LumiraDx: Fighting antimicrobial resistance with innovative POC testing

Antimicrobial resistance (AMR) is ever-evolving and perhaps the most dangerous global health threat of modern times, an issue that will require cutting-edge innovation to resolve. LumiraDx, pioneers of medical diagnostics, explain how their revolutionary point of care (POC) platform can alleviate the dangers of this rapidly exacerbating problem.

The recent GRAM report comprehensively illustrated the grim landscape of antimicrobial resistance around the world, signifying the immense magnitude of what may potentially be the most considerable health crisis of the 21st century. The report outlined that in 2019, 1.27 million deaths were attributable to AMR, with a staggering further 4.95 million deaths associated with antimicrobial resistance1. To put this into perspective, HIV and AIDS, two of the most significant contributors to global mortality, caused 860,000 and 640,000 deaths, respectively. Previous estimates forecasted that by 2050, AMR would cause 10 million deaths annually; it seems that we may reach that number far sooner than expected. Technological medical advancements, such as point of care testing, have the potential to reduce this burden.

Through a new assay available on their next-generation point of care Platform, LumiraDx is aiming to help mitigate the threat of AMR and ensure that these harrowing estimates never come to fruition. Founded in 2014, LumiraDx set out on an endeavour to become a global leader in medical diagnostics, developing point of care testing technologies that are affordable and available worldwide. The company’s point of care testing platform supports a growing number of tests and can expertly distinguish a range of infections in mere minutes, enabling healthcare professionals to make informed, rapid treatment decisions, including where to prescribe antibiotics, ultimately helping to reduce AMR. Health Europa’s Digital Editor, Jack Thomas, spoke to Dr Jayne Ellis, the Head of Medical and Clinical Affairs at LumiraDx, and Professor Jonathan Cooke from the Department of Surgery and Cancer, Faculty of Medicine at Imperial College London, to explore the threat of AMR and how the company’s technology looks to combat it.

Please can you explain the current landscape of antimicrobial resistance, is it increasing, and what are the key drivers?

Professor Cooke: If you look at the history, AMR started from when the first antimicrobial was used in the early 20th century, and certainly, when microorganisms are challenged by antimicrobial agents, many of them develop systems to bypass the effects of these agents, and this is simple evolution.

We know that there is a direct relationship between antimicrobial use and the development of resistance, and the more you use, the higher AMR will be. So inappropriate clinical prescribing and indiscriminate farming use promote this and drive AMR.

Now, if we look at the WHO Global Action Plan objectives, there are five aimed at improving awareness and understanding of antimicrobial resistance. These are: improving effective communication, education, and training; strengthening the knowledge and evidence base through surveillance and research; reducing the incidence of infection through effective sanitation, hygiene, and infection prevention methods; optimising the use of antimicrobial medicines and human health; and finally, developing the economic case for sustainable investment. That takes account of all countries’ needs and increases investment in new medicines, diagnostic tools, vaccines, and other interventions. That is the landscape within which we face the problem. Indeed, over the years, antimicrobial resistance, which is the resistance to bacteria, fungi and viruses, has increased progressively.

Would you agree that AMR is potentially more concerning than COVID moving forward? And if so, why?

Professor Cooke: Currently, COVID-19 deaths are around 5.5 million, so there is potential that AMR will surpass this. Furthermore, AMR includes resistance in bacteria and fungi as well as viruses. Up to 50% of pathogens causing surgical site infections and over a quarter of the pathogens causing infections after chemotherapy are already resistant to standard prophylactic antibiotics in the USA. COVID-19 itself could be argued as being a prime example of antimicrobial resistance because the virus has emerged with minimal susceptibility to existing antiviral agents.

The economics of AMR is terrifying, with estimates suggesting that a continued rise in resistance by 2050 would lead to 10 million people dying every year and a reduction of 2% to 3.5% in gross domestic product. This would cost the world up to $100 trillion every year.

The over-prescription of antibiotics is a primary driver of AMR. Are respiratory diseases an area where this overuse is most frequent?

Professor Cooke: In all health economies, most patients present problems with respiratory tract infections to their GPs; these conditions account for at least 50% of general practitioners’ prescribing of all antibiotics. We know that most of those respiratory tract infections are viral and are not susceptible to antibiotics. Therefore, the doctors are prescribing agents that are not only useless but potentially dangerous, as they have a number of side effects.

Can increasing the adoption of point of care testing help alleviate this problem?

Professor Cooke: Yes, point of care testing is one of the tools we can use to improve therapeutic clinical decision making, face to face with patients who are presenting with symptoms of respiratory tract infections. We did a study in the Northwest of England that showed that, in patients who presented with symptoms of respiratory tract infections and who would have received an antibiotic prescription, 63% had a C-reactive protein (CRP) blood level of less than 5 mg/l, which meant that they did not need a prescription. That puts it into perspective.

We also did a major review of all the evidence around the use of CRP testing, incorporating thousands of patients and dozens and dozens of clinical trials. An overwhelming number of studies demonstrated that the use of CRP tests for point of care patients presenting with respiratory tract infections reduced index antibacterial prescribing. Furthermore, GPs and patients report very good acceptability for CRP point of care. 2

In a recent pivotal study in the New England Journal of Medicine, patients with acute exacerbations of COPD who were undertaking CRP point of care testing resulted in a lower percentage (48% versus 70%) of reported antibiotic use and prescriptions received from clinicians. There was also no evidence of any harm as a consequence. More than 80% of these patients receive antibiotic prescriptions in the United States and Europe. 3

LumiraDx was created with the vision of making point of care diagnostics affordable and available. Please, can you give me an overview of your testing platform and where can the product be used?

