NEW YORK – During its conference call on Wednesday to discuss its first quarter financial results, Roche detailed the development of its SARS-CoV-2 serology test and further defined its manufacturing capabilities.
The Elecsys Anti-SARS-CoV-2 assay is expected to launch in May and will run on the Cobas e systems, according to the company. Roche has an installed base of more than 40,000 of the Cobas e instruments, including the e 411, the e 601/602, and the e 801, which it plans to utilize to ramp up serology testing for a wider population, Roche CEO Severin Schwan said on the call.
The assay will be used to identify people who have been infected with SARS-CoV-2 but may not know it because they had mild or no symptoms. Roche Diagnostics CEO Thomas Schinecker said the company expects to ramp up to high double-digit millions per month serology testing volumes by June. He added the company will continue to ramp up capacity from there.
Roche is still validating and finalizing data on the serology test and expects to have it completed by the end of this week. Schwan emphasized that the company has enough data to ensure the test "will be a highly precise and reliable test."
He noted that developing an antibody test also required some luck. "The good news is we had the right targets among those which we investigated and that allowed us to also achieve these levels of specificity and sensitivity."
Schinecker also emphasized the importance of specificity. "Specificity is the most important number to look at because you don't want to have any false positives," he said. "If the amount of people that have been infected is still very low, specificity is critical in order to make sure that you understand who is truly positive." False positives have been a cause for concern for many serology test developers.
Schinecker said Roche designed the sandwich assay using two antigens specifically because the company believes it can achieve a higher level of specificity. He added "you want to get the number as close to 100 as possible," but noted that fully reaching 100 percent is impossible. "If you have 100 percent, basically, you didn't test enough samples," Schinecker said.
He also said Roche started the development process with more than 60 different antibody tests before narrowing it down to the Elecsys Anti-SARS-CoV-2 test. "The antibody test is key to understand whether or not the population will develop immunity, and potentially also the amount of antibodies that have been developed," Schinecker said, but he also noted that the virus is still new and more data is needed to understand if there's immunity and how long that immunity will last.
He added the company is also looking into a point-of-care serology test but said getting the same performance from a strip test as a lab test was impossible. "Looking at tests in the market, there is a wide range of performance," Schinecker said. "From a technological perspective, if you do a point-of-care lateral flow test and you take it from a finger prick, you will never get as good a result as when you take it from the vein and you run it on these high performance systems."
So far, the only coronavirus serology tests that have received Emergency Use Authorization from the US Food and Drug Administration are for use with laboratory-based systems. The point-of-care or decentralized SARS-CoV-2 tests to have received EUA, such as tests from Abbott Laboratories, Danaher's Cepheid, and Mesa Biotech, are molecular-based.
Despite the turbulence of the COVID-19 pandemic, which resulted in significantly decreased routine testing volumes for Roche, Schwan noted the strong demand for molecular tests and said he expected probable upside from the antibody test.
Beyond its planned serology test, Roche currently has a molecular test available for SARS-CoV-2 testing running on the Cobas 6800 and 8800 systems that has received FDA EUA. The test was launched toward the end of March and only had two weeks of sales during the first quarter but had a significant impact on the company's molecular diagnostics revenues. Right now, Roche has more than 850 Cobas 6800/8800 systems on the market and is continuously installing more because there's a huge demand to meet high-throughput needs. Schinecker said the level of detection for the Cobas SARS-CoV-2 test is 24 copies of the virus per milliliter.
The company also has its lower-throughput TIB Molbiol LightMix Modular primers and probes for screening and confirmation, which are CE approved and cleared for research use only in the US. The LightMix assays run on Roche's MagNA Pure 24/96 and LightCycler 480 instruments. Multiple labs that have developed their own SARS-CoV-2 test also run their tests on the LightCycler, Schinecker said.
In the past four weeks, Roche has provided 15 million tests for COVID-19, Schinecker said. He added that the Cobas 6800/8800 automation makes a big difference, since there are so many samples that need testing, which could lead to a significant backlog.
Schinecker noted Roche has seen extremely high demand for its tests and systems and has been contacted by governments around the world looking to prepare for future waves of the coronavirus or future pandemics. He added the Cobas systems are ideal for these situations, due to their high throughputs, and said he believed Roche would have a higher installed base after the pandemic. He also said antibody testing is of high interest to governments, specifically to test healthcare workers to see who has been infected already.
When asked whether the company was planning to develop a molecular point-of-care SARS-CoV-2 test, Schinecker said they were working on it, but noted the company wanted to make sure it performs as well as the lab test and hits the target performance. If the company does launch a point-of-care test, Schinecker said it would be a multiplex assay including influenza A and B as well as SARS-CoV-2.