Roche launches its next-generation SARS-CoV-2 Rapid Antibody Test

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• The SARS-CoV-2 Rapid Antibody Test 2.0 is configured for broader use by healthcare professionals to now include vaccinated individuals, in addition to those who have recovered from infection.
• The SARS-CoV-2 Rapid Antibody Test 2.0 has also been updated to improve the detection of antibodies against variants of the virus, and continues to be investigated against new variants of concern.
• The test works seamlessly with navify® Pass, Roche's digital solution that allows individuals and healthcare professionals to immediately store, display, and share their COVID-19 test results and vaccination status.

ROTKREUZ, Switzerland, Oct. 3, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the SARS-CoV-2 Rapid Antibody Test 2.0 in markets accepting the CE Mark. The test is the next generation of Roche's existing SARS-CoV-2 Rapid Antibody Test, which launched in July 2020. The SARS-CoV-2 Rapid Antibody Test 2.0 offers broader use than its original configuration, which focused on recovered patients, to now include vaccinated individuals as well. The test has also been updated to improve the detection of antibodies against variants of the virus, and continues to be investigated against new variants of concern.

The SARS-CoV-2 Rapid Antibody Test 2.0 can be used by healthcare professionals in point of care settings outside clinical labs and near to patients with a capillary sample. The test should help healthcare professionals to identify patients that have developed antibodies against SARS-CoV-2, indicating prior infection or vaccination. The SARS-CoV-2 Rapid Antibody Test 2.0 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. Healthcare professionals can further use the test to help patients check their antibody status and to determine whether they still have a detectable antibody response from prior vaccination.

"The next-generation of our SARS-CoV-2 Rapid Antibody Test demonstrates Roche's continued commitment to innovate as the COVID-19 pandemic evolves," said Ian Parfrement, Head of Point of Care at Roche Diagnostics. "We are proud to introduce an improved antibody test that, given its point of care use, offers healthcare professionals greater speed and accessibility in providing the right care to those that need it."

The test's launch is in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and launched a range of rapid antigen and antibody tests in more than 50 countries worldwide. The SARS-CoV-2 Rapid Antibody Test 2.0 joins Roche's comprehensive diagnostic portfolio of solutions to help healthcare systems combat COVID-19, which also includes molecular, serology and digital solutions.

About the SARS-CoV-2 Rapid Antibody Test 2.0
Roche's SARS-CoV-2 Rapid Antibody Test 2.0 is a rapid chromatographic immunoassay intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood. This test can be performed using blood from a finger prick to produce high performance results within 10-15 minutes in a point of care setting. The results can help identify an adaptive immune response to the virus.

When performed 3-4 weeks after vaccination, when IgG antibody levels are anticipated to reach their plateau, the test has a sensitivity of 98.67% and 100.00% after the second and booster shot, respectively. When performed at least 15 days after symptom onset for a non-vaccinated population, the test has a sensitivity of 95.83% and a specificity of 100.00%.

The test's ability to detect antibodies after vaccination against SARS-CoV-2 was confirmed through a clinical trial which included patients vaccinated with vaccines from Moderna, Pfizer/BioNTech, AstraZeneca and Johnson & Johnson.¹

About antibody testing
The human body develops antibodies in response to many infectious diseases. In the current situation of the COVID-19 pandemic, tests to detect antibody responses to SARS-CoV-2 are 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 today, there is no common agreement in the literature on a given antibody level which would grant immunity to SARS-CoV-2 infection.

Antibody tests need to be able to specifically detect antibodies against SARS-CoV-2 with no cross-reactivity to other infectious agents, 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 SD Biosensor
SD Biosensor is a global in-vitro diagnostic company focused on the development of immunoassay and molecular diagnostic products at the point of care. Founded in 2010, SD Biosensor has continued to research and develop products that can aid in the fast and accurate diagnosis of patients across the testing journey. Through these innovative products, they are striving to become a leading global in vitro diagnostics company. For more information, please visit www.sdbiosensor.com.

About Roche's response to the COVID-19 pandemic
As a leading healthcare company, we are doing all we can to support countries in their fight against COVID-19 and minimising its impact. That is why we are working with governments, policy makers, healthcare professionals and others to help contain the COVID-19 pandemic and make sure patients continue to receive the tests, treatment and care they need.

The pandemic has profoundly raised awareness of the role diagnostics play in COVID-19 diagnosis, treatment development and disease management. Roche has developed and launched more than 20 COVID-19 diagnostics solutions, including polymerase chain reaction (PCR) and rapid antigen and antibody tests. Our solutions serve the entire diagnostic continuum, from high-throughput laboratories to point-of-care and home self-testing, and cover all currently known variants. To help meet global demand, we have supplied more than 1.5 billion tests for COVID-19 since March 2020.

Roche continues to evaluate its existing therapeutic portfolio and is researching future options to help benefit patients with COVID-19. Our IL-6 inhibitor Actemra®/RoActemra® (tocilizumab) has been approved for patients hospitalised with severe COVID-19 in more than 30 countries including the European Union and is authorised for emergency use in the United States. The World Health Organization has prequalified Actemra for use in patients with severe COVID-19, facilitating its availability in low- and middle-income countries. In addition, we have been improving access to Actemra by introducing an international differentiated pricing strategy, providing the medicine at cost for use in low- and middle-income countries and non asserting patents in these regions during the pandemic.

We have also been partnering with Regeneron to jointly develop the antibody combination Ronapreve™ (casirivimab and imdevimab, known as REGEN-COV™ in the US). It has been approved in multiple territories including the European Union, Japan, and Switzerland and authorised for emergency or temporary pandemic use in many countries including the US. The antibody combination has been made available to patients in more than 60 countries, across many geographies including low and middle income countries. As the virus continues to evolve, we are constantly monitoring Ronapreve's activity against emerging variants of concern, and will share results with health authorities as soon as possible.

Our utmost goal remains to be a trusted partner who acts with urgency to save and improve the lives of patients with COVID-19 and to reduce its burden on society. For more information please visit our COVID-19 response page.

About Roche 
Founded in 1896 in Basel, Switzerland, 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 personalised 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 recognising our endeavour 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.

References
[1] SD Biosensor. (2022). SARS-CoV-2 Rapid Antibody 2.0 package insert.

For further information please contact:

For further information please contact:
Jeffrey Matthews, Head of Communications, Point of Care, Roche Diagnostics Communications
E-mail: [email protected]

Jonathan Parry, Senior Communications Manager, RDS Portfolio Center of Excellence
E-mail: [email protected]