Product News: Genetic Analysis Launches New DNA-Based GA-map™ IBS Dysbiosis Test at UEGW 2013

15 Oct 2013

Norwegian molecular diagnostics company Genetic Analysis yesterday launched the GA-map™ IBS Dysbiosis Test at the United European Gastroenterology Week in Berlin. In a major breakthrough, the DNA-based test makes it possible, for the first time, to effectively and on a routine basis analyze the composition of the gut microbiota (bacteria profile) and any dysbiosis.

Genetic Analysis CEO Kari Stenersen explained the background to the test: Numerous studies have suggested the role of gut microbiota in IBS, However, it is only recently that links between dysbiosis and IBS have been explored and therefore we thought it would be valuable to investigate how important dysbiosis (imbalance in microbiota) is for IBS. Working with leading experts in Scandinavia and Europe, we therefore initiated a series of studies in order to document the use of the GA-map™ IBS Dysbiosis Test in various IBS patient populations. We found that dysbiosis frequency in IBS patients ranged from 48-86% between the clinics. On average, 71% of the IBS patients experienced dysbiosis. The trials have now been extended with feedback from participating investigators backing our decision to bring GA-map™ IBS Dysbiosis Test to market.”

The GA-map™ IBS Dysbiosis Test can be run in any molecular diagnostics laboratory. Target DNA is first isolated from patient stool samples. Then conserved regions of the bacterial 16S rRNA gene are used as templates to amplify the more variable regions in-between that are unique for different bacteria. The final result is based on the patient’s microbiota profile and an algorithm specifically made for assessing dysbiosis in IBS patients.

“Within 72 hours, the physician will be able to receive results and prescribe appropriate treatment,” continues Stenersen. “The GA-map™ IBS Dysbiosis Test will be CE-marked at the end of the month and rolled out during the rest of the year in Europe, followed by a US FDA application early 2015,”