Roche to introduce its coming- generation portfolio of SARS- CoV- 2 rapid-fire antigen tests( “2.0 ”) under CE Mark for tone- test and professional use
Broad and trusted portfolio of COVID- 19 rapid-fire tests feature innovative updates and enhanced performance, erecting on perceptivity gained throughout the epidemic
All tests now work seamlessly with navify ® Pass, Roche’s digital result that allows individualities and healthcare professionals to incontinently store, display, and share COVID- 19 vaccination status and test results through a unique data matrix
Roche maintains the capacity to give knockouts of millions tests each month to meet sustained high worldwide demand from individualities and healthcare professionals
Roche( SIX RO, ROG; OTCQX RHHBY) moment blazoned the launch of its coming- generation portfolio SARS- CoV- 2 rapid-fire antigen tests( “2.0 ”) for tone- testing and professional use in countries accepting the CE Mark. Distribution of the new rapid-fire test portfolio is projected to begin in the coming weeks.
In doing so, Roche builds upon one of the broadest portfolios of COVID- 19 rapid-fire testing results with three new test configurations that feature enhanced performance through the use of an bettered prisoner antibody and the addition of new digital data participating capabilities to all tests. Using nasopharyngeal and nasal tar samples, independently, the tests deliver dependable results in as many as 15 twinkles, abetting in the opinion of SARS- CoV- 2 infection in individualities with or without symptoms harmonious with COVID- 19.
“ The uninterrupted elaboration of the SARS- CoV- 2 contagion and COVID- 19 epidemic support the need for individualities and healthcare systems to have access to the most dependable rapid-fire testing results possible, ” said Thomas Schinecker, CEO, Roche Diagnostics. “ As a leader in individual invention, we’re proud to be one of the first among our assiduity to apply perceptivity gained from the once two times toward a coming- generation rapid-fire test portfolio. These tests are ready to support global society as we navigate this coming phase of the epidemic. ”
Roche maintains the capacity to give several knockouts of millions of each of the tests per month, with the option to snappily make up fresh capacity if demanded, to address sustained high worldwide demand for rapid-fire testing from governments, healthcare systems and individualities. The coming- generation test portfolio will be introduced in cooperation with SD BiosensorInc., with whom Roche has a global distribution agreement and preliminarily launched a range of rapid-fire antigen and antibody tests in further than 50 countries worldwide.
The tests join Roche Diagnostics’s broader COVID- 19 portfolio, which includes a wide range of molecular, serological and digital results that help diagnose and manage COVID- 19 during the original stages of infection, during the recovery phase, and following the resolution of infection.
About antigen testing
An antigen test detects proteins which are structural or functional factors of a pathogen and are veritably specific to that pathogen. In this case, the test would give a qualitative “ yes/ no ” answer on the presence of the antigen in the case sample and can be offered as a rapid-fire strip test that’s performed by healthcare professionals at the point of care or by individualities athome.However, it’ll bind to specific antibodies and induce a visually sensible signal on the test strip, generally with results ready in 15 twinkles, If the target antigen( in this case the nucleocapsid protein) is present in sufficient attention in the sample.2 A rapid-fire antigen test can reliably descry individualities with a high viral cargo allowing healthcare professionals to snappily identify those cases at the topmost threat of spreading the infection.
In general, antigen tests have a high particularity, however aren’t as sensitive as molecular tests that amplify the target DNA or RNA sequence in order to induce a( semi-) quantifiable signal to indicate the presence of the pathogen in a sample. thus, to make up for the implicit drop in perceptivity of an antigen test, negative results should be analysed together with fresh information, similar as the existent’s exposure history, clinical symptoms, and fresh test results to help guide the opinion and posterior treatment of the case.
About Roche’s response to the COVID- 19 epidemic
As a leading healthcare company, we’re doing all we can to support countries in their fight against COVID- 19 and minimising its impact. That’s why we’re working with governments, policy makers, healthcare professionals and others to help contain the COVID- 19 epidemic and make sure cases continue to admit the tests, treatment and care they need.
The epidemic has profoundly raised mindfulness of the part diagnostics play in COVID- 19 opinion, treatment development and complaint operation. Roche has developed and launched further than 20 COVID- 19 diagnostics results, including polymerase chain response( PCR) and rapid-fire antigen and antibody tests. Our results serve the entire individual continuum, from high- outturn laboratories to point- of- care and home tone- testing, and cover all presently known variants.
About SD Biosensor
SD Biosensor is a global in- vitro individual company concentrated on the development of immunoassay and molecular individual products at the POC. innovated in 2010, SD Biosensor has continued to probe and develop products that can prop in the fast and accurate opinion of cases across the testing trip. Through these innovative products, they’re seeking to come a leading global in vitro diagnostics company.
innovated in1896 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.