Roche Holding AG received emergency-use authorisation from the US Food and Drug Administration for its new test determining if someone has been exposed to Covid-19, according to a statement yesterday.
The Basel-based drugmaker said it has already started shipments and that as of May, tens of millions of the antibody test will be available in the US and much of Europe.
Governments are trying to learn how many people have been exposed to the coronavirus as they wind down social-distancing measures.
The restrictions on businesses have cost millions their jobs and the global economy is on course for its deepest dive since the Great Depression.
“Our best scientists have worked 24/7 over the last few weeks and months,” said Thomas Schinecker, chief executive officer of Roche Diagnostics.
Hospitals and reference laboratories can run the Elecsys Anti-Sars-CoV-2 test on one of Roche’s analysis platforms, the Swiss pharmaceutical company said.
Roche’s antibody test has a specificity of more than 99.8% and 100% sensitivity, meaning that it not only reliably identifies patients who’ve developed antibodies but also can filter out those who haven’t, reducing misdiagnoses.
With no vaccine available yet for the novel coronavirus, there have been proposals that people who have antibodies could be issued an “immunity passport” that would allow them to travel or return to work, on the assumption that they were safe from re-infection.
Yet the World Health Organisation has cautioned on the level of protection against a second infection that people who have recovered from Covid-19 will have.
Once any resistance to the coronavirus is better understood, the new test could help to assess who has built up immunity, Roche said.
In addition to the search for a vaccine, more than 100 different programmes have been launched to develop and test treatments.
These include everything from antiviral drugs and antibody-containing plasma from recovered patients, to traditional Chinese herbal medicine.
Gilead Sciences Inc’s antiviral drug remdesivir has been cleared by US regulators for emergency use in Covid-19 patients, becoming the first medication backed by early clinical data to be made available to fight the disease.
Schinecker said the company aims to more than double production of tests from about 50 million a month to significantly more than 100mn a month by the end of the year.
A false-positive result could lead to the mistaken conclusion that someone has immunity. Roche said its test relies on intravenous blood draws, with higher accuracy than finger-prick tests.
“If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve ... when you take blood from the vein,” Schinecker said.
“You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”
Similar antibody tests have also been developed by companies including US-based Abbott Laboratories, Becton Dickinson and Italy’s DiaSorin.
Abbott has said the specificity and sensitivity of its test are 99.5% and 100% respectively. Diasorin has said its Liason XL test has 97.4% sensitivity and 98.5% specificity.
As demand escalates for antibody tests, an array of distributors with no background or established testing competency have also joined the experienced companies in an all-but-unregulated marketplace in the United States, according to a Reuters investigation.
Roche did not disclose a price for its test but said that it would be identical worldwide.
Schinecker foresees a high need for testing healthcare workers and their families for exposure, and those who showed signs and symptoms, to see if they have antibodies.
While antibodies typically confer some immunity, Schinecker acknowledged that much remains to be learned about the novel coronavirus before drawing definitive conclusions.
“Since this virus is not well known, one can hypothesise, but the proof will take longer,” he said. “Testing these people ... is key to seeing whether or not people really have developed immunity.”
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