The life sciences company is increasing inventory, and is also expanding facilities such as a new lab in Dassel in Germany with an additional service lab set to go live in China in 2021. The new Cytiva diagnostic services on offer will include training, test optimization expertise and contract development.
Those projects form part of the spend the life sciences company announced in September, with it allocating US$500m to realize its goal of raising overall manufacturing capabilities within five years.
We caught up with Emmanuel Abate, vice president, genomics and cellular research at Cytiva, to get his views on continued challenges linked to COVID-19 testing and the role the company has played in helping the diagnostic industry navigate the pandemic via its manufacturing and design expertise.
“One of the key things that still needs to be resolved is easy access to diagnostic tests for a large part of the population. Even before we get to the point where we have COVID-19 vaccines and therapies, diagnostic [testing] is what is going to help us to get back to as normal a life as possible. So we have been very busy supporting our diagnostic customers over the past six to nine months.”
Such collaborative efforts have included Cytiva’s work with genedrive, a molecular diagnostics business; the partners’ delivered ‘innovative’ PCR COVID-19 testing kits based on Cytiva's 'Ready-to-Go' formulations. The past few months have also seen Cytiva support Avacta in the development of its rapid antigen test strip to detect the SARS-COV-2 spike protein.
First COVID-19 wave
As the COVID-19 pandemic took off globally, the industry came together to develop the first kits, sharing a lot of information. “It was quite impressive,” remarked Abate.
Then the challenge came as to how to scale that up and make the kits available broadly – the industry faced huge hurdles such as access to raw components, and in developing capacity to move from zero to the millions of tests that were expected; there were also challenges associated with deploying those, in terms of having enough trained personnel and infrastructure.
Some countries, inevitably, responded better than others, noted Abate.
And in the acute phase of the crisis, from April to June, the idea of accelerating in-country diagnostic kit manufacturing was proposed as the solution. But Abate believes such proposals were driven by extreme panic.
“I don’t believe that more local or in-country manufacturing is truly needed. The call for such is more politically driven, policymakers talking about protecting their populations by bringing it back home, than by any lack of manufacturing capacity.
“Industry is past the crisis phase; we have more visibility on the number of tests that are required. In the case of Cytiva, we have significantly increased our manufacturing capacity, we have spent a lot of money ramping up our labs, and so have our suppliers, our competitors and our partners. Capacity is getting there.”
'A broad network of smaller, innovative diagnostic firms is emerging'
The US has always invested a lot in the diagnostic market but so has Western Europe.
“In the past six months, China has been extremely active. They rushed to develop their tests and we see a lot of demand in Southeast Asia for components. However, globally, we are now seeing a lot of smaller firms – biotech companies and innovators - coming with their kits and asking for help. To that extent, apart from capacity for components, we decided to invest in service labs so that we can partner with those diagnostic companies.
"While we have been doing that work for many years, it has mostly been in one location; now we are expanding to Germany and duplicating our European model in Asia; in that way, we can get closer to our Asian customers.”
Accelerating test turnaround time
Effective testing strategies rely on a portfolio of test types that can be used in different settings and situation, said the World Health Organization (WHO) in September.
But the majority of COVID-19 testing happening today still tends to rely on polymerase chain reaction (PCR) technology. These tests detect disease by looking for traces of the virus’ genetic material on a sample most often collected via a nose or throat swab.
In terms of the speeding up the turnaround time for COVID-19 tests, Abate said there is work underway to see how to push out more tests with this existing PCR based infrastructure. “What Cytiva is doing in this respect is improving the PCR workflow, that is one way to improve speed, so lab work that would normally take up to 60 or 90 minutes now can be done in 10 or 20 minutes by simplifying all the steps involved.”
More rapid testing models are being approved and slowing rolled out but the major driver of diagnostics, moving into the future, is bringing the test closer to the patient.
The ideal COVID-19 diagnosis test would be a pregnancy style test kit, relying on saliva, said Abate. “A lot of companies are working on this model. It is too early to say whether it will be feasible. Cytiva is working with a kit developer to try and get there.”
Testing alone, of course, is not sufficient for controlling the pandemic. “It is testing, tracing and isolating. The number of tests per week in France right now has never been as high but it is still out of control as we are struggling to isolate.
“Testing also has to be as broadly distributed, as cheap and as easy to do as possible because the key challenge in relation to the COVID-19 is the number of asymptomatic cases, a lot of people will never develop symptoms or by the time a person develops symptoms they are already contagious.
“Testing plays a fundamental role in bringing us back to a caseload level that we can effectively deal with. And I believe that COVID-19 testing is here to stay; population monitoring tools will still be key, even when vaccines and therapies are available.”