Roche Launches Serology Test to Uncover COVID-19 Antibodies

Roche recently announced the development of a serology test to detect antibodies in individuals who have been exposed to COVID-19. 

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The Anti-SARS-CoV-2 serology test, Elecsys, is designed to identify individuals who have been infected by the virus, especially those who do not display any symptoms. The test can also screen high-risk groups including healthcare workers and food supply workers who may have developed immunity and can safely return to work. 

“Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May,” Severin Schwan, CEO of Roche Group said in the announcement. 

“Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”

Once experts understand more about the immunity of COVID-19, potential drug and vaccine options will advance and help society return to normality faster. 

“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. "Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”

The immunoassay is an in vitro test that uses human serum and plasma drawn from a blood sample to detect antibodies and determine the body’s immune reaction to SARS-CoV-2, the announcement stated.

The test may also be used in epidemiological research to uncover the spread of the disease and may also be used simultaneously with molecular tests to help the diagnosis of potential COVID-19 patients. Hospitals and other laboratories can leverage the test on Roche’s cobas e analyzers.

Roche expects the antibody tests to be available in early May and is working with FDA for an Emergency Use Authorization (EUA). The company will boost monthly production to double tests by June and will scale up production as quickly as possible. 

Recently, CMS released guidance forcing private health plans to cover diagnostic testing. One of the covered procedures includes coronavirus antibody testing. 

Although antibody testing is not widely available, various pharmaceutical companies including Pfizer Eli Lilly and Company are launching initiatives and partnerships to explore antibody testing potential. 

Earlier this week, Lilly announced that it partnered with the National Institutes of Allergy and Infectious Diseases (NIAID) to study baricitinib as part of NIAID’s Adaptive COVID-19 treatment clinical trial. 

NIAID, part of the National Institutes of Health (NIH), and Lilly will advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19.  

The antibody will be tested in COVID-19 patients who are at higher risk of progressing to acute respiratory distress syndrome (ARDS).

The Pfizer initiative, the COVID-19 Therapeutics Accelerator, will identify, assess, and scale-up treatments to make products available and affordable for vulnerable communities. It will screen thousands of compounds with safety data and consider new investigational compounds and monoclonal antibodies. 

The antibodies that pass the initial screening test will be developed by an industry partner. 

“We are in the midst of a global health crisis and understand the need for immediate and significant philanthropic and private sector contributions to help sustain local and global partners on the front lines of the pandemic response, with the goal of saving lives,” Caroline Roan, president of The Pfizer Foundation and vice president of global health & patient access of Pfizer, said in the announcement.