OmegaQuant omega-3 tests gain European approval

15-May-2019 - Last updated on 15-May-2019 at 14:31 GMT

US-based OmegaQuant is aiming for European growth, as the company celebrates its recent EU medical device approval by setting up a new lab in the UK.

OmegaQuant’s Omega-3 Index and Prenatal DHA test kits are now approved for commercial sale in the EU market after being registered in the EU as in vitro diagnostic medical devices, says the firm.

The ‘Omega-3 Index’ test measures the amount of omega-3s EPA and DHA in the blood and it has been used in more than 200 clinical studies, while its newer ‘Prenatal DHA Test’, launched in February, is based on research that a certain level of DHA in the blood can significantly reduce a pregnant woman’s risk of preterm birth.

The approval and CE-marking of both tests as medical devices, alongside set up of a new lab in the UK, means the company’s tests are now fully accessible to all EU customers – using the same testing methodology as the US and AUS.

“We have had clients ask how they can get our omega-3 test panels in Europe and this will now allow us to service them and provide results in a timelier manner,” said Jason Polreis, CEO, OmegaQuant.

“We are looking forward to bringing an at-home collection kit to the EU market to make access to the Omega-3 Index and Prenatal DHA tests convenient, so individuals can personalise their omega-3 intake.”

UK-based analysis

OmegaQuant is partnering with the Nutritional Analytical Service (NAS) at the Institute of Aquaculture at the University of Stirling, Scotland, to carry out the analysis of its omega3 tests coming in from European consumers, noted Polreis.

“This way we are offering the same accurate, precise and scientifically validated methods at our three laboratories covering North America, AsiaPacific and now Europe,” he said.

Welcoming the announcement, James Dick, NAS Technical Manager, said: “We are delighted to work with OmegaQuant to provide this important service to their European customers.”

“This partnership recognises the internationally-renowned expertise of both partners in testing for omega-3 fatty acids and we are looking forward to developing this exciting new partnership.”