Worldwide countries are looking towards serology testing in order to gain a better understanding of whether citizens are developing immunity against COVID-19, but reports detailing high rates of either false positives or false negatives 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 working on developing its own antibody test which the company says should be set to launch in May. Their test will run using the company’s high throughput Elecsys assay platform and conas line of analysers which the company is working with the FDA to secure an Emergency Use Authorization for, that allows developers to distribute self validated serology testing ahead of an official review.
Roche’s diagnostic chief Thomas Schinecker has offered his view in another interview: “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.”
So far this year the FDA has fast tracked the emergency authorization of Roche’s molecular test kits for active cases of COVID-19 infection and the sales within this diagnostic division have increased 5% to reach about $3 billion. Overall molecular testing sales have increased by 29% which has been largely driven by this recent outbreak with routine health checks decreasing.
Growth has been reported around the globe with the exception of the Asia Pacific region which had an 11% drop following COVID-19 related shutdowns in China; due to later onset of the outbreak demands in Europe, North America, and Latin America has been less affected in the first quarter. The company says that its supply chain for medicines and tests remains intact and that sales are expected to continue to increase driven by new drugs, diagnostics, and lab hardware.
“In a pandemic, your healthcare infrastructure is stretched,” said Schwan. “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.”
The company is working on developing its own multiple assay as a point of care test for active infections, and they are making strides towards overcoming the trade-offs between accuracy and ability to produce fast results virtually anywhere, says Schinecker.
“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.”
As far as serology testing goes there are still a lot of unknowns about exactly how the body’s production of antibodies will actually translate to immunity to disease or for how long, especially for a novel one such as it is with this outbreak of COVID-19.
“But society has no other chance than to work with these hypotheses,” Schinecker said. “We cannot wait for all the data to be there.”
