How Randox has designs on the future - and on saving lives

It was an ordinary Saturday night at the end of January when Jason O’Neill took a call from his boss.

It was 10.30pm and the Randox employee, who is a Team Leader in the company’s Molecular Diagnostics department, was sitting at home.

“I remember thinking to myself, this is unusual!” he laughs.

“I took the call and said, ‘yes John, what’s going on?’ He said, ‘we’ve been discussing the situation, and we think we need to start immediately on this assay. Every minute counts.’”

Jason continues: “He said, ‘would you mind coming in tomorrow morning?’, and I said, ‘no problem’.”

And that was the moment that the Queen’s graduate, who has been working for Randox for 11 years, realised just how serious and potentially life changing this unprecedented, new virus that went by the name of SARS-CoV-2 could be.

Hours later, he was in a lab with his colleague, and their work on finding a diagnostic test for this seemingly deadly disease had begun.

“I wasn’t one for Maths or English or anything like that when I was at school, but I really loved Biology, and also Art,” he tells me, as we go back to the similarly earlier days of his professional career.

“I did a Bachelor of Science in Anatomy at Queen’s University Belfast, which I enjoyed.

“The human body is a fascinating machine, so that led me into doing a degree at Queen’s.”

In his final year, Jason studied the area of ophthalmology - the eyes - for a practical project, which he really enjoyed.

“The project looked at vision loss and what causes people to lose their sight when they get older, and what we can do to prevent that.”

Jason’s next move was to study a PhD, and after that he got a job back at Queen’s, before finally coming to join the Randox family.

Explaining the backdrop to how the company embarked on their mission to provide special testing kits for Covid-19, he reveals that they “had just made a new respiratory array which was to be used for looking at colds and flu, pneumonia and other coronaviruses.”

He continues: “So because we had done that, it was very much fresh in our minds. And we were always thinking about bird flu and swine flu and any diseases that might pop up.

“We had been watching the media reports from before Christmas and early January about individuals in China who had come down with pneumonia, and they couldn’t tie down what was causing it, which is always a bit of an alarm bell.

“There was the chance that this was something dangerous, something that we didn’t know about.

“Then very soon after that reports came through to say that a novel form of coronavirus had been discovered.

“Here at Randox, we thought to ourselves, this could be dangerous, because obviously 2002/03 saw the SARS outbreak, which was a novel coronavirus and was very deadly.”

Jason and his colleagues followed the changing news from China closely, as initial reports claimed that the person who had been affected by it had been quarantined and the virus contained, and then changed as it emerged that

it had spread further into the community than originally believed.

He recalls the topics of conversation that he and his colleagues had in those early stages.

“We wondered if this was something we needed to start thinking about; would we need to do the testing, and if so, we knew that we would need tests to specifically detect Covid.”

He laughs as he recounts that Sunday morning he arrived at the Antrim facility to start work - only to find he was locked out.

“I don’t typically work at weekends, so I got to the gates and of course I couldn’t get in, because my pass wasn’t authorised for weekend work.”

After a few more false starts, Jason finally gained access to the building, and eventually, a lab he could work in with his colleague Gabriella.

“By the time we got all sorted it was half nine in the morning. We started work and I think we spent a good 10 hours that day working on an assay.”

To give context, Jason explains that what they managed to get done in those 10 hours, could quite easily take three months in pre-Covid, ‘normal’ times.

“It meant that by the end of that day, we had a good head start, and could come in on the Monday morning and place orders for the materials that we needed.”

He explains that the aim was to come up with an assay which would specifically detect RNA that was exclusive to Covid-19 - and not shared with colds, or flus, or any other kinds of respiratory viruses.

“In order to do that, we needed to know Covid’s genetic code, and that was released in mid January.

“We were able to access and retrieve that data, and we designed a component in the assay which we call a primer, which will stick to that sequence and nothing else, nothing non-Covid.

“Molecular diagnostics is our thing, it’s our area of expertise.

“We had other respiratory diagnostic products on the market, and we were able to take components of those other assays which were already in existence and had been developed pre-Covid, and we could just modify that existing platform to accommodate these new elements.

“So with these new components that we had designed, we could convert it into a SARS-CoV-2 assay.”

Just over two weeks after that first Sunday, Jason and his team, had “more than a prototype” ready.

