Finding a Covid-19 test: ‘It was like learning to fly a jumbo jet in mid-air’

When the coronavirus pandemic struck, Finbarr Kenny was always going to find himself at the coalface.

As governments were thrashing about for answers, one of the first identified priorities was the need to test people and then trace contacts of those who were found to have the virus. “Test and trace become one of the early mantras from public health officials alongside ‘wash your hands’ and ‘social distancing’.”

When it comes to testing, Kenny's employer, Roche Diagnostics, is one of the main players worldwide and has strong links to the HSE.

“It varies country by country, but in Ireland we would be the predominant player within diagnostics and pathology,” says Kenny, who is director of the Swiss pharma giant’s diagnostics business in Ireland, where it employs about 50 people.

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The company offers 581 different tests that either screen for, diagnose or monitor various diseases. Kenny says such tests are used in 70 per cent of all clinical decisions made by doctors, making them an increasingly important element in healthcare.

He has seen both sides of the business, having started life as a “very keen” biomedical scientist “who started to ask too many questions”. That saw him move into research before switching 23 years ago to the commercial side of what he says is a fast-moving business.

Perhaps because of that market-leading position, Roche chose to bide its time as a wave of tests were offered to desperate governments worldwide – delivering sometimes less-than-accurate results.

It felt that there was a litany of other technologies that maybe had come too early, and that was not a space that Roche was willing to occupy

“I think when you look at the early response that industry took to the Covid pandemic, there was a rather rapid and maybe sometimes premature access to market for certain technologies,” Kenny says. “Nobody really knew how to respond to this pandemic. I’ve heard a beautiful analogy that it was like learning to fly a jumbo jet in mid-air. It was that level of response.

“It certainly felt that at the front end there was a litany of other technologies that maybe had come too early, and that was not a space that Roche was willing to occupy.”

Roche, he says, spends more than any other diagnostics company on R&D. “We innovate more than any other company in the diagnostic space, and that is actually also testimony to how fast we were able to accelerate from this very confident clinical and scientific position into the Covid response.”

When the company was ready, it arrived with a bang, unveiling its fully automated molecular test to determine if a patient actually had the Covid-19 coronavirus on the White House lawn with Donald Trump after a rapid approval by the FDA. "Since then we've become effectively the major player in molecular testing for Covid-19 analysis."

Presence of antibodies

This is the platform that the National Virus Reference Laboratory at UCD has been using during the crisis to test blood from patients around the State – taking over from another Roche platform that was in use in Ireland earlier in the pandemic. Another of the new machines has just been installed at Cork University Hospital and is due to go live at the end of this month.

When Taoiseach Leo Varadkar announced the shutting-down of the economy on St Patrick's Day, Roche started working to ramp up testing capacity for the HSE by 300 per cent before the new higher capacity machines arrived.

It took the same "measured" but "fast-tracked" approach more recently as governments looking to reopen the economy turned their attention to tests that would show whether people had overcome the virus, perhaps unwittingly, and now had antibodies that might indicate some level of immunity to reinfection.

While others rushed to market, Roche waited until it had a test that delivered 100 per cent sensitivity – accurately identifying those with antibodies – and 99.8 per cent specificity, the rate of correctly identifying those who do not.

At a time when some scientists and the wider public were beginning to question the value of tests, Kenny says Roche can be “very proud and confident that the tests that were produced [by it] are clinically relevant but also give full confidence to both clinician and patient alike”.

Recent reports have suggested that some of those who tested positive initially for coronavirus do not now have any antibodies in their system. Kenny says he is confident that anyone who has tested positive on a Roche molecular test will now show the presence of antibodies.

But plenty of unknowns remain even for those most familiar with the science – most particularly whether the presence of antibodies will deliver immunity.

The HSE has been validating the Roche antibody test, among others, and recently announced plans for a two-county study to assess the prevalence of antibodies in the population

“It’s almost too early to comment on that, because this is a virus that we haven’t seen,” Kenny says. “We still are in the point of understanding whether these antibodies are neutralising antibodies or whether these antibodies have longevity and whether these antibodies from your own immune systems can create memory, so that when you see the virus again, you will respond in a similar way.

“Right now what we can determine is whether someone has actually recently been infected with the virus and that has caused an immune response to that virus.”

The HSE has been validating the Roche antibody test, among others, and recently announced plans for a two-county study to assess the prevalence of antibodies in the population. How these antibody tests are applied in Ireland will ultimately be down to the National Public Health Emergency Team and the HSE.

‘Responsible’ pricing

Already the cost of testing has entered the public arena, with the HSE saying that it could face a bill of up to €450 million for testing by year end. Kenny is comfortable that Roche has not taken advantage of the crisis.

“I think, from the outset, Roche priced responsibly into the Covid pandemic,” he says. “The rationale for that is that we wanted to have a unique price that would allow for access to that test, where it was needed right across the world. There’s been no ramping, there’s been no alteration, there’s been no iterations ultimately with that price.

“Long term, of course, are there volume discussions and are there national strategies that also can take place on that? That’s actually for the Government then to engage with industry.”

Part of that equation will be planning for any second wave, or a separate pandemic altogether. Roche is now producing a pandemic plan, Kenny says, that can show what those costs might look like and what further investment may be needed.

"I think the HSE definitely have it in their near vision," he says, citing the potential for flu and Covid-19 arriving as twin threats in September or October

“If we were to follow the corona model, we should ensure that there is enough resilience within the HSE network to do molecular testing at that same scale, potentially higher, potentially lower, depending on the actual level of the pandemic within the HSE sites,” he says.

That would mean faster test results from the outset. It would also mean that the impact of any lockdown would be substantially reduced.

“I think the HSE definitely have it in their near vision,” he says, citing the potential for flu and Covid-19 arriving as twin threats in September or October.

And how does he sum up the experience of the past six months?

“It’s an amazing moment, a defining moment on the integrity and the values that you have as a company that you can walk away and say ‘We were there with the HSE, with the healthcare professionals, helping patients survive corona.’ ”