National Association of Testing Authorities, Australia
Scope of Accreditation
Genomic Diagnostics
Site
GD Vic – Healius Pathology Pty Ltd
Accreditation No.
19619
Site No.
22717
Date of Accreditation
17 Dec 2014
Contact
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
ISO 15189 (2012)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
02 Mar 2027
Last Activity Date
05 Sep 2023
Service | Product | Determinant |
---|---|---|
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood | Quantitative calculation of p190 positive BCR::ABL1 |
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
02 Mar 2027
Last Activity Date
05 Sep 2023
Service | Product | Determinant |
---|---|---|
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | α-Thalassaemia |
Thiopurine methyltransferase (TPMT); α1-Antitrypsin | ||
Coeliac disease | ||
Cystic fibrosis; Fragile X | ||
Fragile X; Gilberts disease | ||
Factor V Leiden; HLA-B27; Haemochromatosis; Methylenetetrahydrofolate reductase (MTHFR); Prothrombin variant; Thrombophilia | ||
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood | Qualitative calculation of p190 positive BCR::ABL1 transcripts; Quantitative calculation of p190 positive BCR::ABL1 |
Myeloproliferative disorders | ||
Immunoglobulin (Ig); Quantitative calculation of p210 positive BCR::ABL1 transcripts | ||
Blood; Bone marrow | Blood borne tumours; JAK2 exon 12 mutation | |
Formalin-fixed paraffin-embedded (FFPE) tissues | KIT mutation analysis; Non-small cell lung cancer and other tumours; Solid tumours | |
BRAF mutation analysis; EGFR mutation analysis; KRAS mutation analysis; NRAS mutation analysis; 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 | Formalin-fixed paraffin-embedded (FFPE) tissues | Solid tumours |
BRCA1 somatic mutation testing – ovarian cancer; BRCA2 somatic mutation testing – prostate cancer | ||
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Whole genome sequencing for non-inherited (somatic) DNA/RNA changes | Blood; Bone marrow | Blood borne tumours |
Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes | Blood | Breast cancer; Hereditary colorectal cancer; Inherited disorders; Ovarian cancer; Spinal muscular atrophy |
Spinal muscular atrophy | ||
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood | Spinal muscular atrophy |
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood | Cystic fibrosis; Familial hypercholesterolemia |
Hereditary breast and ovarian cancer syndrome | ||
Breast cancer; Cystic fibrosis; Hereditary colorectal cancer; Inherited disorders; Ovarian cancer | ||
Breast cancer; Hereditary colorectal cancer; Inherited disorders | ||
Breast cancer; Cystic fibrosis; Hereditary colorectal cancer; Inherited disorders; Ovarian cancer | ||
Molecular genetics - Non-invasive prenatal (genetic) screening | Maternal blood | Aneuploidy for chromosomes X and Y; Rare autosome aneuploidy and segmental genomic imbalances; Trisomy 13, trisomy 18, trisomy 21 |
Molecular genetics - Predictive genetic testing - Targeted genes | Blood | Breast cancer; Hereditary colorectal cancer; Inherited disorders |
Breast cancer; Hereditary colorectal cancer; Inherited disorders | ||
Molecular genetics/Cytogenetics - Bioinformatic analysis | DNA sequences | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
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.
19619
Site No.
22717
Print date
25 Nov 2024