RIO DE JANEIRO, BRAZIL – Roche has developed an antibody test for Covid-19 that it plans to start selling early next month. The test joins a group of diagnostic tools that experts believe are required to remove the social distancing measures in place worldwide.
The test will screen blood samples for antibodies that show whether an individual has been infected with the novel coronavirus, the Basel-based company said. Monthly production could reach millions of units – in the double-digit range – by June.
“We will increase production very, very significantly,” said Thomas Schinecker, in charge of diagnostics at Roche, in a telephone interview. The company plans to take the same high-intensity approach to manufacturing the new test that has been used to produce the molecular tests, available since January. “We are working 24 hours, seven days a week.”
Antibody testing is critical to help identify individuals who have already been infected, perhaps unknowingly, and better understand the true scope of the pandemic. A large number of tests can help identify those who are presumably immune to the novel coronavirus. It can also be used in combination with other tests that seek to detect the virus in an individual’s nose or throat.
Dozens of smaller companies in Asia, Europe, and North America have already launched antibody tests or are in the process of validating kits that can vary in complexity, from types that need extensive laboratory resources to a simplified version, similar to a home pregnancy test. On Friday, Eurofins Technologies announced that it has received the CE (European Compliance) label for a number of antibody tests.
Roche said it intends to release the test in early May in countries that accept the CE seal for Europe and that it is working with the FDA, the US drug and food regulatory agency, to secure permission for emergency use. The company plans to publish figures on the test’s reliability when it is closer to launching the product.
The test will be available to hospitals and reference laboratories that have Roche’s “cobas e” module, a fully automated system that can produce 300 results per hour. A test takes approximately 18 minutes, according to the company.
Source: Bloomberg