Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
- Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV - from appropriate counseling on disease differences to targeted therapy
- Supports rapid molecular detection of acute HIV infection, which is critical in curbing further disease transmission
- Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into one single test
Basel, 1 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options.
“Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS,” said Thomas Schinecker, CEO Roche Diagnostics. “Being able to reliably determine a person’s HIV status and accurately diagnose which HIV type they may have is crucial for patients and healthcare providers in preventing further community transmission and selecting an individual’s best treatment options.”
Studies show that 50% of new HIV infections may be transmitted during the acute period, between three days and three weeks from the time of infection1. Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate. The higher sensitivity of PCR technology, which is used with the cobas HIV-1/HIV-2 Qualitative Test, can reduce this time-to-detection period by one week or more. This significant reduction in time to detection is critical to improve personalised healthcare while curbing further disease transmission.
About the cobas HIV-1/HIV-2 Qualitative Test
cobas HIV-1/HIV-2 Qualitative for use on the cobas 6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.
The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. cobas HIV-1/HIV-2 Qualitative may also be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women.
About HIV-1 and HIV-2 in the U.S.
The U.S. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 million people were living with HIV in the United States. Among them, more than 160,000 people did not know their HIV status, and only 53 percent were virally suppressed having low amounts of virus circulating in their blood. During this same year, 37,968 people became newly infected with HIV2.
Human immunodeficiency virus (HIV) is categorized into two types, HIV-1 and HIV-2. Worldwide, most HIV infections are HIV-1, whereas HIV-2 largely has been confined to persons in or from West Africa. However, HIV-2 has been steadily increasing in the U.S. due to immigration3. HIV-1 and HIV-2 have the same routes of transmission, and both can cause acquired immunodeficiency syndrome (AIDS); however, it is important to differentiate HIV-2 infections from HIV-1 infections because they require different clinical management4.
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. 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 now: www.cobas68008800.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 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 eleventh 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 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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.
 Branson BM, Mermin J. Establishing the diagnosis of HIV infection: new tests and a new algorithm for the United States. J Clin Virol. 2011;52 Suppl 1:S3-S4. doi:10.1016/j.jcv.2011.09.024
 Statistics Overview. Centers for Disease Control and Prevention website. Reviewed June 8, 2020. Accessed July, 24 2020. https://www.cdc.gov/hiv/statistics/overview/index.html.
 Campbell-Yesufu OT, Gandhi RT. Update on human immunodeficiency virus (HIV)-2 infection. Clin Infect Dis. 2011;52(6):780-787. doi:10.1093/cid/ciq248
 Ekouevi DK, Tchounga BK, Coffie PA, et al. Antiretroviral therapy response among HIV-2 infected patients: a systematic review. BMC Infect Dis. 2014;14:461. Published 2014 Aug 26. doi:10.1186/1471-2334-14-461
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
| Daniel Grotzky |
Phone: +41 61 688 31 10
| Karsten Kleine|
Phone: +41 61 682 28 31
| Nina Mählitz|
Phone: +41 79 327 54 74
| Nathalie Meetz|
Phone: +41 61 687 43 05
| Barbara von Schnurbein|
Phone: +41 61 687 89 67
|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
| Dr. Lisa Tuomi|
Phone: +1 650 467 8737
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
Millicom CEO Mauricio Ramos to be keynote speaker at GSMA Thrive Latin America30.11.2020 21:00:00 CET | Press release
Millicom CEO Mauricio Ramos to be keynote speaker at GSMA Thrive Latin America Luxembourg, November 30, 2020 – Millicom, a leading provider of cable and mobile services operating as TIGO in Latin America, is pleased to announce that CEO Mauricio Ramos will present at GSMA Thrive Latin America as an invited keynote speaker on December 2. As a global leader in the telecommunications sector, Mr. Ramos will discuss the importance of accelerating connectivity to reinvigorate economies in Latin America and its positive effect on communities. GSMA Thrive Latin America brings together Latin America’s policymakers, digital leaders, and innovators to uncover the opportunities of emerging next-generation technologies and inspire thought leadership to solve the challenges of realizing a truly connected world. Mr. Ramos’s keynote presentation at GSMA Thrive Latin America is scheduled for Wednesday, December 2 at 10:00 a.m. ET. Free registration and the keynote can be accessed here [LINK]. -END- For
GOGL – Declaration of options30.11.2020 19:40:09 CET | Press release
The Board of Golden Ocean Group Limited (NASDAQ and OSE: GOGL) (“Golden Ocean” or the “Company”) announced an option holder has exercised options to acquire 50,000 shares in the Company in accordance with the terms previously disclosed. The option exercise will be settled in full with treasury shares held by the Company. Following the delivery of the shares, Golden Ocean will hold a total of 945,000 treasury shares. November 30, 2020 Hamilton, Bermuda The Board of Directors Golden Ocean Group Limited This information is subject to the disclosure requirements of section 5-12 of the Norwegian Securities Trading Act.
