Roche receives FDA concurrence for COVID- 19 PCR test for use on cobas6800/8800 Systems
The cobas SARS- CoV- 2 Qualitative test is one of the first COVID- 19 PCR tests performed on an automated, high outturn platform to admit FDA 510( k) concurrence.
This FDA concurrence will insure that the healthcare community has access to timely, dependable and accurate COVID- 19 PCR testing beyond the EUA period.
Grounded on nonstop analysis performed since the onset of the epidemic, all Roche molecular tests, including the cobas SARS- CoV- 2 Qualitative test, descry all SARS- CoV- 2 variants.
Roche( SIX RO, ROG; OTCQX RHHBY) moment blazoned that theU.S. Food and Drug Administration( FDA) has granted 510( k) concurrence for the cobas ® SARS- CoV- 2 Qualitative PCR test for use on the completely automated cobas ® 6800 and cobas ® 8800 Systems. This standalone test is intended for the qualitative discovery of SARS- CoV- 2, the contagion that causes COVID- 19 complaint, in nasal and nasopharyngeal samples from characteristic cases who are suspected of having COVID- 19 as determined by their healthcare provider.
The cobas SARS- CoV- 2 Qualitative test has been available in theU.S. under Emergency Use Authorization( EUA) since March 2020 and was the first marketable molecular test to admit this status. The FDA concurrence is grounded on a comprehensive package submitted to the agency, including logical and clinical studies.
“ We’re pleased that we’ve achieved this nonsupervisory corner. Roche is completely committed to continuing our support and invention for COVID- 19 diagnostics to address evolving health care requirements and to help keep communities safe, ” said Thomas Schinecker, CEO of Roche Diagnostics. “ We’re laboriously working with health authorities to pursue FDA- cleared status for the tests in our COVID- 19 portfolio. This will insure clinicians and cases have continued access to accurate, dependable and effective testing options. ”
With the continued elaboration of coronavirus variants and frequent surges passing around the world, Roche will continue to add individual results to the global portfolio to help in the fight against COVID- 19. For further information on how Roche is responding to the global COVID- 19 public health extremity, please visit our COVID- 19 response runner.
About the cobas SARS- CoV- 2 Qualitative assay
The cobas SARS- CoV- 2 Qualitative assay is a single- well-conditioned binary target assay, which includes both specific discovery of SARS- CoV- 2 andpan-sarbecovirus discovery for the sarbecovirus subgenus that includes SARS- CoV- 2. The test is a real- time RT- PCR test intended for the qualitative discovery of nucleic acids from SARS- CoV- 2 in nasal and nasopharyngeal tar samples collected from characteristic individualities suspected of COVID- 19 by their healthcare provider. The test runs on the cobas6800/8800 Systems and has a full- process negative control, positive control and internal control.
Negative results don’t avert SARS- CoV- 2 infection and shouldn’t be used as the sole base for patient operation opinions. Results are meant to be used in confluence with clinical compliances, patient history, recent exposures and epidemiological information, and laboratory data, in agreement with the guidelines handed by the applicable public health authorities.
The cobas ® SARS- CoV- 2 Qualitative assay is intended for use by good clinical laboratory labor force specifically instructed and trained in the ways of real- time PCR and on the use of the cobas ®6800/8800 Systems.
About the cobas6800/8800 Systems
The Roche cobas6800/8800 Systems, which are used to perform the cobas SARS- CoV- 2 test, give results in three and partial hours and offer bettered operating effectiveness, inflexibility, and fastest time- to- results with the loftiest outturn furnishing up to 96 results in about three hours and a aggregate of,440 results for the cobas 6800 System and,128 results for the cobas 8800 System in 24 hours. The test can be run contemporaneously with other assays handed by Roche for use on the cobas6800/8800 Systems.
For further information about the tests and system, please visitwww.diagnostics.roche.com.
About Roche
innovated in 1896 in Basel, Switzerland, as one of the first artificial manufacturers of ingrained drugs, 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 drugs and diagnostics for perfecting and saving the lives of people around the world. We’re a colonist in personalised healthcare and want to further transfigure how healthcare is delivered to have an indeed lesser impact. To give the stylish care for each person we mate with numerous stakeholders and combine our strengths in Diagnostics and Pharma with data perceptivity from the clinical practice.
In feting our bid to pursue a long- term perspective in all we do, Roche has been named one of the most sustainable companies in the medicinals assiduity by the Dow Jones Sustainability indicators for the thirteenth successive time. This distinction also reflects our sweats to ameliorate access to healthcare together with original mates in every country we work.
Genentech, in the United States, is a wholly possessed member of the Roche Group. Roche is the maturity shareholder in Chugai Pharmaceutical, Japan.
Source link:https://www.roche.com/
