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New hand-held device to conduct 12 blood tests and deliver results in 5 minutes

UK-based Attomarker, which enables multiple tests to be performed quickly to know if an infection is bacterial or viral, recently featured, as one of the four teams competing in Longitude Prize, at an exhibition, titled ‘Superbugs: The End of Antibiotics?’ held at the National Science Center in New Delhi.

Longitude Prize – a global competition to accelerate the development of a rapid, accurate, point-of-care diagnostic test to safeguard the future of antibiotics – will select one point-of-care diagnostic test to receive a grand pay-out of £8 million (about Rs 70 crore).

In an interview with India Medical Times, David Miller, Chief Marketing Officer, Attomarker, talks about the innovation, the gap that it aims to fill, the time it will take to hit the market, and the future roadmap.

“A rapid set of tests to profile individuals for allergy, liver function, inflammation, and infections such as sexually transmitted diseases and hepatitis A will be available with Attomarker technology from a prick of blood in five minutes.”

Please tell us briefly about your innovation.

Attomarker has developed a hand-held blood testing technology that can conduct 12 tests simultaneously from a pinprick of blood, with results in five minutes. The device docks onto an iPhone 7 or 8 to provide a user-friendly and accessible interface. The iPhone will be supplied to healthcare professionals but ultimately a consumer will be able to use their own iPhone.

Attomarker will monitor, manage and help combat some of the biggest health challenges of our times. Networked together via The Cloud, Attomarker technology and app-based care pathways will provide governments, health NGOs, healthcare professionals and patients with game-changing solutions in public health. In the developed world, we will help patients avoid the onset of type-2 diabetes and identify and manage their food allergies. Whilst in the developing world, we will map, monitor and combat epidemics of HIV & TB. Together, throughout the whole world, we will join the urgent fight against antimicrobial resistance by helping cut the inappropriate use of antibiotics.

“Attomarker is close to a Series B funding round, which will take the company through the Design for Manufacture, regulatory approval and then mass production.”

What was the objective of doing this, what was the gap that you wished to fill with your innovation?

The healthcare of a growing population requires new technologies both in the hospital and at home. We need to understand patients better biochemically, so we are not all treated as average but as individuals or groups of individuals with similar profiles. In turn, we will be able to stratify treatment resulting in better diagnosis and improved patient outcomes. A rapid set of tests to profile individuals for allergy, liver function, inflammation, and infections such as sexually transmitted diseases and hepatitis A will be available with Attomarker technology from a prick of blood in 5 minutes.

Attomarker ‘s ‘pocket laboratory’ allows biochemical diagnosis to take place when the clinician needs the results. Knowing now means early, accurate intervention to improve patient outcomes. This is the future of healthcare, not just in the doctor’s surgery but also at the bedside in hospital, in the ambulance, in remote communities, in pharmacies and ultimately in the home, projecting the power of diagnosis to wherever it is needed.

How is the current scenario; how will this test make a difference; how will it help disrupt the market?

A recent review has noted that up to 60% of blood tests do not assist in differential diagnosis, in part because they were incorrectly requested, in part because they do not arrive in time to assist with the diagnosis. Point of care testing, such as that provided by Attomarker’s handheld device, offers rapid results with the potential to immediately direct and alter patient care pathways. In a large-scale clinical trial with 10,000 patients, the diagnostic accuracy of GPs detecting pneumonia against the winter flu epidemic rose from 70% to 95%, illustrating how testing in the right setting works.

Attomarker is going to disrupt this market with a pocket-sized point-of-care laboratory which can be used by doctors, nurses and pharmacists, wherever they work, including NGO teams operating in remote locations far from local hospitals. At one sixth of the cost of the current nearest competitor, Attomarker can provide results to the world’s leading healthcare concerns in just 5 minutes.

“The UK NHS is notoriously slow to adopt new technology and requiring GPs to conduct an RTI test to distinguish between viral and bacterial infection is undoubtedly going to cost more than an antibiotic prescription.”

What was the process that you took to develop your product? When did the work start and how much money, manpower has been used to reach the current stage?

Attomarker was founded in 2008 following a series of technical discoveries performed under a £2.5 million EPSRC basic technology research grant won in 2006 to invent multiplexed blood testing technology. These discoveries evolved into the Attomarker’s benchtop device and the core intellectual property. Attomarker was spun out of the University of Exeter in 2008, however the international funding crisis in 2009/10 meant Attomarker was Founder-funded until 2015.

In 2015, a €50,000 Horizon 2020 research grant and a director’s loan allowed the Sony iSight camera (iPhone 6) to image array sensor surface with sufficient sensitivity to perform our C- reactive protein (CRP) biomarker assay. Following this, a £500,000 Seed funding in 2017 from the British Innovation Fund (BIF) was used to demonstrate Attomarker’s milestone 1, the handheld device Proof-of-principle in just 99 days. Subsequent Series A funding from the British Innovation Fund of £2.5 million in 2017 was used to demonstrate the performance of a CRP assay, aligned with FDA requirements for accuracy, precision and limits of detection.

Attomarker has developed a distributed business model keeping the core activities in the company to just four employees and engaging with industry leaders in the development of the technologies. In total, more than 50 engineers and scientists have worked on the project through the development phases and these will then form part of a production consortium. Currently technology is paused at the M2 milestone, however is poised ready for scale-up, CE marking and FDA approval.

