The Austrian company developed a lifestyle product to analyse the gut microbiome for end-consumers. Since the product launch across Europe in 2019, the company has gathered thousands of data points. In January 2021, the company had its successful surveillance audit for its certification according ISO 13485 (manufacturing of medical products) and ISO 9001 (quality management) – find out more. The company is currently preparing its software product line for specific indications in clinical settings. The transition to the medical field is also shown by a rebranding as Biome Diagnostics GmbH (www.biome-dx.com). The lifestyle product, myBioma, will not be affected and remains an important part of the company.
Co-founder of Biome Diagnostics GmbH, Dr.med.univ. Nikolaus Gasche, states: “Our focus is the development and successful launch of the first diagnostic software based on the genetic information of the gut microbiome. For this purpose, we use advanced bioinformatic algorithms and apply quality-controlled machine learning pipelines. We expect the launch early 2022.”
The outlook for Biome Diagnostics GmbH is bright. Currently, the company is enrolled in multiple clinical studies focusing on cancer prevention, diagnostics and therapies. The resulting microbiome data is fed into the analysis platform of the company. With an established quality management system, existing ISO certifications and scientific excellence, the path for a CE-IVD marked medical software is predetermined. Finally, Biome Diagnostics GmbH is planning on closing a financial round end of the year to facilitate a strong product rollout and further developments.
“This year we will complete two large studies in the area of cancer and microbiome. We are already working on positioning ourselves to CE-IVD-mark the product as soon as possible. Fortunately, we have great cooperation partners in and outside of Austria , who supports us to facilitate our ambitious goals“, says Barbara Sladek PhD, MBA, co-founder of Biome Diagnostics GmbH.