Regulation

The myBioma gut microbiome analysis is based on the analysis of microbial DNA in a stool sample. Scientific studies on the Western population and specially developed bioinformatic algorithms are used to evaluate the data. The test results are then presented. In addition to the visualization of the test results, customers receive individual recommendations for action. The evaluations and recommendations for action can be used as a basis for further investigations or recommendations.
myBioma markets the analysis either directly to end customers or via partners (e.g. doctors, dieticians, alternative practitioners, etc.). In addition, the team also offers white-lable solutions as well as "Software-as-a-Service" (SaaS).

In order to deliver the best quality, myBioma has become the first company in the field of microbiome analysis to be double ISO certified (ISO 9001:2015 and ISO 13485:2016). Thus, the company as well as the gut microbiome analysis meets the leading international industrial quality and regulatory standards. ISO 13485 is a harmonized standard that defines the requirements for a quality management system in which a company must demonstrate that it is capable of providing medical devices and related services that consistently meet customer and regulatory requirements.

Further medical products and CE-IVD markings are being worked on under the BiomeDx brand.