PHOTONICS WEST OPTICAL DIAGNOSTICS


Trust in testing


With huge opportunities for light-based diagnostics and therapeutics to combat disease, successful clinical translation depends on funding robust trials – and greater trust between developers and end-users, finds Jessica Rowbury


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octors’ trust in diagnostic testing has decreased during the pandemic due to exaggerated and inaccurate claims made by


test manufacturers, a panel of doctors said during a Photonics West discussion. Despite the huge potential for optics and photonics technologies to fill gaps within point-of-care diagnostics and therapeutics, trust between manufacturers and medical professionals needs to be re-built, the panel said.


This, in part, will involve rethinking the funding landscape for diagnostic device development, which currently deprioritises large-scale clinical trials, leading to tests that underperform in larger sample sizes. The comments were part of a Covid-19:


perspectives from low-resource settings talk at the Photonics West virtual conference in March.


Mistrust in tests Professor Kev Dhaliwal, consultant physician in respiratory medicine and personal chair of molecular imaging and healthcare at the University of Edinburgh, redirected his research to study the disease progression of Covid-19 when the pandemic hit. His group in Edinburgh investigates disruptive optical technologies to advance respiratory medicine and critical care. ‘We evaluated a whole range of optical diagnostic technologies, from saliva- to blood-based, and found real challenges in terms of performance. ‘We were finding that huge claims were being made about diagnostics,’ he said.


14 Electro Optics April 2021 Omai Garner, director of clinical


microbiology at the UCLA Health System hospital, agreed: ‘There has been a lot of misinformation out there.’ The Health System’s 120-person lab carries out infectious disease diagnosis in Los Angeles. At the start of the pandemic it quickly pivoted to perform real-time PCR testing. ‘Unfortunately, there has been a lot of


poor tests, of which the marketing got exceptionally good media coverage – even globally – and they’ve been widespread for profit,’ he said. ‘[Covid diagnostics] has been an


unfortunately lucrative space – both in the private industry and from a research perspective,’ Garner continued. ‘So, everybody with an idea is getting on board. And because it has been a little less regulated than it should, there have been products that have made it to market, distributed in the US and globally, that have just been garbage tests,’ Garner continued. Clinical decisions are then made on


the results of these tests, Garner added, with both false negative and positive tests potentially leading to increased spread of the virus. The existence of poor tests is a result of not enough robust analysis of the techniques created. ‘A lot of tests have looked really good on a few hundred patients. You take that data and can deploy and roll it out. But then with 1,000 or a few thousand [patients] the test completely falls apart,’ said Garner. This is related to how newly-developed


“You don’t end up making a device, you end up publishing a lot of papers on a new point-of-care technique that has this beautiful sensitivity, then it just ends”


techniques and devices are funded, Garner highlighted. ‘It’s relatively easy to get the funding to


do the research to attempt to create a new diagnostic. But it is incredibly difficult to get funding to do the clinical trials of that diagnostic in an under-served space. I’m going to say it’s almost impossible,’ he said. ‘All of the major funding organisations have this particular issue. ‘The group that wants to fund you to


make the device, is actually a separate group that wants to fund you to prove you can use this device effectively in an under- served area. ‘There is a huge gap in the point-of-care


world, in making something analytically sensitive and making something that’s clinically useful in an under-served area. That gap is poorly studied. You don’t end up making a device, you end up publishing


@electrooptics | www.electrooptics.com


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