The current state of antibody testing for COVID-19 is “a disaster,” said Roche CEO Severin Schwan, as a large number of potentially inaccurate tests enter the market fueled by sky-high demand.
Many countries are seeking serology tests to better understand whether people are developing a possible immunity to the novel coronavirus. But reports detailing high rates of false-positive and false-negative results are delaying widespread screening.
“These tests are not worth anything, or have very little use,” Schwan said during an early Wednesday conference call regarding the company’s first-quarter earnings, according to Reuters.
“Some of these companies, I tell you, this is ethically very questionable to get out with this stuff,” he said, adding that Roche analyzed several products currently on the market and found them to be unreliable.
“Every kind of amateur could produce an antibody test,” he said. “The two of us could do it overnight in the garage.”
Roche is currently developing its own antibody test, set to launch in early May, which will run on its high-throughput Elecsys assay platform and cobas line of analysers. The company is working with the FDA to secure an Emergency Use Authorization, though the agency is currently allowing developers to distribute self-validated serology tests ahead of official review.
On a subsequent call with investors, Roche’s diagnostics chief Thomas Schinecker offered his view.
“From a technological perspective, with a test using a finger prick, you will never get as good a result as if you take the blood from the vein,” Schinecker said, describing the design of certain antibody and point-of-care tests, which use a simpler testing strip instead of laboratory hardware. “I would take those results with caution.”
In the first quarter of this year—which included the FDA’s fast emergency authorization of Roche’s molecular test for active cases of COVID-19—sales within the diagnostics division increased 5% to 2.9 billion Swiss francs, or just under $3 billion U.S.
Overall, molecular testing sales rose by 29%—strongly driven by emergency and COVID-19-related testing, though routine health checks decreased.
Additionally, growth was reported worldwide, save for the Asia-Pacific region, which saw an 11% drop following coronavirus-related shutdowns in China. Demand in North America, Europe and Latin America was less affected from January through March, the company said, due to the later onset of the pandemic in those regions.
Roche confirmed its outlook for the remainder of 2020, saying that its supply chain for medicines and tests remains intact and that sales are expected to grow in the low- to mid-single digit range driven by new drugs and diagnostics, including lab hardware.
“In a pandemic, your healthcare infrastructure is stretched,” Schwan said during the conference call. “I have no doubt in my mind, because now there is such a huge public awareness in countries where it is not working well and that it needs to be upgraded.”
“As far as Roche is concerned, I have no doubt that people will invest more in high-throughput testing systems,” he added. “The countries that had them did extremely well.”
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Roche is also developing its own multiplex assay as a point-of-care test for active infections, said Schinecker, though the company is working to overcome the trade-offs between accuracy and a test’s ability to produce a fast result virtually anywhere.
“We want to make sure we hit the target performance that lives up to the standard we set ourselves,” he said. “You want to make sure it performs as close to a lab test.”
And regarding serology testing, there are a lot of unknowns about how exactly the body’s production of antibodies will translate to immunity to the disease, or for how long.
“But society has no other chance than to work with these hypotheses,” Schinecker said. “We cannot wait for all the data to be there.”