On-the-spot diagnostics

Enigma Diagnostics is close to perfecting a system that provides on-the-spot analysis and results within 45-60 minutes.

The Enigma story began in the Defence Science and Technology Laboratory, (Dstl) at Porton Down. The Ministry of Defence wanted to move away from centralised and expensive laboratories and sought fast, accurate, portable and easy to use systems.

Enigma’s technology grew from the MoD’s need for swift diagnosis of the effects from what the military dub NBC attacks.

NBC stands for nuclear, biological and chemical warfare. Had Saddam Hussein resorted to such desperate measures in either of the Gulf Wars, our forces would have had an immediate call for rapid testing and treatment.

Finding that none of the existing instruments or processes matched the MoD specification, the Dstl scientists designed their own, producing the portable field laboratory, in 2004.

With the groundswell towards commercialising government technology, Enigma was formed in 2004, backed by Dstl and the private equity company Porton Capital. The Dstl staff transferred to Enigma.

Polymerase chain reaction (PCR) provides the heart of the Enigma package. Developed in the early 1980s, PCR involves thermal cycling, heating and cooling to substantially amplify a piece or copies of DNA.

Widely used in research and medical laboratories, PCR’s uses include genetic fingerprinting and the detection of hereditary and infectious diseases.

Centralised facilities use large PCR setups. To save on time and costs, they collect specimens into batches and test for one disease at a time. Setting up the sequences demands skilled hands, as does interpreting the results.

Enigma’s Mini Lab (ML) is light, portable and modular. Up to eight modules can be connected to the machine’s computer, which can accept a different sample for a different disease from each module simultaneously.

The process is called real-time PCR. The ML uses a sampling cassette specific to the disease being tested. A specimen of blood, faeces, urine or sputum on a swab is placed in the cassette and analysed. The ML is unique in accepting a swab direct.

Chemicals in the cassettes are freeze-dried and have no special storage or supply chain problems. The machine is self-cleaning and cross-contamination is impossible.

Results come in two formats, a simple yes/no or retest printout, and the underlying data from the test.

Each result is automatically compared with reference laboratory standards to ensure high accuracy and consistency.

Straightforward testing for a disease can be undertaken with a minimum of training. The underlying data, stored in the PC, can be downloaded to a laboratory management or hospital system for analysis or comparison by scientists or physicians.

Multi-lingual capability will be available and soon a ruggedised version that operates on battery power.

Enigma has spent huge amounts of time and money developing the ML. Spurred by a government grant in 2006 to examine chlamydia screening, the company conducted extensive market research in Europe and the USA.

Clinicians, nurses, technicians and many others were interviewed to ascertain their needs — the voice of the customer. The outcome is the ML.

Clinical trials of the instrument will be conducted during 2010, with a device scheduled on the market in the autumn.

Part of Enigma’s deal with Dstl was a substantial portfolio of patents. It owns more than 200 granted patents for instruments, systems and the next generation of machines.

Pivotal to its success is freedom to operate licences from Roche, Celera and Applied Biosystems. These are large pharma companies that own the rights to real-time PCR technology, licensing them only where significant income is generated.

Enigma’s chairman John McKinley said: “We contested certain patents and in return for withdrawing our opposition, we now have licences worth millions of pounds.”

Key, too, are the rights to use Roche’s fast chemistries, which complement the Enigma systems.

“Our initial market will focus on pandemic flu,” explained Mr McKinley.

“We have a 12-year contract with Glaxo Smith Kline on testing. After that, sexually transmitted diseases, hospital acquired infections and multi-drug resistant TB are on our radar.

“The hospital infections are now a serious problem in every country and TB is a major issue with the World Health Organisation.”

Mr McKinley’s legal career, first as a barrister and then a solicitor, led him to work with a diagnostics company. In 2005, he was asked to become chairman of Enigma.

Now at three sites, Porton Down, Milton Park and San Diego, Enigma has 45 employees. Staff numbers will double in the next eight months as regional offices are opened across Europe.

Mr McKinley added: “We are firmly targeting point-of-care medicine. Many patients never return to follow-up their results. Our technology means results while you wait, and immediate treatment.”