Biostella is a molecular diagnostics focused bioinformatics company combining expertise in molecular assays with biology, statistics and computer sciences. Biostella’s services include:
- In vitro device consultancy services
- Data Science
- Data analysis and report writing, including regulatory bodies and clinical trials
- Primer Design
- Assay Validation
IVD Design and Development
Biostella’s team are experienced in the preparation of samples in the IVD setting and amplification of the target through LAMP/RT-PCR etc, and the quantification of the target through fluorescence and/or electrochemical methods.
Data Analysis
Biostella understands molecular assay design and development from multiple perspectives, and we are able to design, test and analyse to determine: assay inclusivity, assay exclusivity, interferences, limitof-detection (LoD), specificicity and sensitivity. Our team is experienced in participating in both the analytical sciences efforts and the clincial efforts.
Biostella is powered by ZP, which means an ISO13485 team, taking products from ideas to regulatory approval, by leveraging biology labs and a 4000 sq meter manufacturing site.
