NUI Galway signs lucrative DNA test licensing deal with Roche subsidiary

Scientists at NUI Galway have developed a DNA-based test that can detect and identify life-threatening infectious diseases. The university has licensed the technology to a Roche subsidiary in a lucrative cash deal that will include royalty payments.

The university will also enter a collaborative research programme involving Roche and Innogenetics, a Belgian biotech company based in Ghent. "It is a serious deal," said Dr Terry Smith, general manager of the National Diagnostics Centre (NDC), based at NUI Galway.

"It is the largest biotechnology deal that has been done in Ireland. There is an up-front payment of €1.34 million (£1.1 million) shared by BioResearch Ireland and NUI Galway, and there is an anticipated royalty income. We could be talking in the order of £2 million per year," he said. "We have been working on this technology for 10 years. It at last validates the efforts people have put into the research."

Prof Frank Gannon, Dr Tom Barry and Dr Richard Powell invented the DNA-based test at the NDC and the Department of Microbiology in a programme funded by BioResearch Ireland. Worldwide patents were granted in 1997.

"We granted a licence for the technology to Innogenetics in 1997 with the view that they would sub-licence the technology," Dr Smith said. Roche Diagnostics, one of the world's largest medical diagnostics companies, has emerged as the secondary licensee.

Roche and Innogenetics will develop diagnostic tools particularly for the rapid diagnosis of infectious organisms for use in intensive care hospital departments. The original research collaboration between Galway and Innogenetics has also been ramped up. "The whole agreement is being expanded significantly," he said.

The original deal was for five years but this has been extended by three years and possibly more. "We are delighted with it. It is a fantastic deal. It stitches us in with the biggest molecular diagnostics company in the world."

The university has extensive experience in developing probes that can detect bacteria and fungi. NUI Galway's DNA approach involves looking for a particular DNA segment known as a "spacer" and known to exist in all bacterial species and fungi.

While all bacteria have spacer DNA there are small variations typical of each species, Dr Smith explained. "The DNA sequence varies from organism to organism. You can therefore find unique DNA sequences which distinguish different organisms. The main thing is every organism has it and this can be used to detect all organisms present. You can identify the details of each one."

The technique makes use of PCR, polymerase chain reaction, as a way to amplify even minute quantities of bacterial DNA. PCR, a technology owned by Roche, produces millions of copies of the bacterial DNA so that it can easily be detected.

If the bacterial DNA is present special chemical probes will fix to it to give a reading based on a simple change of colour in the test kit. The technology gives results in a matter of hours compared to current tests, which can take days.

The test is intended particularly for detection of life-threatening diseases such as septicaemia and meningitis, where rapid diagnosis can literally be a matter of life and death. The test also has application in other diagnostic areas such as respiratory diseases and sexually transmitted diseases.

The NDC will now remain involved in the further development of the test system. The next step will be to apply a new type of amplification called "real-time PCR", Dr Smith said. This method will be even faster, as the test can begin to deliver results while the PCR process is still progressing, using fluorescence to confirm bacterial or fungal DNA.

"That is the way we are planning to go with it - it is much quicker," Dr Smith said. He hopes that within four or five years they will have a system that can deliver results in just a few minutes. "It will also allow a computer to do the detection and then provide information to the doctor."

BioResearch Ireland was set up by the Government in 1988 as a vehicle for the commercialisation of biotechnology discoveries made in the universities and institutes. It has five university-based national biotechnology research centres including the NDC in NUI Galway and centres in University College Dublin, University College Cork, Trinity College and Dublin City University.

"This is a significant financial agreement for BioResearch Ireland and confirms the ability of Irish researchers to develop commercially relevant technology of international quality," said the firm's director, Dr Jim Ryan.