Media Release

28.07.2020

Roche launches rapid test for the detection of antibodies to SARS-CoV-2 to add a point of care testing solution to the fight against COVID-19

  • This test can help to reliably triage patients at the point of care and offer short time reassurance of prior infection
  • A small blood sample, that can be easily collected from a minimally invasive finger prick by a healthcare professional, is sufficient to perform the test when venous blood draw is less accessible or suboptimal for the patient
  • Portable testing kit enables its convenient use at versatile point of care locations, or in resource-limited settings
     

Basel, 14 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) recently announced the launch of the rapid antibody test for the detection of antibodies to SARS-CoV-2 in markets accepting the CE Mark. The launch is a partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement. Our partner, SD Biosensor is actively working on an Emergency Use Authorisation (EUA)[i]  submission to the U.S. Food and Drug Administration (FDA).
 

This newly developed rapid antibody test is for use in point of care settings and can help healthcare professionals identify patients that have developed antibodies against SARS-CoV-2, indicating prior infection. The test is part of the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19, which also includes molecular, serology and digital solutions.

Rapid test EDIT
Rapid test EDIT

The rapid antibody test can be performed by healthcare professionals in a number of settings outside clinical labs and near to the patient. This is beneficial in situations where timely decisions are needed, laboratory SARS-CoV-2 testing is not available, or finger prick sampling is the better option over a venous blood draw.

Thomas Schinecker, CEO of Roche Diagnostics, stated that, “We have a global responsibility to help better manage the COVID-19 health crisis and provide solutions to our patients when and where needed. We are proud to have an antibody test for the point of care now included in our COVID-19 diagnostic portfolio.”
 

Thomas Schinecker, CEO of Roche Diagnostics, stated that, “We have a global responsibility to help better manage the COVID-19 health crisis and provide solutions to our patients when and where needed. We are proud to have an antibody test for the point of care now included in our COVID-19 diagnostic portfolio.”
 

About antibody testing 
The human body develops antibodies in response to many illnesses. In the current situation of the COVID-19 pandemic, tests to detect antibody responses to SARS-CoV-2 will be critical to support vaccine 

development, add to our understanding about the rate and spread of infection among populations and, if scientific evidence shows, to determine whether a person might have gained immunity against the virus. As of 24 April 2020, no data from studies evaluating whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans have been published.[i] Antibody tests need to be able to specifically detect antibodies against SARS-CoV-2 with no cross-reactivity to other infectious diseases, such as influenza, which could generate a false positive result. A false positive result occurs when a person (wrongly) receives a positive test result, when they should have received a negative result due to the absence of SARS-CoV-2 specific antibodies in their blood.
 

About Roche’s response to the COVID-19 pandemic

The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need.
 

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 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching software, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.

We are actively involved in understanding the potential of our existing portfolio and are researching options for the future. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.

In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
 

About SD Biosensor

SD Biosensor is a global bio-diagnostic company that provides in vitro products engrafted with innovative technologies. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin, and cholesterols globally, and with innovative products, are striving to become a leading global in vitro diagnostic company.