Roche introduces the cobas 5800, a new molecular diagnostic system to expand access to PCR testing in the U.S.
Roche has announced the upcoming U.S. launch of the cobas® 5800 System, a compact, fully automated molecular testing solution designed to enhance the diagnosis of infectious diseases. The cobas 5800 is FDA-approved for the cobas HIV-1 assay and aims to streamline workflows in labs of all sizes, delivering up to 144 results in eight hours. This new system addresses challenges faced by laboratories, including staffing shortages and increasing testing requirements. The cobas 5800 will be showcased at the Association for Molecular Pathology Annual Meeting in Phoenix, Arizona.
- FDA premarket approval for the cobas HIV-1 assay enhances the product's market positioning.
- cobas 5800 System improves workflow efficiencies and enables labs to test multiple assays simultaneously.
- Expected to address laboratory challenges due to staffing shortages and evolving patient needs.
- None.
- cobas 5800 is a new compact addition to the Roche molecular diagnostics portfolio that provides a scalable, high performance testing solution for labs of all sizes.
- Infectious diseases, such as HIV, Hepatitis, transplant associated viral illnesses, and respiratory and STIs, represent an ever-growing medical need for millions of patients worldwide.
- Access to accurate and reliable diagnostic tests help clinicians improve patient care, limit healthcare spending and contribute to protecting public health.
INDIANAPOLIS, Nov. 1, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced plans for the U.S. launch of the cobas® 5800 System, a compact, fully-automated molecular laboratory instrument that offers a flexible, PCR testing solution that aids clinicians in diagnosis of infectious diseases. Built upon the proven technology platform of the cobas® 6800/8800 Systems, the cobas 5800 is designed to provide optimized workflow efficiencies, simplicity and timely results that can benefit labs of all sizes.
The company has received U.S. Food and Drug Administration premarket approval for the cobas HIV-1 assay, the first in the cobas x800 family of assays available for use on the cobas 5800 System, a Class 2 exempt medical device. The new system and assay will become commercially available in Q4, 2022, and will be showcased at the Association for Molecular Pathology 2022 Annual Meeting and Expo, November 1-5 in Phoenix, Arizona (Booth #1101).
Laboratories are facing unprecedented challenges from staffing shortages, to evolving patient testing needs for COVID-19, and are looking for innovative solutions that allow them to do more with limited resources and space. The cobas 5800 will bring a shared clinical menu of molecular diagnostics testing capabilities to smaller and mid-size labs, and flexibility to larger labs that may use cobas 6800/8800 or systems from other vendors.
"We are pleased to provide the cobas 5800 to expand our molecular portfolio with a flexible solution to meet the needs of labs and health systems serving communities throughout the U.S.," said Matt Sause, president and CEO of Roche Diagnostics North America. "The new system furthers our commitment to improve patient care by broadening access to high quality test results so clinicians can make the best treatment decisions for their patients."
The cobas 5800 System is a real-time molecular testing solution that provides excellent performance and value-added utility from a compact footprint. The cobas 5800 System delivers automation, consolidation, integration and standardization – making it a scalable, cost-efficient solution for smaller labs seeking big lab performance, or for larger labs seeking small lab agility.
The system is built to offer a fully automated workflow that encompasses sample transfer and preparation, amplification and detection, result calculation and delivery to the laboratory information system. Designed as one integrated instrument, the cobas 5800 System enables a walkaway time of up to eight hours*, resulting in less hands-on time, which can lead to improved productivity, reduced possibility for errors and more predictable turnaround times.
The cobas 5800 System offers an expanded on board capacity allowing labs to test multiple assays simultaneously and delivers up to 144 results in an eight-hour shift. This streamlined molecular testing system will allow most labs to consolidate greater than 90 percent** of their routine molecular tests onto a single platform. For more information please visit diagnostics.roche.com.
Founded in Basel, Switzerland, in1896 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 personalized 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 recognizing our endeavor 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 thirteenth 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.
*Walkaway time is dependent on the number of tests performed and number of runs initiated (under continuous testing conditions >96 tests per shift, walkaway time may be between 4 - 8 hours).
**Dependent on molecular assays being run.
Roche Diagnostics U.S. Media Relations
us.mediarelations@roche.com
Krystina Monaco
1 (513) 850-7521 / krystina.monaco@roche.com
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