Life after Covid-19 for the IVD (in vitro diagnostics) industry

The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new opportunity comes new risk.

IVD devices were never big news - until now

Before the pandemic, testing with IVD devices could be complicated and time consuming. The patient experience was often one of waiting and confusion; referrals to hospitals, further appointments, bureaucracy and slow diagnoses. Once samples were sent off to labs, it could take weeks to get results and require a further wait for an appointment to explain them. Patients had no real ownership or control over where and when tests happened, and not much visibility about the meaning of the results.

But it was something we all learned to live with.

EU IVDR (In Vitro Diagnostics Regulation): Time is running out to comply

Covid has changed everything

Now Covid has shown us another way is possible.

As governments managed the global pandemic, it became obvious that rapid testing at scale was the most effective way to contain its spread.

Self-testing with IVD devices was about to ‘save the world’.

As one professor of public health in NYC put it in January 2021:

"As we await mass vaccination, widespread testing offers a real alternative to the dismal choice between lockdowns and deaths. Rapid antigen tests can reduce transmission, reduce the risk of new strains developing, and make us all safer."

UK IVD manufacturers step up

In the UK, IVD manufacturers rallied round to enable cheap and effective home testing solutions for Covid. Rival companies worked with each other and the government to agree on and fast track the development of the technology. They worked together to make testing kits easy to use and as fail safe as possible. In record breaking time ‘lateral flow tests’ were available free of charge for anyone who needed them, and have since become part of our everyday life.

As Stuart Angell, Operations Director and co-founder at IVDeology told us, the speed with which these new products were brought to market was unprecedented:

"In the past, IVDs took 3 - 5 years to launch. Under Covid, companies were asked to approve new testing kits in six months. What we’ve seen in Covid is that a faster moving and more co-operative industry is possible - if we want it enough"

Stuart is hoping that this sense of urgency and co-operation in developing new testing platforms will be extended beyond Covid-19 and the pandemic.

Image: Stuart Angell, CEO and Co-founder of IVDeology

If this joint commitment for faster progress in IVD development and approval can be harnessed, it could help us in the battles against other conditions:

“The same core technology could be used to test for other infectious agents, or in autoantibodies in autoimmune disorders. With all the funding that has been secured for the IVD sector for Covid, can we now focus on cancer, or on motor neurone disease - or fighting anti-microbial resistance? Can we all work together in one direction to make the same kind of progress elsewhere? As a UK industry under the Brexit process now, maybe we have a new opportunity to do that.”

Rapid testing has changed behaviours and expectations

One thing is certain, the experience of rapid Covid testing has increased public understanding about the potential of IVD devices to change the way we manage our health care:

“Diagnostics might once have been an overlooked sector, but not anymore ‘ says Angell . ‘Covid has made IVDs part of our daily routines at home and at work. They’ve shown us people will change their behaviour on the basis of their results. This has made diagnostics a new focus for innovation and investment ”

Add to this a surge in interest in health self-management fuelled by wearables and mobile wellbeing apps, the market seems primed to adopt more IVD solutions in the future.

So, while post-Covid slumps in economies are threatening to suppress technology investment elsewhere, experts are predicting 5% (CAGR) growth in the global IVD device sector through to 2027.

IVD innovation put patients in control

A new generation of IVDs are making diagnoses faster, more accessible and cost effective. And putting more data in the hands of patients is set to improve individual and public health outcomes.

New investment is flooding into companies building on the success of Covid’s lateral flow testing platforms.

These and other IVD companies are finding simpler and less invasive ways of gathering samples and generating results so that biomarkers for cancers and other illnesses can be detected earlier.

More near-patient testing in GP surgeries and simpler self-testing for a broader range of conditions is leading to:

• Better health screening programmes
• Encouragement for reluctant patients to test themselves & act on results (e.g. for STDs)
• More preventive treatment
• Less pressure on hospitals and labs
• Huge potential financial savings for health systems

IVD innovation is also transforming self-management options for diabetics and those living with chronic illnesses. Continuous glucose monitoring (CGM) is helping more diabetics share real time results with their physicians while controlling their own conditions more proactively. This empowerment of patients through data, is reducing health complications, expensive hospitalisations and unnecessary deaths.

And what about other life changing, but non-critical medical services like fertility testing? Male fertility testing kits complete with sperm counting functionality are now on the market, helping couples manage the road to conception from the comfort of their own homes Where once they relied on regular visits to clinics to deposit samples and collect results, it is making difficult medical journeys like these less daunting and costly.

A surging market relies on regulation to maintain standards and reputation

But new interest in the technology is also leading to cheap and inferior quality IVDs being sold over the internet. Meanwhile, some manufacturers are exploiting the grey area between those testing products that currently require regulatory approval and those that don’t.

In this fast moving IVD market place new regulation will be key to developing and maintaining public trust in the solutions that doctors are using, as well as those that can be bought over the counter.

That’s why new regulation like the EU IVDR is including new categories of products in its scope while increasing developers’ responsibility for:

• Clinical evidence
• Quality management systems
• Traceability
• Post market surveillance

What are the IVDR and MDR requirements for Economic Operators

With more patients administering their own tests and interpreting their own results, there is a real need for more oversight and control of products to ensure they can always be used properly and safely.

The future for the IVD sector is exciting and full of opportunity. But existing manufacturers and those developers entering the market for the first time, will need to be adequately equipped for all the shifting competitive and regulatory challenges ahead.