
National Association of Testing Authorities, Australia
Scope of Accreditation
LifeStrands Genomics (Australia) Pty Ltd
Scope of Accreditation
LifeStrands Genomics
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - DNA extraction | Blood | Viable DNA for sequencing and other molecular assays |
| Cytology samples; Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue | Viable DNA for sequencing and other molecular assays | |
| Molecular genetics - Detection and characterisation of cell free RNA (cfRNA) and/or cell free DNA (cfDNA) and/or cell free TNA (cfTNA) and/or circulating tumour DNA (ctDNA) in cancer screening and/or cancer genetic testing | Blood; Body fluids; Extracted DNA; Liquid biopsy; Plasma | Copy number variation (CNV); Exon skipping; Gene fusion; Indels; Nucleic acid analysis for specific variants; Single nucleotide variants (SNVs); Solid tumours |
| Blood; Body fluids; Extracted RNA; Liquid biopsy; Plasma | Copy number variation (CNV); Exon skipping; Gene fusion; Indels; Nucleic acid analysis for specific variants; Single nucleotide variants (SNVs); Solid tumours | |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changes | Extracted DNA | MLH1 promoter methylation analysis |
| Copy number variation (CNV); Somatic mutation detection | ||
| Homologous recombination deficiency (HRD) | ||
| Copy number variation (CNV); Microsatellite instability analysis; Somatic mutation detection | ||
| MGMT promoter methylation analysis | ||
| Extracted DNA; Extracted RNA | Copy number variation (CNV); Gene fusion; Microsatellite instability analysis; Somatic mutation detection; Tumour mutation burden (TMB) | |
| Copy number variation (CNV); Gene fusion; Somatic mutation detection | ||
| Extracted RNA | Gene fusion; Somatic mutation detection | |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted panels for inherited (germline) DNA/RNA changes | Extracted DNA | Inherited cancer syndromes; Solid tumours |
| Molecular genetics - RNA extraction | Blood | Viable RNA for molecular diagnostics; Viable RNA for sequencing |
| Cytology samples; Formalin-fixed paraffin-embedded (FFPE) tissues; Tissues | Viable RNA for molecular diagnostics; Viable RNA for sequencing | |
| Viable RNA for molecular diagnostics; Viable RNA for sequencing | ||
| Molecular genetics - Screening for an unknown mutation - Targeted panels for non-inherited (somatic) DNA/RNA changes | Cytology samples; Formalin-fixed paraffin-embedded (FFPE) tissues; Tissues | Solid tumours |
| Molecular genetics and/or cytogenetics - Bioinformatic analysis | DNA sequences; FASTQ files | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
| DNA sequences; FASTQ files; RNA sequences; VCF files | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
21166
Site No.
25462
Print date
10 May 2026
END OF SCOPE