Dr Ellis: The LumiraDx Platform is a small, innovative point of care diagnostic system designed to support a broad range of tests. The benefit of this is that you can run many tests on the same system but get lab comparable results at a low cost, with results available in minutes and near the patient. The Platform achieves this by using unique microfluidic technology. The research and development team were able to take the basic principles used in laboratory analysers and condense them all down into the small instrument but still give you the speed and performance that you need to have accurate information available quickly.

It is intuitively designed and has a touchscreen located on the front, making it very easy for healthcare professionals to use; they do not have to be trained laboratory experts to utilise the technology. Another benefit is that the workflow stays the same as new tests are added to the Platform, meaning that if you have been trained on one, you can very quickly pick up how to run the next test, etc. This helps save precious time training staff.

The Platform can be used wherever the patient is based; for example, that could be in a hospital, a medical office, or a pharmacy. But it has also been used in non-traditional settings, like schools, workplaces, and airports. Because the technology is very portable, you can take it wherever the patients are. It also has connectivity, which is essential. In the modern world, we need to quickly get the data from the instrument and into the patient’s health record. The Platform has all of those functions built in to achieve that.

The company has recently achieved a CE Mark for its C-reactive protein test. Could you share more on how and why the test is used? How long does it take, and where can it be used?

Dr Ellis: The CRP test is the newest on the Platform. It is quantitative, providing the result on the screen as in milligrammes per litre. It can use finger stick blood, where you take a finger stick sample from a patient, but can also use venous blood or plasma and gives you the results in just four minutes, which is very quick, and it can be used in point of care settings.

CRP is often used in primary care to help assess people presenting with a suspected respiratory infection, such as a lower respiratory tract infection, which viruses or bacteria can cause. Sometimes those infections are self-limiting, meaning that they can resolve themselves; sometimes, they require treatment.

Because the causes of infection are broad, you don’t always require an antibiotic, and the antibiotic won’t work if it is given for a viral infection. The CRP test can be used at the patient side to help assess if the patient needs an antibiotic alongside their clinical symptoms. If the result of CRP is very low, it indicates that you probably don’t need to give the patient antibiotics. Physicians have told us that it is reassuring for the patients who sometimes are worried that they will need them. Also, it means avoiding giving antibiotics incorrectly to people who don’t need them, so it is extremely important in the prevention of AMR.

The CRP test can also be used in secondary care; for example, a physician may want to quickly know the CRP level of a patient because of a suspected infection. The physician may be looking for very high levels of CRP, which is a red flag and indicates a potentially serious infection.

How important is the portability of the test, and what is the impact of that?

Dr Ellis: The portability is essential. It means flexibility of use in primary care. Patients can be tested in the clinic, but also nurses can easily transport the Platform in their car and go to patients’ homes. An example of this is COPD, where patients are sometimes housebound and require assessment for antibiotics when they have emerging acute exacerbations.

Our Platform enables nurses to go into a home, quickly test them, and help make a better decision about whether or not they need to take an antibiotic. Another example is care homes. The Platform can be taken to a care home when a doctor or nurse visits to assess patients, providing them immediate, rapid results.

The company has also achieved a CE Mark for its SARS-CoV-2 and flu diagnostics. Can you share why this is also an important test for the company?    

Dr Ellis: There has been the emergence of new COVID-19 variants recently, and the rates of infection have risen all over Europe. Additionally, we have started to see influenza activity appearing as well. Having a test like ours is important because it can do three tests in one. It can test for SARS-CoV-2 and Flu A and Flu B on the same sample. You just take one sample from a patient, put it on the test, and it gives you three results.

This is really useful because if someone tests SARS-CoV-2 negative, then there is a worry it might be flu. Our test means that they can quickly identify if it is flu and then if it is Flu A or Flu B because that is also a crucial piece of information.

This is essential because when people present respiratory symptoms, the symptoms overlap, meaning it is not easy to know what the underlying infection is. Knowing this information helps the physician determine appropriate clinical choices to get better patient outcomes and better patient workflow.

Future developments

LumiraDx products are currently operating in 98 countries, and the company has a vast array of launches planned for 2022, including tests for RSV + COVID-19 and Strep A.

References

  1. Murray CJL, Ikuta KS, Sharara F, et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet 2022.

2: Cooke J, Llor C, Hopstaken R, et al. Respiratory tract infections (RTIs) in primary care: narrative review of C reactive protein (CRP) point-of-care testing (POCT) and antibacterial use in patients who present with symptoms of RTI. BMJ 2020

3: Butler C ,  Gillespie D, White P, et al. C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations. NEJM 2019

Special Report Contact Details
Contact: Jayne Ellis, LumiraDx & Professor Jonathan Cooke, Imperial College London
Organisation: LumiraDx
Email: jayne.ellis@lumiradx.com
Email: j.cooke@imperial.ac.uk
Website: Visit Website

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