“We had a design, and obviously whilst we weren’t able to sell it at that point, we had the design and the preliminary data to say that it was ticking all our boxes.

“We had been working long, long hours, and we were in a pretty good position after just two weeks.”

I cannot help but comment - with incredulity - on the haste of the whole operation.

Jason agrees that this it was, and assures me that it was necessary.

“We could see how quickly the situation regarding the spread of the virus was changing. It came to the point where we thought, this is going to go global, and we’re going to see it in Northern Ireland as well.

“So time was of the essence and lives were at stake.

“We needed to get something prepared quickly so that when it did reach our shores we had a system in place and that we could help.

“For us it was all about helping people get tested so they could be taken ‘out of circulation’, and isolated or quarantined, and not spread the virus further. It was about slowing the chain of transmission through the community.”

He agrees that the urgency of the situation was unprecedented, but his colleagues at Randox rose to this very new kind of challenge.

“Everyone sort of jumped in and helped out; we were working weekends and there were times we worked through the night.”

I observe that it sounds like something out of a Hollywood blockbuster and he agrees with a laugh.

“It was kind of fun too.”

But on a serious note, Jason unsurprisingly admits to a sense of pride in the work that he and his colleagues have done.

“I’m very glad that we were able to help.

“With this assay, we knew that with every test we did we could be saving a life. And it was just that thought - that we could preserve life.

“It’s been the most challenging time in my career, but also the most important and the most rewarding for sure.

“Everyone in the company pulled together, and I now say to myself we have saved lives from March onwards.

“And that makes you feel good.”

Step by step: how test samples are processed at Randox

When a testing kit arrives into Randox, having been used to swab for Covid-19, it goes through a regimented series of steps.

Accessioning, says Jason, is the first of these.

“As this point, the samples are unpacked and put into our system.

“We talk about chain of custody, which is basically when we receive the sample and declare that it is now in our possession, and so we have to know exactly where in the process it is at any given time.

“There can’t be any confusion, and you have to maintain traceability. So that’s the first step - logging it on.

“The next step is putting it through what we call our extraction facility.

“What this process does is remove the RNA and the DNA out of the sample.

“It is then put through to out next link in the chain, which is when we take out our kit that we designed, which contains our reagents and the Covid specific PCR primers; we make up our reagents to carry out the testing and we add the RNA and the DNA from our samples to them.”
Next is PCR amplification, which converts any SARS-CoV-2 RNA in the sample to DNA and uses heating/cooling cycles to multiply this.

Explains Jason: “If you imagine minute amounts of Covid 19 RNA in each sample being undetectable at that stage of the process.

“The process of amplification, which specifically picks out that Covid RNA, will duplicate it and duplicate it to the point where it becomes detectable.

“And after this, the last piece of the puzzle is the detection of the amplified DNA. There are a variety of detection options available, but Randox’s Biochip technology provides a unique capability.

“This is a little ceramic square, which contains little dots, and each one can detect something different.

“So what we do is we put that amplified DNA onto the Biochip, and look for those spots lighting up.

“If two spots light up in the correct position - one for each piece of SARS-CoV-2 specific DNA - then we know that that is positive.

“If we don’t see any of those spots lighting up, then we know it is negative.

“The Randox Biochip has the unique ability to not only test for Covid-19 but also to simultaneously check for multiple other respiratory infections which may have similar symptoms, providing patients with greater reassurance.

“Once the detection stage has been completed, all results are then collated and reviewed. Once authorised the final results are automatically uploaded to be reported electronically.”

Testing is here for some time to come

Jason O’Neill, like the rest of his Randox colleagues, never thought this time last year that professionally, this would be the situation he would be sitting in.

“This is a very unique situation,” he says. “So I’m hoping that 2021 will be a better year for everyone.”

He agreed that the roll out of the vaccine was really positive news.

“Hopefully there’ll be a good uptake of it,” he continues.

“But I think we’ll still be testing for some time to come, maybe not at the same levels, but there are always going to be outbreaks here and there.

“As we look to the future we expect Covid-19 will be added to our seasonal respiratory virus tests.

“So tests will become automatic to see if something is the cold or flu, of it it’s Covid.

“And I think we’ll be busy for some time to come, but I also believe that the next few years will see a return to normal process.”