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Microba Life Sciences becomes first Australian microbiome company granted ISO15189 accreditation by NATA

Microba has applied its world-leading technology for microbiome analysis to unlock diagnostic applications, receiving ISO15189 accreditation for a new untargeted NGS based assay of stool samples.

The hypothesis-free testing method, MetaPanelTM, can identify multiple pathogens simultaneously from a single sample and was developed in partnership with Australian hospitals and leading health care practitioners.

Microba’s advanced bioinformatics analysis and laboratory processing pipelines at the Translational Research Institute in Brisbane have received ISO15189 accreditation to allow the use of MetaPanelTM, 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 program is delivered by NATA (The National Association of Testing Authorities, Australia) 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.

“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.”

Associate Professor Paul Griffin, Director of Infectious Diseases at Mater Hospital

Through validation studies conducted on over 2,500 samples, the untargeted assay performance correlated to traditional diagnostic methods, in a shorter time frame with comparable or improved sensitivity and improved specificity.

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.

“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,” she added.

Microba’s DNA extraction, sequencing, secondary and tertiary analysis (bioinformatics) are also included in the scope of the ISO15189 accreditation.

Further to this accreditation, the accuracy of Microba’s bioinformatic tools has been published in Frontiers in Microbiology and its sample collection device benchmarked in ISME Communications.

Partners interested in accessing Microba’s world-leading microbiome analysis can contact Microba directly.

About ISO15189 Human Pathology Accreditation by NATA

ISO 15189 is the international standard that specifies the requirements for quality and competence of medical laboratories.

NATA ISO15189 accreditation is recognised internationally and is part of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangements (MRA).

NATA’s accreditation program for medical laboratories is delivered in collaboration with the Royal College of Pathologists of Australasia (RCPA). In addition to ISO15189, the program adopts the relevant National Pathology Accreditation Advisory Council (NPAAC) standards as applicable to any given laboratory’s services.

Details of Microba’s accreditation status are available on the NATA website.