University of Bath biotech spin-out wins EU approval for ground-breaking chlamydia test

A small biotech that started life at the University of Bath has won approval from European regulators to sell a device that tests for the sexually transmitted disease chlamydia in just 30 minutes.

The makers of the diagnostic test from Atlas Genetics say it will be the first of its kind when it enters the market.

The test works by allowing doctors and nurses to take a swab, blood or urine sample from a patient, add it to a special device that resembles a printer cartridge, and then place it into a small machine, which analyses the data and spits out the results within 30 minutes.

"It is extremely easy to use," said chief executive John Clarkson. "What we’ve done is take a very complex workflow that would normally be run in a lab with a number of highly skilled people and several pieces of equipment and miniaturised that into single disposable cartridge where the process is quick and anyone can run it.

"The machine removes DNA from the sample and purifies it, allowing specific pieces of DNA, such as chlamydia DNA, to be copied multiple times and amplified to a level that is easily detectible. It then uses a novel electronic system to interrogate that DNA and gives a clear, unambiguous signal, if the disease is present."

The idea is that the test, called the 'io system', is relatively cheap to carry out and can be done in a doctor's surgery or clinic, rather than in a hospital or lab setting. Patients get their results on the day and can go home with a prescription.

"The aim is to solve a big problem in infectious disease in that diagnosis is delayed by several days because the test is sent to a lab," said Mr Clarkson.

Atlas boss John Clarkson"That means antibiotics are delayed and it increases the risk of the disease spreading and the patient's health deteriorating further."

Atlas was set up in 2005, but the io system has been in development for four years, after winning $30m of funding from Novartis' corporate venture fund. US pharmaceuticals giant J&J has also backed the fledgling firm, while Atlas works with UK-listed medical manufacturer Consort Medical to produce the cartridges.

"There are 67 million chlamydia and gonorrhoea tests done in Europe and the US a year so we will need to be able to meet that demand," Mr Clarkson said.

The company also has private equity backing from Life Sciences Partners, Swiss fund BB Biotech Ventures and RMI Partners, a Russian investor.

It has won funding from the Government's Innovate UK grant, the NHS, the South West Regional Development Agency, The Wellcome Trust and others. To date it has raised roughly £35m.

"We have no profit or revenue stream," Mr Clarkson said. "The only revenue we have comes in the form of minor grants and we are still entirely reliant on our backers."

Atlas is also working on a number of additional applications for the system, including tests for other sexually transmitted infections and hospital superbugs. A combined chlamydia and gonorrhoea test is about to go into clinical trials and is expected to get EU and US regulatory clearance by the end of 2017.

This is what the io system looks like: machine and cartridgeThrough a partnership with St George's Hospital in London, Atlas is developing a gadget that will not only identify the type of infection in a patient, but tell doctors which antibiotic would be suitable to treat the disease, although it's still early days.

With EU approval for the chlamydia test under its belt, Mr Clarkson said the next step was to trial the technology in a real-life clinical setting, rather than to generate sales.

"We are taking a progressive approach," he said.

"The first thing we want to do with the chlamydia test is work closely with a number of Genito-Urinary Medicine (Gum) clinics and see how best to integrate this type of testing into the clinical workflow and get the best outcome for patients. So the first priority is to get data on how to build clinical acceptance of the system."

When the time comes to commercialise io, Atlas will more than likely need to partner with a big pharmaceuticals company with an established marketing and sales team to get the product launched.

The US, Mr Clarkson said, offered the biggest potential in terms of sheer patient numbers.

“Today's regulatory clearance marks the beginning of the next phase of growth for Atlas," he said.

Source