Genetic Analysis DNA-Based GA-Map™ IBS Dysbiosis Test Receives CE Mark Approval

Molecular test gives doctors information about alterations in the gut microbiota of their IBS patients

Norwegian molecular diagnostics company Genetic Analysis has announced its GA-map™ IBS Dysbiosis Test has received CE mark approval. This important step will make it possible for gastroenterologists to perform molecular testing of dysbiosis (imbalances in microbiota) on a routine basis.

Genetic Analysis CEO Kari Stenersen welcomed the news: “We believe the GA-map™ IBS Dysbiosis Test will be an important tool in IBS management since our studies across a range of clinic populations have shown that on average, 68% of IBS patients experienced dysbiosis. At the recent UEGW in Germany, we received a great deal of interest from clinicians looking to use the test and will now be able to satisfy this demand through a network of laboratories. The first, in Oslo, is already operational.”

The GA-map™ IBS Dysbiosis Test can be run in any molecular diagnostics laboratory. Bacterial gDNA is isolated from patient stool samples and used as template in a PCR reaction. The proprietary PCR primer pair is directed towards conserved regions of the 16S rRNA gene. The resulting amplicons are targeted by GA’s unique DNA probe mix followed by fluorescent detection upon hybridization. Finally, the patient’s microbiota profile is derived using an algorithm specifically designed for assessing dysbiosis in IBS patients.

“The test gives the doctors information about alterations in the gut microbiota of their IBS patients in a cost
effective manner ,” continues Stenersen. “We are also on track to submit a US FDA application in early 2015,”