Speedy testing for STIs - revolutionising point-of-care treatment

6 April 2017

Sexually transmitted infections (STIs) take a day to diagnose in the lab, and patients aren’t often keen to hear their results. Dr John Clarkson believes he can cut that time down to half an hour. Greg Noone talks to the CEO of medical start-up Atlas Genetics about how its new diagnostics platform promises to revolutionise point-of-care treatment for STIs and influence social conventions along the way.

Chlamydia is the cuckoo of sexually transmitted diseases. The bacterium is a form of obligate intracellular parasite, meaning that it requires a host cell as a source of nutrients and a source of shelter in order to breed. Under the microscope, it is frequently visualised in false colour as a collection of spores – which, despite sharing some behaviours, it is not – nestling under the flimsy, half-smashed carapace of a much larger cell. It is the most common STI found in human beings. In many cases, the presence of the infection is completely asymptomatic, but signs can include pain during urination, reactive arthritis, pelvic inflammatory disease, infertility and unpleasant discharges from the urethra, vagina or rectum.

Despite this catalogue of horrors, chlamydia is eminently treatable: with a short course of antibiotics, it can be wiped out in a matter of weeks. The fact remains, however, that an alarming number of patients who submit samples for examination do not return to hear their results. According to Dr John Clarkson, CEO of medical start-up Atlas Genetics, it’s symptomatic of long-standing – and somewhat Victorian – attitudes towards genital infections among many people, and a waste of everybody’s time.

Tackling the turnaround

“From a clinical need perspective, this is an area where doctors want tools that they can use to diagnose and treat patients on an immediate basis, rather than the current turnaround time of four to ten days,” he says. Moreover, “most people anticipate one or two weeks to get their test results back, and that’s not good. If the patient’s got an STI, they really want to know quickly and be put on the right treatment.”

It is for these reasons that Atlas Genetics, after collaborating with US-based diagnostics business Osmetech and researchers from the University of Bath, has developed the io System, a platform capable of detecting the presence of chlamydia in multiple raw sample types in under half an hour. In January, the firm announced positive results from a beta study of the platform’s ability to rapidly diagnose chlamydia; the following month, it managed to raise around $35 million in Series D funding. Clarkson hopes that the io System’s eventual roll-out to medical facilities across Europe and North America will transform point-of-care treatment of STIs.

"We run the whole process, from the insertion of the sample to the test result for chlamydia or gonorrhoea, in a 30-minute time frame."

“The clue is in the name,” he says. “Infectious diseases are contagious, and they’re not only bad for the individual, but also for the community. So it doesn’t really make sense to do things the way we do it now.”

Hidden figures

Clarkson is a creature of process. Although possessed of a background in molecular biology, he is more interested in the sequence of events that takes place in infectious-disease diagnostics than research into individual bacteria and ways to shorten it. By taking routine diagnostics out of the laboratory and dropping it into the GP’s office, Clarkson hopes that a vast amount of time and effort can be cut out of testing for STIs. The question raised was how to achieve this on a technical basis. The answer, after many years of intensive research and development, resembles a household printer.

Equipped with a small screen and clad in white and coloured plastic, the io System looks deceptively simple to use, as if the designer was instructed to make the DNA sequencing of complex bacteriological specimens suitable for ages three and up. The magic happens behind a small hinged flap towards the base of the machine. Here, a cartridge containing the raw clinical sample and all the technology used to analyse it is inserted into the io System like a VHS tape and then left to quietly brew.

“The cartridges are really where most of the novel technology is being put,” says Clarkson. “They have the capability to process the clinical samples, to get the pathogen DNA out of that sample in a purified form. Then the target is amplified. We use a very well-known system called PCR amplification: it amplifies copies of the DNA to a detectable level. Then we use an electronic sensor – sort of a novel sensor approach – within the cartridge and the instrument to detect the presence of that target DNA. We run the whole process, from the insertion of the sample to the test result for chlamydia or gonorrhoea, in a 30-minute time frame.”

For Clarkson, it’s the kind of platform that can be deployed with ease in any STI clinic. The io System is also predicted to substantially reduce the inclination of clinicians to prescribe powerful antibiotics in the interval between the presentation of symptoms by the patient and the collection of results, thereby reducing the risk of antibiotic resistance. Additionally, the platform is designed to help bridge the gap between a rising number of STI cases and a palpable lack of dedicated clinicians operating in this area.

“Hospitals are finding it increasingly difficult to get trained technologists in microbiology,” explains Clarkson. “The simplicity of operation means quite a few of these instruments, we believe, will end up in some of the smaller hospitals – ones that may have less capability but nevertheless want to carry out very rapid diagnoses. We think that’s an opportunity.”

Further applications

The platform derives from specific choices made by Atlas Genetics on what infections the io System should be used to diagnose. Clarkson acknowledges that the technology inside the io System could theoretically be used to test for a range of other bacteriological infections, and this is something he and his colleagues prognosticated over for a long time.

In 2005, the Daily Mail connected the firm’s research with a new test for meningitis. A bacterial infection that afflicts the meninges of the brain, the disease is not only fast-acting, but also presents a vague triad of symptoms – vomiting, rashes, a stiff neck – that can sometimes mislead doctors into making an a fatal misdiagnosis. That Atlas Genetics chose to shift its research towards STIs instead was partly down to an assessment of supply and demand.

“The comparison between meningitis and STIs is quite interesting,” explains Clarkson. “Fortunately, the number of cases of meningitis in the UK is very low. We’ve probably got fewer than a couple of thousand cases a year, and the numbers of tests that are carried out for it are relatively small. So, although it’s a very important disease – one that can develop very rapidly, particularly in children – it’s an example of an area that has quite a strong clinical need but a very small market.

“STIs, on the other hand, comprise a huge market area in terms of numbers of tests. In the UK, there are probably between two and three million chlamydia and gonorrhoea tests carried out a year. And if you look at Europe and the US combined, together they account for 67 million chlamydia and gonorrhoea tests a year.”

Nevertheless, Clarkson hopes that starting with tests that can cater to a large well of patients will lead to greater clinical benefit in the long run, catalysing the adoption of rapid diagnostics technology like the io System across other areas of infection.

"The technology inside the io System could theoretically be used to test for a range of other bacteriological infections."

“The system has been developed so that it can be used in any clinical area – for any infectious disease,” explains Clarkson. “We’re starting with STIs, but by no means is that where we’ll stop. We’re already starting to work in other areas.”

On the horizon

Having raised around $35 million in Series D funding at the beginning of the year, the next logical step for Atlas Genetics will be the development of a test able to detect both gonorrhoea and chlamydia in patients. Another area the firm is keen to explore is respiratory infections, thanks to a new partnership Atlas Genetics recently forged with a Chinese diagnostics company that has a strong interest in that area.

“We’re going to be looking jointly at developing new tests that have a particular market in China, but they’re going to have a broad application globally,” says Clarkson.

For the moment, though, Atlas Genetics’ CEO is keen to emphasise the capability of the io System in catering to the largest possible number of patients at any given moment.

“We think that the clinicians benefit, because they have the tools with which they can provide patients with a better service,” he says. “And we think the healthcare system benefits, because we’re reducing antibiotics usage, and we’re reducing the time that people wait and, therefore, the spread of the disease in the community.

The cartridge of the io System, in which the detection technology is housed.
The io System can detect the presence of chlamydia in under half an hour.
STIs are a big market in terms of numbers of tests performed. Europe and the US account for 67 million chlamydia and gonorrhoea tests a year.

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