Saudi Arabian Oil Company and Shell & AMG Recycling B.V. Sign Agreement to Explore the Feasibility of Building a Recycling “Supercenter” in The Kingdom of Saudi Arabia30.11.2020 18:00:00 CET | Press release
Amsterdam, 30 November 2020 (Regulated Information) --- The Saudi Arabian Oil Company (Saudi Aramco), Shell & AMG Recycling B.V. signed a memorandum of understanding (MOU) to evaluate the feasibility of creating a venture in support of Saudi Arabia’s (“The Kingdom”) vision to maximize value from its vast natural resources. The Kingdom is becoming a globally important region for the supply and demand of vanadium, and desires to enable the development of a world class vanadium recycling industry. In support of this initiative, Shell & AMG Recycling B.V., along with Shell Catalysts & Technologies, will explore the feasibility of building a catalyst manufacturing and recycling “supercenter” in The Kingdom. This “supercenter” will enable Saudi Aramco to refine its crudes in an environmentally sustainable manner through the manufacturing of fresh residue upgrading catalysts required to convert heavy oil fractions into valuable products and recycling the resulting spent catalysts and gasifica
Orange Belgium expands its Executive Committee with Isabelle Vanden Eede as Chief Brand, Communication & CSR Officer and Bart Staelens as Chief Transformation & Customer Experience Officer30.11.2020 18:00:00 CET | Press release
Press release Brussels, November 30, 2020 Orange Belgium expands its Executive Committee with Isabelle Vanden Eede as Chief Brand, Communication & CSR Officer and Bart Staelens as Chief Transformation & Customer Experience Officer Orange Belgium's Board of Directors validated the nomination of Isabelle Vanden Eede as Chief Brand, Communication & CSR Officer and Bart Staelens as Chief Transformation & Customer Experience Officer, both starting December 1, 2020. Isabelle Vanden Eede, 45 years old, has 23 years of branding and communication experience. She started her career at Ogilvy & Mather Advertising, managing the agencies’ telecom clients. She continued to refine her communication skills at VVL BBDO and Famous agencies, before joining Mobistar in 2010 to be responsible for the residential communication. For the past 10 years Isabelle evolved to Brand & Communication Director, responsible for the rebranding from Mobistar to Orange Belgium. Known for her strategic skills and broad exp
PRESS RELEASE: BIGBEN: Half year results 2020/2130.11.2020 18:00:00 CET | Press release
Bigben Press release Lesquin, 30 November 2020 18:00 Half year results 2020/21: ·Current Operating Income: 16.9 M€ (+26.4%) i.e. 12.5% of sales ·Net result: 9.7 M€ (+16.7%) Rise of target for FY 2020/21 Current Operating Income rate: > 12% BIGBEN INTERACTIVE (ISIN FR0000074072) today releases its consolidated results for the first half of fiscal year 2020/21 (from April 1 to September 30) as approved by its Board of directors on 30 November 2020. Consolidated in M€ - IFRS09/202009/2019 ChangeSales135.8127.0+6.9%Gross margin (1) In % of Sales EBITDA (2) In % of Sales 57.3 42.3% 33.4 24.6% 54.9 43.2% 27.7 21.8%+4.4% +20.5% Current operating income In % of Sales Non recurrent items16.9 12.5% (2.3)13.4 10.5% (1.5) +26.4% Operating result In % of Sales14.7 10.8%11.9 9.4%+23.2%Financial result Including currency gain (loss)(1.2) (0.7)(1.0) (0.3) Earnings before tax In % of Sales13.5 9.9%10.9 8.6%+23.0%Tax(3.7)(2.6)Net result for the period In % of Sales9.7 7.2%8.3 6.6% +16.7% Of which Minori
PRESS RELEASE: NACON: Strong increase in profitability in 1st half30.11.2020 18:00:00 CET | Press release
Nacon Press release Lesquin, 30 November 2020, 18:00 hrs Strong increase in profitability in 1st half: ·Current Operating Profit : 15.7 M€ (+47.3%) i.e. 18.2% of sales ·Net Result: 9.6 M€ (+46.7%) Outlook: New Upward revision of FY 2020/21 sales: 160-170 M€ NACON (ISIN FR0013482791) today releases its audited consolidated results for the first half of fiscal year 2020/21 (from April 1 to September 30) as approved by its Board of directors on 30 November 2020. Consolidated in M€ - IFRS09/2020 09/2019 (3) ChangeSales86.663.7+35.9%Gross margin (1) In % of Sales EBITDA (2) In % of Sales 45.3 52.3% 30.4 35.1% 39.2 61.5% 23.5 37.0%+15.5% +29.2%Current operating income EBITA In % of Sales Non recurrent items (including Bonus Shares)15.7 18.2% (1.8)10.7 16.8% (1.0) +47.3% Operating result In % of Sales13.9 16.1%9.7 15.2%+43.3%Financial result Including currency gain (loss)(0.8)(0.5) Earnings before tax In % of Sales13.1 15.2%9.3 14.5%+41.8%Tax(3.6)(2.7)Net result for the period In % of Sales9.