Microba technology has been used for microbiome analysis to unlock diagnostic applications. This has led to the company receiving ISO15189 accreditation for a new untargeted NGS based assay of stool samples. This makes the company the first Australian microbiome company granted ISO15189 accreditation by NATA (The National Association of Testing Authorities, Australia).
Microba’s testing method
The hypothesis-free testing method, MetaPanel, has been designed to identify multiple pathogens simultaneously from a single sample and was developed in partnership with Australian hospitals and health care practitioners.
Microba’s bioinformatics analysis and laboratory processing pipelines at the Translational Research Institute in Brisbane have received ISO15189 accreditation to allow the use of MetaPanel in clinical settings for unbiased detection of causal agents of gastrointestinal infectious disease.
As the international standard for medical laboratories, ISO15189 accreditation ensures the validity and reliability of testing services for patient samples and involves an independent assessment of the laboratory’s pre-analytical, analytical and post analytical processes.
In Australia, the accreditation programme is delivered by NATA in collaboration with the Royal College of Pathologists of Australasia (RCPA).
Associate Professor Paul Griffin, Director of Infectious Diseases at Mater Hospital, explained that he expected to see significant growth in the use of this type of diagnostic test given the increased understanding of advanced sequencing technologies. He said: “Applying metagenomic analysis to stool samples for pathogen detection opens the opportunity to improve patient outcomes by enhancing our ability to detect, understand and track infectious diseases in a clinical setting.”
Dr Nicola Angel, Laboratory Director at Microba, said that achieving this accreditation is another important step in ensuring the rigour at every stage of Microba’s analysis, and ensuring partners can be confident in their results. She said: “We see a future where microbiome testing becomes a part of routine clinical care to improve patient outcomes, so ensuring our laboratory and processes meet the standards for valid and reliable test results has been at the centre of our approach to microbiome analysis.”
Image credit: Michael Marais