Diagnostics in the time of COVID-19 – and beyond

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Adrian Smith, UK general manager, Hologic, explores how the UK diagnostics sector and existing screening technology, for conditions such as STIs and cancer, has been adapted to meet COVID testing demands.

Driving scale and capacity for COVID-19 testing

At the beginning of the COVID-19 crisis, we recognised that Hologic could play an important role in helping to meet this challenge, by leveraging our existing, nationwide network of Panther systems. These robotic platforms are fully automated, high-throughput molecular diagnostic testing machines, which process Hologic’s Aptima SARS-CoV-2 assay, a highly accurate COVID-19 test that can be manufactured at high-volume in the UK.

More than 100 Panther systems are already installed in over 50 labs across the UK and widely used for existing national screening programmes, such as cervical cancer and sexually transmitted infections.

This fleet can process over 100,000 tests a day across various diseases including COVID-19. This ensures that large volumes of Coronavirus test results are delivered quickly, allowing people to either get back to work or self-isolate. This continues to be a crucial element of mitigating the health, economic and social harm caused by the pandemic.

The system’s sophisticated automation means COVID-19 tests can run simultaneously with those for sexually transmitted infections, cervical health and virology. This will be vital in maintaining ongoing cervical health screening and testing programmes, while responding to possible future waves of COVID-19.

We have also rapidly expanded our European manufacturing facilities in Manchester to significantly increase production capacity, investing over £6 million and creating 44 new highly skilled jobs in the city. This enables us to produce COVID-19 tests at this site, which along with having distribution based in the UK, creates a more robust, resilient supply chain for the assay, which is better insulated from global supply challenges. We continue to work with partners to strengthen the supply of ancillary parts of the testing process, beyond our immediate supply chain.

Delivering at speed

In ‘normal’ circumstances, developing an assay can take several months, or even years. However, we developed our Aptima SARS-CoV-2 assay in just 90 days. Prior to this, accredited medical laboratories that use the Open Access functionality on the Panther Fusion system were able to create their own laboratory developed COVID-19 tests within 30 days to run on this fully automated, high-throughput platform.

The unique challenges COVID-19 has created have also been a catalyst for positive change, as it has compelled the sector and NHS to search for new technology and solutions, as well as accelerating decision making. We’re proud of the way Hologic has adapted to the new environment and worked creatively to tackle the ongoing crisis.

Pushing innovation in the diagnostic sector

Beyond the immediate challenge of COVID-19, the UK must now consider what other steps should be taken to ensure it has a resilient and flexible diagnostics sector that can respond to future pandemics or other diseases with speed and efficiency.

Embracing new technologies and innovation will be crucial, whether this means welcoming smaller companies who have traditionally found it harder to enter the UK market or challenging ourselves to find new solutions. Flexibility and forward-thinking must become the hallmarks of the diagnostics sector, with all innovation being underpinned by a solid evidence base.

The pandemic has also changed how and where people are working as well as how they are accessing healthcare. Virtual consultations, once viewed with scepticism, are now an essential part of primary healthcare. The same principles apply to the diagnostic sector, with techniques such as digital cytology that allow results to be interpreted outside of a clinical setting or remote imaging for breast cancer, which make it more convenient for patients to take up offers of screening. It’s crucial that we harness this change of mindset and encourage wider uptake of these techniques.

By embracing new technologies, screening programmes can also become more efficient by allocating human resource where it is most needed. For example, radiologists will be able to use AI to identify images where there is most likely to be an issue. With cervical screening, using a mRNA based test can negate the need for a colposcopy due to its increased specificity. Colposcopies require considerable resource, not to mention potential worry and discomfort for the woman.   

Looking ahead

We are certainly not in the clear when it comes to COVID-19, and we know that we will face more challenges, particularly as we approach the flu season. We must build a diagnostics sector that can respond to the obstacles thrown its way, harnessing innovations that already exist, and creating an environment in which pioneering diagnostic companies can provide new ways of solving old problems.

We also have a role to play when it comes to emphasising the importance of screening and testing programmes to the general public, whether it’s encouraging women to attend cervical screening appointments as uptake has dipped in recent years, or letting women know it’s safe to get a mammogram. As more reports emerge, we realise the pandemic has had a wide-ranging impact on health – the sooner we can get screening programmes back to full capacity, the better patient outcomes will be as it will allow quicker treatment if required.

Hologic stands ready to work with health officials, clinicians and laboratories in the months and years ahead to ensure the best possible patient outcomes. How we have responded as a company over the last six months shows that we are more than up for the challenge.

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