The Basel-based company said on Friday it wants to make the antibody test\u00a0available by early May in countries that accept European CE regulatory\u00a0standards, and is seeking U.S. Food and Drug Administration emergency\u00a0authorization for its use in the United States.<\/p>\n
It plans by June to boost test production to “high double-digit millions”\u00a0per month, said Thomas Schinecker, Roche’s diagnostics head.\u00a0<\/p>\n
Roche joins a global race in which U.S.-based Abbott Laboratories<\/a>\u00a0and Becton Dickinson and Co<\/a>, Italy’s DiaSorin<\/a> and others hope\u00a0to sell tests that demonstrate people’s immune systems have developed antibodies\u00a0in response to the new coronavirus.<\/p>\n While it is not yet known for sure if those who have been infected develop\u00a0immunity to the new virus as with many other illnesses, accurate antibody tests\u00a0are seen as essential to help nations craft strategies to end business and\u00a0travel shutdowns that have battered economies around the globe. <\/p>\n “This is the working assumption: If you test and find people that have\u00a0developed these antibodies, then at least for a certain period of time they will\u00a0have gained immunity,” Schinecker told Reuters. “We worked day and night on\u00a0this, over weekends, to make sure we can help as many patients as possible.”<\/p>\n Roche’s test, which differs from the PCR assays it also makes that use a\u00a0nose swab to identify active infections, will run on more than 40,000 of its\u00a0cobas e testing machines installed worldwide.\u00a0<\/p>\n Roche’s new test will identify immunoglobulin M (IgM) and immunoglobulin G\u00a0(IgG) antibodies. The body quickly produces IgM antibodies for the initial fight\u00a0against infection. IgG antibodies remain longer in the body, suggesting possible\u00a0immunity.<\/p>\n Countries have various plans to use such tests to better understand the\u00a0COVID-19 illness caused by the virus, and identify those who were infected but\u00a0showed only mild symptoms, or none at all.<\/p>\n Finland, Germany, Britain and other countries have antibody testing plans.\u00a0The U.S. Centers for Disease Control and Prevention plans to use them to study\u00a0community-wide transmission. <\/p>\n In Roche’s home country, Switzerland, officials are examining tests, but\u00a0warn excitement may be premature given positive tests may say little about\u00a0actual immunity.\u00a0<\/p>\n “What you can’t say, and that’s this idea that’s going around, is that if I\u00a0have the antibodies, then I know if I’m immune or not,” said Patrick Mathys, the\u00a0Swiss health ministry’s crisis management head. That will take more research.\u00a0<\/p>\n Even tests with high accuracy have weaknesses, potentially producing many\u00a0false negative and false positive results. False positives could lead someone to\u00a0believe they have immunity when in fact they had not been infected.<\/p>\n Roche’s tests have met the company’s own accuracy expectations, Schinecker said, though it is not yet releasing final figures.\u00a0<\/p>\n “We put our best scientists on this,” he said. “What we see is that the way we’ve designed the assay, it’s extremely specific.”<\/p>\n![\"Abbott](\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/09\/106489640-917tirrellbreaker.jpg\")
<\/p>\n![\"Antibody](\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/09\/106492380-cb200416brianweinstein.jpg\")
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