MLSBioDNA has obtained certification in Good Manufacturing Practices, opening the way for the company to offer services to the pharmaceutical industry.
The company was approached by the Federation of Industry last June as two of its members required a GMP-certified company to test its water and other elements.
"It meant that we had to invest in more equipment and lay down very stringent procedures," quality manager Marisa Cassar said.
"It requires many more quality systems, control systems and paperwork but we now have a three-year certification."
MLSBioDNA is already doing work for the two companies and another, while it is trying to get a fourth interested.
The company was set up in November 2005 to carry out DNA testing, operating from the Corradino Business Incubation Centre (KBIC).
Ms Cassar explained that the initial outlay was steep.
"We had to spend over €350,000 on equipment to get started as this is not a service that you can offer piecemeal. We needed the whole set-up before we could offer the service," she explained.
"We would never have managed without the involvement of Medical Lab Services (MLS), a St James Group company, which is our joint partner. And we would never have been able to get going with KBIC as the centre enabled us to get moving quickly. Alas, the only ones we felt that we could have got more help from was Malta Enterprise, especially in view of the fact that we represent not only innovation but also a service to the local industry."
Ms Cassar and her colleague Christopher Vidal knew that there was a niche in the market for their services. They both previously worked with Synergene, a company offering similar services which has since closed down, leaving them without competitors.
They started off offering mainly paternity testing - it currently does around 80 a year - and forensic analysis for the courts, later adding clinical testing for infections such as chlamydia. DNA testing is very accurate. There is only a 1 x 108 chance of two people having the same DNA, unless they are identical twins.
"Since the population of the world is less than that, it is unlikely to find a match!" she laughed.
"We started doing clinical tests around 18 months ago, mostly routine tests referred from St James."
MLSBioDNA also obtained ISO 17025, which enables it to carry out food testing but Ms Cassar admitted that the company had very few clients.
"Unfortunately food processing companies and food preparation companies tend to do as little as possible; indeed we feel some fall far short of what they should be doing," she said.
"And in many cases companies do not use accredited labs."
The company can also use DNA testing to identify bacterium causing infections, such as salmonella, with results taking far less time than growing cultures in dishes.
"For example, it would take us just two or three days to identify TB whereas it would take three weeks for a culture to identify the exact bacteria. The sooner it is identified, the sooner the patient can be given the right treatment," she said. She also lamented that the public health department sends tests overseas, maintaining that MLSBioDNA could do them for half the price.
"We could also offer our sequencer to the university, which also sends its material overseas. It seems a shame that our services are not used locally. We are very busy but the equipment has considerable spare capacity! And it costs thousands of euros a year to keep our food testing accreditation. We believe it is important for this service to be available in Malta but we need support.
"And we are also interested in investing in research. We would like to develop new tests here."
The company was approached by the Federation of Industry last June as two of its members required a GMP-certified company to test its water and other elements.
"It meant that we had to invest in more equipment and lay down very stringent procedures," quality manager Marisa Cassar said.
"It requires many more quality systems, control systems and paperwork but we now have a three-year certification."
MLSBioDNA is already doing work for the two companies and another, while it is trying to get a fourth interested.
The company was set up in November 2005 to carry out DNA testing, operating from the Corradino Business Incubation Centre (KBIC).
Ms Cassar explained that the initial outlay was steep.
"We had to spend over €350,000 on equipment to get started as this is not a service that you can offer piecemeal. We needed the whole set-up before we could offer the service," she explained.
"We would never have managed without the involvement of Medical Lab Services (MLS), a St James Group company, which is our joint partner. And we would never have been able to get going with KBIC as the centre enabled us to get moving quickly. Alas, the only ones we felt that we could have got more help from was Malta Enterprise, especially in view of the fact that we represent not only innovation but also a service to the local industry."
Ms Cassar and her colleague Christopher Vidal knew that there was a niche in the market for their services. They both previously worked with Synergene, a company offering similar services which has since closed down, leaving them without competitors.
They started off offering mainly paternity testing - it currently does around 80 a year - and forensic analysis for the courts, later adding clinical testing for infections such as chlamydia. DNA testing is very accurate. There is only a 1 x 108 chance of two people having the same DNA, unless they are identical twins.
"Since the population of the world is less than that, it is unlikely to find a match!" she laughed.
"We started doing clinical tests around 18 months ago, mostly routine tests referred from St James."
MLSBioDNA also obtained ISO 17025, which enables it to carry out food testing but Ms Cassar admitted that the company had very few clients.
"Unfortunately food processing companies and food preparation companies tend to do as little as possible; indeed we feel some fall far short of what they should be doing," she said.
"And in many cases companies do not use accredited labs."
The company can also use DNA testing to identify bacterium causing infections, such as salmonella, with results taking far less time than growing cultures in dishes.
"For example, it would take us just two or three days to identify TB whereas it would take three weeks for a culture to identify the exact bacteria. The sooner it is identified, the sooner the patient can be given the right treatment," she said. She also lamented that the public health department sends tests overseas, maintaining that MLSBioDNA could do them for half the price.
"We could also offer our sequencer to the university, which also sends its material overseas. It seems a shame that our services are not used locally. We are very busy but the equipment has considerable spare capacity! And it costs thousands of euros a year to keep our food testing accreditation. We believe it is important for this service to be available in Malta but we need support.
"And we are also interested in investing in research. We would like to develop new tests here."