FDA Approves Roche Covid-19 Test that Aims to Test Vaccines’ Antibody Response

 

The U.S. Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood. The test appears to be geared toward measuring the antibody response produced by the vaccines currently under review. 

“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against Covid-19. Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response,” Roche Diagnostics’ CEO Thomas Schinecker said in a press release.

Roche explained that the test, Elecsys ® Anti-SARS-CoV-2 S, works by targeting “antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell.”

Pfizer and Moderna’s vaccines each target the spike (S) protein – a knobby protrusion on the SARS-CoV-2 virus that allows the virus to attach and invade cells, instigating infection. Pfizer’s vaccine received temporary authorization just this morning in the UK, the first official signal that we are entering the next phase of this fight where tests like Roche’s will play a significant role. 

Elecsys ® specifically detects antibodies against this S protein found within blood samples.

Roche added that “the test may help guide the allocation of plasma donations from recovered Covid-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus.”

Donors possessing these antibodies can contribute plasma to initiatives such as the CoVIg-19 Plasma Alliance, spearheaded by 12 plasma-focused Life Sciences companies such as CSL Behring and Takeda Pharmaceutical, to develop a plasma-based hyperimmune globulin intended for the hospitalized treatment of patients at risk for complications. 

The test has a lot of logistical upside as well, as Roche said that clinical laboratories can run it on their own widely-available cobas e analyzer units, and can receive results in approximately 18 minutes, with a test throughput of up to 300 tests per hour. Roche will begin shipping the test to U.S. laboratories within the next week. 

Elecsys ® was approved in the EU in mid-September in markets that accept the CE mark – a designation which shows that products sold conform with European health, safety, and environmental protection standards.

In the U.S., Roche joins Siemens, which was the first company to have a COVID-19 antibody-estimation test approved by the FDA in July.