- Status Complete
- Type New application
- Pre-PASC consultation Not applicable
- Pre-MSAC consultation Closed
- Outcome Supported
Application details
Reason for application
New MBS item.
Service or technology in this application
The applicant has described the proposed medical service as 'Sequencing and analysis of the complete nucleotide sequence of the microbial genome (bacterial, mycobacterial, or viral) of an isolate or to characterise an organism from a patient for the purpose of determining the antibiotic resistance markers (resistome) of the isolate to guide the patient’s treatment and/or chemoprophylaxis of close contacts. WGS usually involves ‘shotgun’ sequencing of short reads that are either assembled de novo or mapped onto a high-quality reference genome. Genome-wide analysis can identify changes conferring resistance to standard of care antibiotics as well as newer antimicrobials for which established phenotypic susceptibility testing guidelines or protocols are not available.'
Type: Investigative
Medical condition this application addresses
The applicant’s response is: ‘Antimicrobial resistance, also referred to as antibiotic resistance, is defined as the ability of a microorganism to reproduce in the presence of a specific antimicrobial compound. Of particular concern is the emergence of multiple drug resistant pathogens associated with the widespread use of antibiotics and high-density clinical care that are capable of causing outbreaks and epidemics. Whole genome sequencing (WGS) provides rapid and simultaneous screening of all clinically-relevant mutations in close to real-time to predict a pathogen’s full resistance profile to multiple drugs (the ‘resistome’) in order to guide a patient’s treatment and/or the chemoprophylaxis of close contacts. The literature describes the use of WGS to determine and characterise resistance in numerous clinically relevant pathogens including, but not limited to: Campylobacter; Escherichia coli; Klebsiella pneumoniae; Enterobacter cloacae; Pseudomonas aeruginosa; Bacteroides; Salmonella; Staphylococcus aureus; Streptococcus pneumoniae; Neisseria gonorrhoeae; Acinetobacter baumannii; Clostridium difficile and Plasmodium falciparum. The most common reported use of WGS for the determination of resistance; however, is for the pathogen Mycobacterium tuberculosis. Given the extensive list of potential pathogens and their associated clinical conditions, this application will focus on Mycobacterium tuberculosis as an exemplar of how WGS provides rapid and accurate characterisation of antimicrobial resistance.’
Application documents
Application form
Consultation survey
PICO confirmation
Public summary document
PICO confirmation
Public summary document
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Consultation survey and deadlines
- PASC consultation: Not applicable
- MSAC consultation: Closed 11 February 2022
Meetings to consider this application
- PASC meeting: 15 to 16 April 2021
- ESC meeting: 10 to 11 February 2022
- MSAC meeting: 31 March to 1 April 2022