Regulatory

The myBioma gut microbiome analysis is based on the collection of microbial DNA from a stool sample. Scientific studies on the Western population are used to evaluate the data. The test results are presented via the myBioma App (iOS/Android) or via a PDF. In addition to the visualisation of the test results, the customer receives individual recommendations for action.
The evaluation 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 partner (e.g. doctors, dieticians, etc.). Additionally, myBioma has several white-label cooperation and also offers the software as a service (SaaS).

In order to deliver the best quality, myBioma is globally the first company in the field of microbiome analysis to be double ISO-certified. A further CE-IVD marking is being worked on under the brand BiomeDx.

Thus, the company and also the gut microbiome analysis meets the leading international industrial quality and regulatory standards according to ISO 13485, a harmonised standard that defines the requirements for a quality management system in which a company must demonstrate that it is able to provide medical devices and related services that consistently meet customer and regulatory requirements.

Moreover, myBioma complies with the European General Data Protection Regulation (DSGVO).