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Genetic Analysis Nabs IVDR Certification for Microbiome Fecal Collection Kit

NEW YORK – Norwegian microbial diagnostic firm Genetic Analysis said Monday that its GA-map Sample Collection Kit has obtained CE-IVD marking under the EU's In Vitro Diagnostic Regulation (IVDR).

The GA-map Sample Collection Kit, which allows for fecal sample collection at home, inactivates bacteria and viruses and can preserve microbial profiles at room temperature for up to four weeks and at -20° C for up to six months, the company said.

The GA-map Sample Collection Kit is developed to be used in conjunction with the GA-map Dysbiosis Test, a CE-marked probe-based gut microbiota test that can diagnose and characterize dysbiosis in patients with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), according to Genetic Analysis.

Oslo-based Genetic Analysis said the GA-map Sample Collection Kit will now be commercially available to researchers and laboratories in need of fecal collection sampling, as well as directly to consumers.

"Having acquired the certification, we can now expand our commercialization efforts to a significantly broader customer base, thereby enhancing our sales potential and at the same time strengthening our presence in the microbiome analysis field," CEO Ronny Hermansen said in a statement.