31 August 2005

The Web

As easy as DNA

Synergene Biotechnology Group has just been awarded ISO accreditation putting them at the forefront of European laboratories offering DNA profiling services. Kevin Camilleri, operations manager at Synergene believes accreditation will allow the company to compete on a more level playing field on the international scene.
Having set up shop in Malta in 1999 and after an investment in excess of USD6 million, Camilleri says the company’s ultimate aim is to list on the Alternative Market Listing (AIM), a stock exchange based in London.

Synergene has just been awarded ISO accreditation. What does this mean for the company?
On an international level, our ISO 17025 accreditation has placed Synergene amongst an elite group of international laboratories offering DNA Profiling Services. For example, only three labs hold such accreditation in the UK and there are no such labs in Italy, Poland or Portugal. Accreditation therefore allows us to compete on a more level playing field, since when dealing with international clients, accreditation always features as an important pre-requisite. In fact, since accreditation, Synergene has already concluded successfully several sub-contracting agreements with various international laboratories across Europe. We are also presently in negotiations with other labs from Germany, Italy and the UK.
On a local level, we are now the first privately owned laboratory to be accredited in Malta. By being the only accredited DNA testing laboratory in Malta we hope to see an increase in the use of our services by the local law enforcement agencies, particularly in the field of DNA Forensics. To date such testing has been sent abroad, at significantly higher costs than what Synergene can now provide the service for. Such expenditure can now be spent locally.

What response have you had locally to achieving accreditation and how do you think this accreditation will benefit Malta?
We have received a lot of positive support from various officials and key people within the Maltese legal community. Post accreditation we have organised a number of meetings and visits at Synergene to inspect the facility. The feedback received to date has been very encouraging. We have an upcoming visit from the Minister of Justice and Commissioner of Police in September and we look forward to the opportunity to present to them our capabilities and to discuss future collaboration for the benefit of the Maltese population.
In terms of benefits, as mentioned, we have said we are now in a position to assist Malta’s law enforcement agencies with our DNA testing portfolio. Synergene can offer better pricing than is presently being paid to overseas laboratories and with faster turn-around times. This naturally would extend the budget allocated to DNA testing in Malta and not limit DNA testing to just major cases.
In addition, we also want to propose the setting up of a DNA database of criminal offenders similar to that of the USA, Canada and the UK. This database would assist in identification of scene of crime samples to known criminals, thereby potentially solving a number of crimes simultaneously. I mean, let’s face it, the criminal population in Malta is relatively small. The expense of setting up such a database is not large, and technical assistance by foreign law enforcement agencies is available. So it is really a question of willingness of the authorities to sanction the project and decide who is going to manage the database.
In terms of economic benefits, one must bear in mind that Synergene is primarily an export company. Our success in marketing overseas will translate directly into much needed foreign direct income, as has been the case of the foreign direct investment brought into Malta by Synergene. In line with its policy of promoting exports, we therefore expect the government to support companies such as ours.

Why choose Malta to set up base?
Synergene is owned by a group of Australian investors with experience in biotechnology in Australia. Back in 1999, they were looking for a base in Europe for Synergene’s corporate headquarters. One important criterion was location; Synergene needed to be close to North Africa as well as Europe, thus the Mediterranean made an obvious choice. In addition, Malta has a well-educated multi-lingual workforce and solid financial and communications infrastructure. Finally, one cannot fail to mention the benefits of the Business Promotion Act, which are aptly managed by Malta Enterprise.

What is the investment that has gone into the company since its inception?
Synergene has invested in excess of USD6 million dollars to date, most of this money has been spent in Malta. One must remember that five years ago biotech was an emerging market where the learning curve can be steep and expensive. The company started out initially as a contract sequencing laboratory and invested heavily in a number of R&D projects that eventually did not prove fruitful. The company therefore had to revaluate its strategy and we focused more specifically on providing DNA profiling services, apart from our on-going R&D programmes. One must also remember that apart from investment in facilities and equipment, significant funds have also been invested in obtaining foreign technical expertise. With this investment in mind, our ultimate aim is to list on the Alternative Market Listing (AIM), a stock exchange based in London.

What services are offered by Synergene?
Synergene offers a number of molecular diagnostic services, however we are currently concentrating on promoting mainly DNA Profiling testing, which includes amongst others DNA Paternity testing, twin zygosity testing, DNA relationship testing and customised DNA forensic testing services. The demand for these services around the world is constantly growing as awareness and use of such testing increases. Obviously as more players enter this market this industry has become more competitive. That is why accreditation was important to succeed internationally.
Synergene also specialises in the provision of technical “know-how” particularly in countries where this technical expertise is limited. We are currently in advanced discussion with a number of government agencies particularly in North Africa. In the near future we are also looking at expansion into Greece and Italy as part of our overall expansion programme.