How long will it take to hit the market, at what stage is this development?

The Attomarker M2 handheld device has no US predicates and requires a De Novo FDA validation route to market. All of the quality control parameters have been identified and specified for production and small-scale laboratory production to meet FDA requirements was successful. The expectation is to improve performance in a fully QC-controlled automated production. Attomarker is close to a Series B funding round, which will take the company through the Design for Manufacture, regulatory approval and then mass production.

“Attomarker is working on a Liver Function Test Chip partnered with a phone app with the vision to facilitate at home liver function testing and personalised care pathways to accommodate effective behavioural changes that improve liver health.”

How big is the target segment for this product?

The size of the market opportunity in the UK is expected to scale with population in the high-income countries of the EU and the US. The total launch market is approximately £2 billion dominated by the cohort selection and surveillance opportunities followed by antimicrobial resistance stewardship.

This encompasses addressing the Four Global Health Challenges such as Antimicrobial Resistance, Early onset Type-2 Diabetes, epidemics such as HIV and TB, in addition to allergy. An estimated 31 million antibiotics are prescribed each year in the UK. Attomarker could be deployed to all 39,000 GPs (General Practitioners) in the UK as part of an antimicrobial resistance stewardship effort to reduce unnecessary antibiotic prescription by facilitating the differential diagnosis of bacterial and viral infections.

What is your marketing plan? How do you plan to reach doctors, laboratories and hospitals?

Our marketing plan will target pharmacies as well as doctors; care homes as well as hospitals. The UK NHS is notoriously slow to adopt new technology and requiring GPs to conduct an RTI test to distinguish between viral and bacterial infection is undoubtedly going to cost more than an antibiotic prescription.

We therefore expect to make slow progress in changing attitudes in this area. Our short-term focus will be on launching a range of tests into UK pharmacies, giving them the ability to offer their customers a number of blood tests, from C-Reactive protein to Fatty Liver to Food Allergy. We will also be marketing to private doctors in the UK. In addition, we will be marketing to cruise ship owners, care homes, the military and airlines – all of which have a duty of care role to play. Once launched in the UK, our plan is to identify distributors in mainland Europe, North America and Asia.

Once ready for actual use, how much the test would cost?

Our goal once high-volume production has been established is that the standard CRP/AMR test should cost less than £10 to deliver.

“Raising funding for a medical device in London is notoriously difficult. Nearly all VCs avoid this opportunity because it’s expensive, takes time because of the regulatory pathway and even when regulated, clinical adoption remains a risk.”

If you win, how will you use the money?

Winning the Longitude prize would facilitate Attomarker to accelerate other test chips in our pipeline. For instance, the prize fund would be invaluable in our efforts to tackle Acute Undifferentiated Febrile Infections (AUFI) Chip in remote communities within low-income countries.

AUFI causes are numerous and are the most preventable deaths in such regions. Prevention of severe illness depends on early detections and diagnosis. However for most patients in developing countries access to such medical services is difficult. An Attomarker AUFI chip would provide life-saving diagnosis for AUFI in even the most remote communities, significantly improving public health and infectious disease management in low-income countries.

What’s the future roadmap for your innovation?

Attomarker’s CRP test is the first of a number of tests that the device itself can deliver. Our road map will comprise an early launch of CRP, followed in quick succession by Liver and Food Allergy, then one to two new tests annually.

As a company, what else are you working on?

Attomarker’s future test portfolio is estimated to have a market size in excess of $50 billion. An example of a future test in Attomarker’s pipeline is the Liver Chip. The liver is responsible for over 500 essential bodily reactions establishing itself as arguably one of the most complex organ. Liver disease is the fifth largest cause of death, with Pamela Healy, CEO of the British Liver Trust, stating one in three people are at risk of getting liver disease. It is a silent killer and people often don’t realise they have a problem until it is too late.

However, 9 in 10 liver diseases are preventable with lifestyle changes, demonstrating the importance of liver health monitoring. The number of people affected by liver disease continues to rise, making it one of the most significant health issues in the UK. Attomarker is working on a Liver Function Test Chip partnered with a phone app with the vision to facilitate at home liver function testing and personalised care pathways to accommodate effective behavioural changes that improve liver health.

How has been your experience of developing this product? How is the current ecosystem for bringing breakthroughs in healthcare? How do you think the ecosystem could be made better for healthcare innovators?

Raising funding for a medical device in London is notoriously difficult. Nearly all VCs avoid this opportunity because it’s expensive, takes time because of the regulatory pathway and even when regulated, clinical adoption remains a risk. The NHS in the UK is an excellent organisation in which to trial new technologies but is notoriously a graveyard for SME companies. Adoption has changed as a result of new initiatives in the NHS and these are making progress.

UK companies also need to look outside the UK to the EU and US for larger markets with different entry risk and of course different regulatory requirements. Health innovators have a long regulatory pathway and even longer to clinical adoption – but this is right and proper – the device could become integrated in a care pathway and so must perform reliably, precisely and accurately. This should not change but maybe investors could be incentivised to mitigate the risk profile.

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