systems are included as part of the updated World Health Organization (WHO) policy guidelines on nucleic acid amplification tests (NAATs) to detect tuberculosis (TB) and drug-resistant TB. The new guidance expands the number of rapid molecular tests available to national TB programmes in high-burden countries, enabling multi-partner diagnostic approaches that can benefit patients and communities.
The WHO estimates that about 1.7 billion people are living with tuberculosis globally, with an estimated 10 million new active tuberculosis cases and 1.4 million deaths annually. Approximately 29% of new infections were undiagnosed and untreated, potentially contributing to further transmission. When drug-resistant TB (RR/MDR-TB) is present, the challenge is greater, with only 44% properly diagnosed.1 Although TB can be cured once it is diagnosed, people affected are often faced by vulnerability, marginalization, stigma and discrimination.
To increase early detection, diagnosis, and treatment of TB among vulnerable populations, the updated WHO guidelines aim to help countries identify populations at highest risk of infection and the locations most affected. This includes 30 low- and middle-income countries (LMICs), which bear the majority of the TB burden.1 These countries rely on the WHO to evaluate test performance and provide centralised testing guidance and diagnostic guidelines prior to the use of any TB test. The new policy guidance enables LMICs to use donor funds for implementation and purchase of TB tests, increasing diagnostic options for people living with TB and drug-resistant TB.
“Roche’s diagnostic solutions detect both TB and drug-resistant TB, enabling patients to be diagnosed earlier and treated with the appropriate regimen to stop the spread of the disease,” said Thomas Schinecker, CEO Roche Diagnostics. “Roche plays a significant role in the fight against TB through our Global Access Program, which focuses on sustainable solutions that can help diagnose infections and save lives.”
WHO guidelines are an important step toward ending the global TB epidemic by increasing patient access to high-quality diagnostics. The organisation’s multi-faceted End TB Strategy aims in part for a 90 percent overall reduction in TB incidence and a 95 percent reduction in TB deaths by 2035. High-volume, multi-disease testing systems and innovative diagnostic tests can accelerate eradication efforts and further improve health outcomes for people living with TB.
About the Global Access Program
In 2014, Roche announced the Global Access Program for increased access to HIV diagnostics. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including UNAIDS, Clinton Health Access Initiative (CHAI), Unitaid, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Global Fund and Center for Disease Control and Prevention (CDC) to establish programmes that would go beyond providing diagnostic tests.
Since its inception, the program has expanded substantially in menu and geographic footprint to provide increased access to diagnostics at affordable pricing for qualifying organisations in eligible countries with the highest disease burden. The Global Access Program includes diagnostic solutions for HIV, Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV) and human papillomavirus (HPV) to help towards implementation of elimination programmes in efforts to eradicate disease and in line with the 2030 elimination goals.
About the cobas MTB and cobas MTB-RIF/INH tests
The cobas MTB and cobas MTB-RIF/INH molecular tests provide clinicians flexibility to detect a combination of tuberculosis and drug-resistant tuberculosis infections from a single patient sample. When a patient presents with symptoms of tuberculosis, the highly sensitive cobas MTB test is performed. If positive, the patient should be evaluated for drug resistance using cobas MTB-RIF/INH test. Roche’s mycobacteria tests are for use on the cobas 6800/8800 Systems.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The cobas 6800/8800 Systems are part of the Molecular Work Area—a fully integrated laboratory workflow strategy that empowers labs to further elevate their levels of efficiency, flexibility and scalability. With proven performance, absolute automation, and unmatched flexibility delivering unparalleled throughput 24/7, cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever. Learn more: www.molecularworkarea.com.
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, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.
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. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.
