Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisionsAntigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection statusAffordable and small, instrument-free testing kit enables convenient use for healthcare professionals at different point of care locations, or in resource-limited settingsPoint of care testing increases access to high quality diagnostics solutions for the detection of a current SARS-CoV-2 infection, regardless of laboratory testing infrastructure or patient mobility
Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, andEnsuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July, we added a Rapid Antibody Test, with SD Biosensor as distribution partner, to our portfolio, that allows the detection of antibodies against Covid-19 at the point of care. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
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