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Company of the Month – iFAST

iFAST may currently have a small team, but they are tackling a huge issue. Antimicrobial resistance (AMR) – also known as antibiotic resistance – has been named as an ‘emerging crisis’ by the United Nations, and ‘one of the biggest threats to global health, food security, and development’ by the World Health Organisation (WHO).

iFAST is helping manage this growing issue, through the invention of a ground-breaking new process for Antimicrobial Susceptibility Testing (AST), that vastly cuts down the time it takes to test a patient’s resistance to an antibiotic, and thus, the time taken to choose the best treatment. We spoke to CEO, Dr Toby King, this month.

Antimicrobial resistance

Alarm bells have been ringing on AMR for a number of years. The latest discovery of a new class of antibiotics to reach the market was back in 1987, and today there are very few novel antibiotic classes in the drug pipeline.

A growing number of infections – some that have been easily treated and kept under control for the last century, including pneumonia, tuberculosis, gonorrhoea, and salmonellosis – are becoming harder and harder to treat. As bacteria have adapted to the antibiotics we’ve used for decades, those treatments are becoming less effective.

Worldwide, over 1 million yearly deaths have been directly attributed to AMR. Worryingly, a widely cited estimate is that by 2050, this could increase to 10 million yearly deaths, making AMR deadlier than cancer.

The beginnings of iFAST

The genesis for iFAST came when Dr Daniel Spencer began his PhD in the lab of Prof Hywel Morgan at Southampton University. Together, they investigated techniques for the electrical characterisation of individual cells at high speed. During the course of the research, they realised that they could use the same technique to rapidly determine whether bacteria had been affected by antibiotics. They patented the technology, and iFAST emerged as a spinout in April this year.

Although the two inventors are maintaining active leadership roles in the company (Daniel as VP of Engineering and Prof Morgan as CTO), they took the early decision to bring in Prof Mark Sutton – a leading expert in microbial resistance with the UK Health Security Agency (UKHSA) – as CSO, as well as an experienced leader as CEO to help build the company. Dr Toby King has a long history in medical companies, after a somewhat early start to his career, as he explains:

“I founded a medical electronics company at 16, when I was still at school. I’d always been interested in engineering, but everyone in my family is medical, so biomedical engineering seemed a natural fit.”

Following this early start, Toby went on to study engineering at Cambridge, and completed his PhD there, looking at how to improve the processes used for designing medical devices. Since then, he’s spent his career in technology consultancy, mostly in medtech startups, including a spell in Silicon Valley. For the last five years, he’s been advising spinouts from Southampton University, Imperial College and others.

In short, Toby is well-placed to help guide business and product development, while the rest of the founding team bring huge technical experience.

iFAST technology

The iFAST team see the potential for their technology to have an explosive impact on the $4billion AST market. With bacteria resistance levels at anywhere between 20-98% (depending on location and the bacteria being looked at), testing patients for resistance before choosing which drug to use is becoming increasingly important.

The current gold standard for AST involves taking a sample from the patient, culturing to grow colonies of the bacteria, and testing against different drugs. In all, the process takes 48-72 hours. Meanwhile, the patient will be receiving treatment that they may well subsequently be found to be resistant to.

The patented process the iFAST test uses shortcuts the need to culture colonies of bacteria. It accurately measures the response of a small number of bacteria, reducing the time taken for testing to just four hours. As Toby explains, this time saving could have a drastic effect on patient outcome:

“There are some studies that indicate that every hour of delay for a sepsis patient increases their chance of mortality by 5%. So, for that patient, saving over 40 hours of waiting for the right treatment would be ‘life or death’. Less fatal, but very common, infections like urinary tract infections (UTIs) and MRSA, often lead to other infections, as well as adding to the growth of antibiotic resistance in the population when they’re treated with the wrong drug. In most cases, clinicians will be able to wait just four hours for the AST result, meaning the patient won’t be prescribed an initial course of the wrong antibiotic, and will receive the right treatment much faster.”

The team worked with UKHSA to test their process and the work, carried out at Southampton University, displayed over 99% agreement, against the current gold standard of AST testing.

Wider uses

As well as the infections already mentioned, the process iFAST uses could be applied to any type of bacteria. In healthcare, this would include sexually transmitted infections, tuberculosis, and more. Beyond that, the team are already exploring veterinary applications, and see potential for its use in food safety and agriculture.

For now, the primary focus is on productisation of the technology for healthcare, with a target of late 2023 for the product to be available to research labs, and 2024 to be available for clinical settings.

Funding

To fund this roadmap, iFAST is currently raising investment in a seed funding round. They’re near to closing this £1.5 million round, which they hope will be led by Qantx, a relatively new fund looking to promote early stage businesses in the South West.
As part of this drive, MedCity also facilitated introductions to KHP Ventures, who are also keen to invest after iFAST took part in a MedCity Investment Hub pitching event earlier this year.

Toby has his sights set on a Series A funding round in late 2024, to support their worldwide roll-out of the product once it is approved. In the meantime, he’s relying on his extensive experience to keep development on track on a tight budget:

“If you’ve only got £1 million, you can’t run five projects simultaneously. It’s really, really important to keep the company laser-focused. Understanding things like what you need to do in-house, what you need to subcontract and how the regulatory and quality processes work… I think those are the really key things. I suppose that understanding, which comes from experience of having taken multiple products to the market, is part of what I hope I bring.”

Commercialisation of research

Toby also credits the inventors with already having done much of the hard work to ensure a successful spin out:

“Hywel Morgan brings incredible experience of the technology and really knows the field inside out. Often, you come across great pieces of technology coming out of universities, but they don’t have a viable application in mind, they’re very expensive and they don’t have a clear value proposition. By contrast, Hywel really had those in mind from the beginning.”

With that value proposition in mind, the team are confident that their product will be well within the reach of NHS hospital microbiology labs:

“It will be a circa £20k piece of equipment, and around £5 per test. This is, in most cases, cheaper than current processes. It’s so cost effective because the process uses very little in terms of materials like reagents and antibiotics, and it’s so quick and automated that labour costs are low. There’s also a very high throughput – we can measure 10,000 bacteria a minute, testing 100 patient samples a day per machine.

Even competitors working on new solutions in this space can only test a handful a day, take 24 to 30 hours, and are much more expensive. This gives us a big edge, commercially.”

Also key to the commercialisation of the technology has been support from SETsquared – a business incubation network run by six universities in Southern England – and a partnership with Southampton General Hospital. The partnership with Southampton General has been crucial in allowing the team to test their process using real patient samples, alongside the current lab processes. Toby is excited for the value this partnership will bring to the next stage – as they perfect the workflows and processes involved in using their product in a hospital. To this end, they’re also developing partnerships with a number of London-based hospitals, as well as in other parts of the country. As Toby says:

“The more of those relationships we can build, the better, because you don’t want to design a product that only fits into the clinical workflow in one lab. You want something that works in every lab.”

A $billion vision

Toby is clear that it’s early days yet for iFAST, but says that, in all of the work he’s done with startups, this technology has the most exciting potential he’s seen for a long time:

“My vision is to build a business of real scale – a billion dollar business. I think the world needs this technology really, really badly, and I see no reason why we couldn’t have a really successful British diagnostics business, in an area that is one of the World Health Organization’s top 10 key priorities.”

Find out more: ifastdiagnostics.com

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