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Roche Continues Expanding Diagnostic Portfolio for SARS-CoV-2 and Beyond

NEW YORK – While the COVID-19 pandemic has led Roche, and other diagnostic companies, to zero in on a virus and disease few knew about this time last year, the demand for other diseases hasn't let up.  

On a conference call on Thursday to discuss third quarter financial results, Roche leadership addressed the company's continuing portfolio of SARS-CoV-2 tests but emphasized other molecular tests are still being developed and rolled out as usual.

So far, the company has 13 SARS-CoV-2 tests available in the EU, including multiple high-throughput, RT-PCR assays; a rapid antigen test; two multiplex SARS-Cov-2 and influenza A/B tests; and multiple antibody tests. The rapid antigen test, the rapid antibody test, and the Cobas Liat multiplex assay for SARS-CoV-2 and influenza were launched toward the end of the third quarter, so there was little impact on Roche's business in that quarter, but contributions from both are expected to be significant in the following three months, company officials said.

The rapid antigen test is instrument-free, delivers results in 15 minutes, and has a specificity of nearly 100 percent and sensitivity of nearly 97 percent, matching Quidel and Abbott's listed sensitivities for their antigen tests. Roche's test has received CE marking and is currently under consideration for Emergency Use Authorization by the US Food and Drug Administration. Roche is currently producing more than 40 million antigen tests per month, with launches in more than 100 countries.

The multiplex Cobas SARS-CoV-2 and influenza A/B test, for use on the Liat system, can differentiate between the viruses in 20 minutes at the point of care. There are more than 5,000 Liat instruments installed globally, Roche Diagnostics CEO Thomas Schinecker said, though with an expected volume of less than 1 million per month, the test's impact will be less than the rapid antigen test. Schinecker didn't mention plans to ramp up that manufacturing figure on the call.  

Other tests are in the works, according to Schinecker, who said on the call the company is currently developing three SARS-CoV-2 tests: a rapid antigen SARS-CoV-2 test for use with saliva samples at the point of care, a rapid antigen SARS-CoV-2 and influenza A/B point-of-care test, and a rapid antigen test for use in the clinical laboratory. These tests are expected to launch in the fourth quarter of 2020.

The Elecsys Anti-SARS-CoV-2 antigen test, which will run in clinical laboratories, can perform 300 tests per hour with each result in 18 minutes, Schinecker said. He also noted that there are currently more than 70,000 Elecsys instruments installed around the world, providing a large base for Roche. 

Both Schinecker and Roche CEO Severin Schwan emphasized the role a rapid, high-throughput antigen test could play to increase capacity. "It's pretty clear that at least until the middle of next year, that the demand is still going to be significantly higher than supply," Schinecker said. In his view, there will be no reserves of PCR tests for SARS-CoV-2, at least in the first half of next year. This demand is why "we believe antigen tests are extremely important, because they can complement the PCR tests," he added.

Schwan noted on the call that there are constraints on PCR testing already, saying "We as an industry will never be able to provide PCR tests for the masses, it's just not possible." Antigen tests, however, can be scaled up and bringing antigen tests to high-throughput systems can provide relief for the testing ecosystem and overall healthcare system, he continued. 

In addition to tests specific to SARS-CoV-2, Roche has also launched a multiplex respiratory panel test for the Cobas 6800/8800 instrument that can run a panel detecting 15 different viruses per well, including SARS-CoV-2. 

Beyond the respiratory sphere, Roche launched multiple other diagnostic tests in the third quarter and has plans for more in the coming quarter, Schinecker said. The company plans on launching a three-test antibody panel running on the Elecsys instrument to identify Epstein-Barr virus. The test is currently in development and will be used for organ transplant patients pre-transplantation to determine the infection stage of both the donor and the recipients.

Roche has also launched two Cobas tests, one to determine Epstein-Barr and one for BK virus to monitor high-risk transplant patients after transplantation. Both Cobas tests have been cleared by the FDA, with the BK virus test receiving 510(k) clearance last month and the EBV test being cleared for use in August. 

In the US, Roche launched a Cobas 6800/8800 test for HIV that can differentiate between HIV-1 and HIV-2 to help diagnose the virus, Schinecker said. The test received approval from the FDA in September. There are 1,000 Cobas 6800/8800 instruments installed globally, and the company expects the installed base to double within a year, Schinecker said.  

The company has launched a combination antigen and immunoassay Elecsys test for HIV diagnosis that is used in blood screening outside the US, and that Schinecker called "best in class."

Manufacturing capacity has continued to be a concern for the diagnostics industry as a whole, as demand for SARS-CoV-2 tests outpaces supply. Schwan said Roche would continue to ramp up its COVID-19 manufacturing into the fourth quarter, and Schinecker added that as soon as Roche saw how the pandemic would develop, it began using backup tools to increase its manufacturing capacity. Some additional manufacturing lines came up this past summer and they're expecting more to come in the following months, increasing the supply of PCR tests.

The demand for antibody tests for the coronavirus has also continued, with Schinecker saying there has been a constant 10 million per month demand for Roche's Elecsys Anti-SARS-CoV-2 antibody test launched in May. Roche also has a CE-marked quantitative antibody assay being used in vaccine trials, he said. The antibody tests are being used to understand prevalence and immunity and to monitor people on a regular basis, as well as to aid in developing a vaccine. Schinecker continued that "once vaccines will come to the market, antibody testing will become definitely a lot more relevant going forward."

One emphasis for the company is on expanding its testing menu on high-throughput platforms. Schwan said that at some point, COVID-19 diagnostic testing will come down, but screening for SARS-CoV-2 and other diseases, such as human papillomavirus, will continue, as governments finally have invested in high-throughput systems as a result of the coronavirus pandemic.

"What we would hope for from a business point of view is, first of all, we gain market share because we have the high-throughput systems," Schwan said. "If at some point [hospitals and labs] are over capacity, they will go for the high-throughput systems where there is less labor needed and where there is high automation."