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. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
 Global tuberculosis report 2020. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: email@example.com
| Dr. Nicolas Dunant|
Phone: +41 61 687 05 17
| Patrick Barth|
Phone: +41 61 688 44 86
| Dr. Barbara von Schnurbein|
Phone: +41 61 687 89 67
| Karsten Kleine|
Phone: +41 61 682 28 31
| Nina Mählitz|
Phone: +41 79 327 54 74
| Nathalie Meetz|
Phone: +41 61 687 43 05
|Roche Investor Relations|
| Dr. Karl Mahler|
Phone: +41 61 68-78503
| Jon Kaspar Bayard|
Phone: +41 61 68-83894
| Dr. Sabine Borngräber|
Phone: +41 61 68-88027
| Dr. Bruno Eschli|
Phone: +41 61 68-75284
| Dr. Birgit Masjost|
Phone: +41 61 68-84814
| Dr. Gerard Tobin|
Phone: +41 61 68-72942
|Investor Relations North America|
| Loren Kalm|
Phone: +1 650 225 3217
AttachmentTo view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Idorsia announces financial results for the first half 2021 – Building momentum towards becoming a fully-fledged biopharmaceutical company27.7.2021 07:01:34 CEST | Press release
Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – July 27, 2021 Idorsia Ltd (SIX: IDIA) today announced its financial results for the first half of 2021. Business highlights Daridorexant for the treatment of insomnia under review with US FDA, EMA, and SwissmedicNine scientific presentations for daridorexant shared at SLEEP 2021Ponesimod to treat relapsing forms of multiple sclerosis was approved by the US FDA and the European Commission, Idorsia receives first income from the revenue-sharing agreement in respect to ponesimodClazosentan NDA for the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) submitted to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in March 2021“SOS-AMI” Phase 3 registration study with selatogrel in suspected acute myocardial infarction (AMI) initiated in June 2021Phase 2 study with ACT-539313 for binge eating disorder initiated in March 2021Results for MODIFY Phase 3 study with lucerastat for Fabry
Hyloris to Report 2021 Half-Year Results on 4 August 202127.7.2021 07:00:00 CEST | Press release
Liège, Belgium – 27 July 2021 –Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that it will host a conference call and audio webcast on Wednesday, 4 August 2021 at 3:00 pm CEST (9:00 am EST) to present its half-year 2021 financial results and to provide a business update. The presentation will be followed by a live Q&A session. The webcast may be accessed on the Events page of the company’s website or by clicking here. To participate in the Q&A session of the conference call, please dial one of the following numbers, ten minutes prior to the start of the live webcast: Belgium +32 2 79 338 47 France +33 1 70 700 781 Netherlands + 31 20 795 6614 United Kingdom +44 2071 928 338 United States +1 646 741 3167 Confirmation code 2687826 Following the call, a replay of the webcast will be available on the events page of the Hyloris website. About Hyloris Phar
Organon and ObsEva Enter Global License Agreement to Develop and Commercialize Ebopiprant (OBE022), an Investigational Agent Being Evaluated as a First-in-Class Treatment for Preterm Labor27.7.2021 07:00:00 CEST | Press release
Every year, an estimated 15 million babies are born preterm (before 37 completed weeks of gestation)i; agent is being studied in an area of significant unmet need Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange Jersey City, N.J., Geneva, Switzerland, July 27, 2021 - Organon (NYSE: OGN), a global women’s health company and ObsEva (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company dedicated to improving women’s reproductive health, today announced that the companies have entered into an agreement whereby Organon will license the global development, manufacturing and commercial rights to ebopiprant (OBE022). Ebopiprant is an investigational, orally active, selective prostaglandin F2α (PGF2α) receptor antagonist being evaluated as a potential treatment for preterm labor by reducing inflammation and uterine contractions. If approved, it has potential to be a first-in-class innovation for this common and serious condition with no approved therapies for acute treatme
