The Wider View: Lab-is-fab message underlies Roche’s COVID-19 testing discourse

Roche’s IVD business is expecting to gain not only from this pandemic but also in the longer term with increased awareness among policy-makers of high volume, high performance diagnostics. 

What’s happened

Roche’s Q1 2020 results showed a 5% constant currency growth in diagnostic sales, which the company said was in line with its expectations. The revenue mix was very different from what had been expected at the start of the year due to the escalation of the COVID-19 outbreak and the surge in demand for Roche’s COVID-19 molecular tests. The Swiss pharma and diagnostics giant reported a drop in sales for its centralised routine testing business while its diabetes care unit continued to be impacted by pricing pressures, but this was more than offset by its molecular diagnostics business - that encompass the COVID-19 nucleic acid tests and the instruments on which they run - which reported 32% underlying growth. 

The wider view

Roche’s diagnostics performance is consistent with that of its peers who were also early arrivals in the COVID-19 testing landscape with their respective tests. Roche’s top line, however, may have gained that extra lift as not only was it the first to bring out a commercial COVID-19 PCR test but it has arguably the biggest installed base of high throughput analysers globally. 

While its COVID-19 PCR tests are bringing in the cash for the company, most of the diagnostic-related questions for Roche’s executives during its earnings conference call was focused on the upcoming antibody test that is expected to be launched next month. 

There is always much excitement around antibody tests for COVID-19 because of the promise it holds of the potential easing of lockdown measures, whether for particular communities like key workers, or for the wider population. 

The US FDA has started authorising a number of antibody tests and Roche’s rival Abbott has already launched a lab-based antibody test while another lateral flow version is on its way.

But along with the excitement there is also a large dose of skepticism around how well these antibody tests perform, with specificity being a particularly thorny issue [see Spotlight On: COVID-19 Testing - Insights Into Some Whats And Whys for some background on antibody testing]. 

Thomas Schinecker, CEO of Roche Diagnostics, told investors at the conference call that it is "still finalising the data" on the sensitivity and specificity of its antibody test and will communicate that information when it launches the product next month.  

He did point out that the way Roche designed the test - a sandwich assay that uses two antigens and also includes chaperone molecules - enables it to achieve a higher level of specificity.  "We’ve used proprietary technology we have in-house - that's the benefit of having pharma and diagnostics under one roof - so we can design at a very high level," he said. "We started with more than 50 different antibody tests, we didn't just start with one, and we did everything in parallel so we can arrive at the best solution as quickly as possible."

Group CEO Severin Schwan added that when developing an antibody test, "you need a little bit of luck." "The good news is that we had the right targets among those which we investigated and that allowed us to achieve the levels of specificity and sensitivity which, you will see, is pretty astonishing," he said. 

The antibody tests will run on Roche’s lab-based cobas e systems, of which there are over 40,000 units installed globally, according to the company.

When asked to comment on the WHO’s advice to practice caution around antibody testing due to their questionable specificity levels, Shinecker acknowledged that there are wide variations in performance among the antibody tests - many of which are rapid point-of-care tests done on small blood samples - that are already out in the market. "From a technological perspective, if you do a lateral flow test and take it from a fingerprick sample, you will never get as good a result as if you run it on the lab-based systems." 

The same argument applies to why the firm won't be launching a point-of-care COVID-19 molecular diagnostic, like Abbott’s ID NOW test. "You will never get the same performance with a POC test as you do with a lab test. It's that simple," he reiterated.

As a key manufacturer of these high throughput, lab-based analysers, Roche stands to gain from the increased awareness of governments around the world to have the capacity for high volume testing. 

Roche's increase in diagnostic sales comes not only from very high demand for the tests but also the analysers, and Shinecker said that the firm has been contacted by governments who want to invest in their healthcare infrastructure and put more high throughput systems, like the cobas 6800 and 8800, in place in preparation for future waves of viral outbreaks. "The feedback is that these systems are ideal for this kind of [pandemic] situation. So there is high interest in governments to purchase more of these instruments; we think there is going to be a higher demand now and also going forward," he said, adding this will not only benefit Roche but also the wider IVD industry. 

"Diagnostics has been underestimated for a long time, not only from the complexity perspective but also the value it brings to society, to patients. It will definitely be a different [environment] for diagnostics going forward."

 

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