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Switzerland's Roche joins global race to make coronavirus antibody tests

[April 17, 2020] By John Miller

ZURICH (Reuters) - Swiss drugmaker Roche aims next month to be able to offer blood tests to identify those who have been infected with the coronavirus, joining a huge global push to inform locked-down nations about who might have some immunity and return to work.

Governments and businesses are seeking out such tests, to help them craft strategies to end lockdowns that have battered global economies even though it is not yet certain if those infected develop immunity to the new virus as with many other illnesses.

Roche's announcement on Friday follows others including U.S.-based Abbott Laboratories, Becton Dickinson and Co, Italy's DiaSorin that aim to develop and sell tests to identify antibodies.

"This is the working assumption: If you test and find people that have developed these antibodies, then at least for a certain period of time they will have gained immunity," Thomas Schinecker, Roche's diagnostics head, said.

"We worked day and night on this, over weekends, to make sure we can help as many patients as possible," Schinecker told Reuters.

The Basel-based company pledged to make its antibody test available by early May in countries that accept European CE regulatory standards, and is seeking Food and Drug Administration emergency authorisation for U.S. use.

It plans by June to boost production to "high double-digit millions" per month, with the tests due to be run on more than 40,000 of Roche's cobas e testing machines installed worldwide. The test identifies antibodies including immunoglobulin G (IgG), which remains longer in the body, suggesting possible immunity.

Countries have various plans to use such tests to better understand the COVID-19 illness caused by the virus, while also identifying those who were infected but showed only mild symptoms, or none at all.

Diasorin SpA of Italy is among those developing an antibody test which it hopes to put to use this month.

Chief Executive Carlo Rosa told Reuters last week that demand is immense, a situation that parallels the global scramble for ventilators to keep critically ill patients alive.

"We won't be in a position to respond to the enormous demand that there will be for these tests on our own," said Rosa, adding Diasorin has 5,000 testing platforms installed globally, including 500 in Italy, which can process 170 samples an hour.

Authorities in the Italian regions of Veneto and Emilia Romagna have already begun testing health workers and authorities in hard-hit Lombardy where thousands have died are planning an antibody screening from April 21.

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Finland, Germany, Britain and other countries have antibody testing plans, too, while the U.S. Centers for Disease Control and Prevention is using them to study community-wide transmission.

It is not yet clear how conflicting demands from governments and businesses will be managed.

Amazon.com has voiced interest in testing, but in Spain, the purchase by Siemens wind turbine maker Siemens Gamesa Renewable Energy SA of 2,000 assays to test employees, prompted the Spanish government to requisition the tests, union leaders said.

IMMUNITY OR NOT?

In Roche's home country of Switzerland, officials are examining antibody tests in trials underway in Geneva's university hospital, while still warning that too little is known about the new coronavirus to conclude a positive test offers conclusive evidence of immunity.

"What you can't say, and that's this idea that's going around, is that if I have the antibodies, then I know if I'm immune or not," said Patrick Mathys, the Swiss health ministry's crisis management head. That will take more research.

A spokesman for the ministry said antibody tests are foreseen playing a role for future steps to lift the country's restrictions like bans on group gatherings and school closures.

For now, the Swiss government is basing its decision to start easing curbs on April 27 on slowing rates of new infections, hospitalisations and deaths. Before antibodies play a role, "first we've got to have validated tests," the spokesman said.

Even tests with high accuracy have weaknesses, potentially producing thousands of false positive results. False positives could lead someone to believe they have immunity when in fact they have none.

Roche's tests have met the company's accuracy expectations, Schinecker said, though it is not yet releasing data.

"We put our best scientists on this," Schinecker said. "What we see is that the way we've designed the assay, it's extremely specific."

(Reporting by John Miller in Zurich and James; Mackenzie in Milan, additional reporting by Gincarlo Navach in Milan; editing by Bill Berkrot and Elaine Hardcastle)

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