Microbio receives ISO 13485:2016 certification
Following an audit by British Standards Institution (BSI Group), Microbio was granted ISO 13485:2016 certification for its Quality Management System.
InfectID-BSI tests approved for sale in Europe and UK
Microbio’s flagship sepsis test, designed to identify 26 common sepsis-causing pathogens in less than 3 hours received clearance for sale in Europe under IVD Directive 98/79/EC
InfectID-COVID-19 tests approved for sale in Europe
Microbio developed two SARS-CoV-2 tests and received approval for sale in Europe under IVD Directive 98/79/EC
- InfectID-COVID-19-Replication identifies the presence of replication-competent (the ‘live’, multiplying) SARS-CoV-2 virus
- InfectID-COVID-19-Detection identifies the presence of the SARS-CoV-2 virus, including the active virus and inactive particles being shed by the body.
Commercialisation potential acknowledged with Accelerating Commercialisation Grant
In late 2020, Microbio was awarded a Federal Government Accelerating Commercialisation Grant to commercialise InfectID-Blood Stream Infection (BSI) diagnostic assay.
Series A capital raise supports expansion of team
A Series A capital raise closed on 30 September 2020. This funding allowed for the continued growth of the team to facilitate the commercialisation of InfectID. The emergence of COVID-19 motivated the team to develop a SARS-CoV-2 test designed to identify the presence of replicating virus.
Seed funding raised to conduct preclinical verification
An initial funding round provided the capital to establish the laboratory research team. Preclinical testing began on patient whole blood samples in two Queensland Hospitals. Early results indicate >99% specificity for the 25 most common sepsis-causing pathogens:
- Gram-Negative Bacteria
- Escherichia coli
- Enterobacter cloacae
- Serratia marcescens
- Proteus mirabilis
- Klebsiella pneumoniae
- Klebsiella aerogenes
- Haemophilus influenzae
- Pseudomonas aeruginosa
- Citrobacter freundii
- Acinetobacter baumannii
- Stenotrophomonas maltophilia
- Enterococcus faecalis
- Gram-Positive Bacteria
- Enterococcus faecium
- Streptococcus agalactiae
- Streptococcus pyogenes
- Streptococcus pneumoniae
- Streptococcus anginosus
- Streptococcus bovis
- Staphylococcus epidermidis
- Staphylococcus aureus
- Candida albicans
- Candida tropicalis
- Candida krusei
- Candida parapsilosis
- Candida glabrata
Microbio founded to take InfectID to market
Microbio was founded in 2017 by Dr Huygens and Paul Carboon. Their aim was to build a scientific and commercialisation team to bring Microbio’s pathogen diagnostic test out of the laboratory and into the market to benefit human health and wellbeing.
Clinical research demonstrates the approach’s specificity
In 2015, Dr Huygens led a collaborative trial with the Microbiology Central Laboratory, Pathology Queensland, which involved testing 300 patient samples: 100 negative samples and 200 positive samples. The study found that InfectID had a specificity of 98.5% in correctly identifying bacterial species from blood samples.
A novel pathogen identification approach using DNA ‘fingerprints’
Dr Flavia Huygens has developed and validated a process that uses Single Nucleotide Polymorphisms (SNP’s) to delineate bacterial populations by mathematically maximising the resolving power of these SNP’s. The test homes in on these SNP’s, the pathogen’s DNA ‘fingerprint’, found at a specific point in its genetic code. By focusing on SNP’s rather than the whole genome, the process is fast, inexpensive, highly sensitive and can be adapted to address different target pathogens.
This technology was considered a world-first and is unique in its design and application, leading to several publications.
The test was refined and became InfectID, which uses real-time PCR followed by high-resolution melt-curve analysis to identify pathogen species directly from whole blood without the need to pre-culture.