Wereldhave N.V.: Results H1 202127.7.2021 07:00:00 CEST | Press release
Key items Major step in phasing out France: sold four out of six French assets for € 305mBenelux disposal program finalized, Koningshoek sold above book value LTV down to 46% - pro-forma for four asset French disposal 42%Dutch valuations stabilizing for the first time in nine valuation roundsAs a result of disposals, outlook 2021 direct result now at € 1.75 - 1.85 per shareOutlook direct result 2022 reiterated at € 1.40 - € 1.50 per share; to be followed by 4 - 6% annual growthDividend guidance 2021 minimum € 1.00 per share Attachment Wereldhave pr 2021-H1 - vFINAL
Leasinvest Real Estate SA: Publication of a transparency notification26.7.2021 18:00:00 CEST | Press release
PUBLICATION OF A TRANSPARENCY NOTIFICATION IN ACCORDANCE WITH THE LAW OF 02/05/2007 ON THE DISCLOSURE OF IMPORTANT PARTICIPATIONS A notification of 26 July 2021 issued by AG Insurance, shows that both a passive threshold overrun and a drop below the minimum threshold took place, following the introduction of the double voting rights and a capital increase by contribution in kind from a/o Extensa Group, as approved at the extraordinary general meeting of Leasinvest Real Estate on 19 July 2021. The total number of voting rights of AG Insurance in Leasinvest Real Estate has therefore decreased to 2.58% of the voting rights in Leasinvest Real Estate NV (hereinafter the "Company”). The notification comprises the following information: REASON FOR THE NOTIFICATION: Passive threshold overrun - Drop below the minimum threshold NOTIFICATION: by the parent company or controlling person. PERSON(S) SUBJECT TO THE NOTIFICATION REQUIREMENT Name and legal formAddress Ageas SA/NV Rue du Marquis 1, 1000
PRESS RELEASE: BIGBEN: Q1 2021/22 Sales26.7.2021 17:50:00 CEST | Press release
Bigben Press release Lesquin, 26 July 2021 18:00 hrs Q1 2021/22 Sales: 56.7 M€ (+2.8%) High sales historyforNacon Gaming Favourable base effect for Audio-Telco Confirmation of FY 2021/22 and FY 2022/23 targets IFRS – M€ Sales 2021/2022 2020/2021 Change 1st Quarter Nacon Gaming Bigben Audio-Telco 56.7 33.7 23.0 55.2 38.0 17.2 +2.8% -11.3% +33.9% Non audited data In Q1 FY 2021/22 (April 1 to June 30, 2021), Bigben posted sales of €56.7 million, an increase of 2.8%, driven by Audio-Telco, which benefited from a favourable comparison basis, unlike the Nacon Gaming business unit, demonstrating the benefit from being present across several markets. NACON GAMING In Q1 2021/22, Nacon achieved sales of 33.7 M€, down 11.3% on Q1 2020/2021. Despite an unfavourable comparison basis, the back catalogue showed a positive momentum. Games: The segment posted sales of 12.2 M€, down 16.0% compared with Q1 2020/21, whose back catalogue sales had been boosted by 340% by lockdown. The back catalogue demons
PRESS RELEASE: NACON: Q1 2021/22 Sales26.7.2021 17:45:00 CEST | Press release
Press release Lesquin, 26 July 2021 18 :00hrs Q1 2021/22 Sales : 33.7 M€(-11.3%) High comparison basisBack catalogue résilience Confirmation ofFY 2021/22 and FY 2022/23targets IFRS – M€ Sales Non audited data 2021/2022 2020/2021 Change 1st Quarter Games Accessories Others(1) 33.7 12.2 20.6 0.9 38.0 14.5 22.5 0.9 - 11.3% -16.0% -8.8% + 0.5% (1)Mobile and Audio sales. In Q1 2021/22 (from 1 April to 30 June 2021), Nacon achieved sales of 33.7 M€, down 11.3% compared to Q1 2020/2021. Despite an unfavourable comparison basis, the back catalogue showed a positive momentum. GAMES The video games business posted sales of 12.2 M€, down 16.0% compared with Q1 2020/21, when back catalogue sales were boosted 340% by lockdown. However the good performance of the back catalogue demonstrated its resilience with sales of 9.2 M€ against 10.8 M€ in Q1 2020/21 during the first lockdown, to be compared with 2.4 M€ in Q1 2019/20. The Roguebook (81% positive reviews on Steam) and Pro Cycling Management / To