Yours is a very specialised field of operation. With Malta increasingly attracting more generic pharmaceutical companies, which target the same human resources skill base as yours, do you believe enough is being done by the country to boost the number of science graduates?
I believe that with its limited resources, the University of Malta is trying its best to produce an adequate supply of scientists. However, we are still far away from an ideal situation, particularly where more specific skill sets are necessary.
In our case, whilst the majority of Synergene’s staff is Maltese, we still have had to employ foreign expertise for certain positions within the company, as unfortunately such expertise is not readily available in Malta.
Therefore it is necessary that, apart from more specific post-graduate degrees, a system that allows for placement with international firms should also be developed and encouraged. The experience brought back by such placements is invaluable to local industry.

There are a number of confidentiality issues associated with DNA testing. How does the company protect the privacy of its clients?
Confidentiality is one of the top priorities at Synergene. We take all the necessary care to ensure that all data remains confidential and protected. For example, test results are only handled by the scientists performing the test and issuing the reports. The actual reports are stored separately both electronically and physically with limited access rights. Results are never given over the phone and only sent to contact information provided by the client. We operate on a very strict need-to-know basis as this protects both the client as well as our staff. In addition, in Malta we do not deal directly with the client, our testing is received through the referral of a general practitioner or directed to our experts from the law courts. We also operate within the strict guidelines of the Data Protection Act as well as accreditation restrictions. We take this issue very seriously.

The company also performs custom based research and you were involved in two non-human projects in Malta. How could the domestic market benefit from the services offered by Synergene?
DNA technology can be applied to a number of applications within different industries. For example, one of the projects we have been involved in was the genotyping of the local Girghentina and Gellewza grape varieties to confirm its indigenous origin. We believe that there exist a number of other local products that the government and local industry should endeavour to label scientifically as ‘unique’ to Malta.
Other examples include the field of food testing. Synergene will soon be in a position to offer two food-testing services: microbiology testing for quality assurance in food manufacturing and GMO testing i.e. testing for the presence of genetically modified organisms in food and beverage products. Synergene is an accredited laboratory and the new legislations on food testing that will soon be introduced will impose that food testing must be carried out by competent laboratories. The food and beverage industry will be able to subcontract its microbiology food testing to Synergene or else Synergene can act as an independent quality control laboratory. We therefore invite the industry to approach us and discuss their needs with us.

Given Synergene’s ability to conduct genetic profiling, which service could be an important element in the medical field of assisted procreation and in-vitro fertilisation, how do you view government’s attempt to regulate this field?
The need for some form of regulation in this field, I think, is felt by all concerned. The government however should ensure that it takes into consideration all cultural, ethical and scientific issues and does not let extremism prevail in any of the arguments put forward.

Given Italy’s restrictive laws on assisted procreation, does Malta have the potential of developing into a centre of excellence in this field attracting also Italian researchers and customers?
Personally, I do not envisage such a scenario. However, I guess it is up to the organisations involved to promote their services internationally if they feel there is an opportunity there. At Synergene we do not have any plans to enter into this area whatsoever.

What investment is going into research and development?
In the last year, the company has curtailed its R&D programme in order to concentrate on obtaining our ISO certification, as well as promoting our DNA Profiling testing portfolio internationally. However, we are now at a stage where we are evaluating which R&D programmes to invest in. Current R&D includes the localization and identification of genes predisposing to hereditary forms of Osteoporosis and Epilepsy. We are also looking into developing our molecular methodologies for testing for infectious diseases, which our international market research has shown to be in high demand. One must bear in mind that R&D is an expensive exercise and does not always guarantee a direct result especially when dealing with nature! Therefore successful R&D is very much an expensive long-term commitment.

What markets does the company seek to exploit in the medium to long term?
Synergene wants to position itself as one of the leading providers of DNA Profiling services in Europe and North Africa. We will be pushing hard to be present in as many countries as possible mainly through agencies and sub-contracting agreements. In addition, we are also working to gain a foothold in the lucrative UK DNA forensics market. This market is estimated at approximately GBP40 million annually. We already invested in obtaining local representation and negotiations are underway for Synergene to service some of the overflow of samples resulting from the backlog presently being experienced in the UK. We hope to see the results of our efforts in the forthcoming year.
In addition to this there are other developments in the pipeline, which at this point I cannot divulge information about as they are in the negotiation stage and are relatively sensitive.

Kevin Camilleri was interviewed by Kurt Sansone

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