Genetic Analysis AS announces CE-IVDR marking for its GA-map® Sample Collection Kit

Oslo, Norway, November 26, 2024 – Genetic Analysis AS (the “Company”, Ticker: GEAN) is proud to announce that its GA-map® Sample Collection Kit has obtained CE-IVD marking under the In Vitro Diagnostic Regulation (EU) 2017/746. The GA-map® Sample Collection Kit is a device that simplifies the sample collection process, allowing easy and user-friendly collection of fecal samples at home, without compromising the quality and integrity of the test results. It is a user-friendly kit for at-home fecal sampling and contains a stabilizing buffer for sample preservations up to 2 weeks at room temperature (5-25°C), 4 weeks at 2-8°C and for longer storage, samples can be frozen at -20°C. The CE-IVD marking enables broader market access, allowing for increased commercialization opportunities to a wider range of end customers in the European markets.

The GA-map® Sample Collection Kit is now commercially available and will also be offered as a stand-alone product for researchers and laboratories in need of fecal collection sampling, as well as a direct-to-consumer setting. The GA-map® Sample Collection Kit has been designed 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). The market for Microbiome analysis is growing rapidly, and GA is changing the market by lowering the entry barrier for smaller labs to start microbiome testing. The new collection kit is a great complementary product to the Company’s offering to the research lab customers.

CEO Ronny Hermansen comments:
”The CE-IVD marking of the GA-map® Sample Collection Kit demonstrates that the product meets the high standards of quality, safety, and performance required by the In Vitro Diagnostic Regulation (EU) 2017/746. 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. We believe that our products can make a difference in the diagnosis and management of patients with gut-related disorders, and we look forward to bringing them to more markets and regions in the near future.”