
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
Mr Timothy Gunzburg P: +61 (03) 92440336
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
GD Vic – Healius Pathology Pty Ltd
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
02 Mar 2030
Last Activity Date
28 Aug 2025
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | Gilberts disease |
| Cystic fibrosis; Fragile X | ||
| Factor V Leiden; HLA-B27; Haemochromatosis; Methylenetetrahydrofolate reductase (MTHFR); Prothrombin variant; Thrombophilia | ||
| Coeliac disease | ||
| Thiopurine methyltransferase (TPMT); α1-Antitrypsin | ||
| α-Thalassaemia | ||
| Molecular genetics - DNA extraction | Blood; Buccal swabs | DNA storage for future analyses; Viable DNA |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood | Quantitation of p190 positive BCR::ABL1; Quantitation of p190 positive BCR::ABL1 transcripts |
| Myeloproliferative disorders | ||
| Blood; Bone marrow | Blood borne tumours; FLT3-ITD (internal tandem duplication) mutation; FLT3-TKD (tyrosine kinase domain) mutation; JAK2 exon 12 mutation | |
| Quantitation of Nucleophosmin 1 (NPM1) | ||
| Quantitation of p190 positive BCR::ABL1 | ||
| Nucleophosmin 1 (NPM1) mutant transcripts | ||
| Quantitation of Nucleophosmin 1 (NPM1) | ||
| Quantitation of p210 positive BCR::ABL1 transcripts | ||
| Quantitation of p190 positive BCR::ABL1 | ||
| 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 | ||
| 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 – breast cancer; BRCA1 somatic mutation testing – ovarian cancer; BRCA1 somatic mutation testing – prostate cancer; BRCA2 somatic mutation testing – breast cancer; BRCA2 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; Formalin-fixed paraffin-embedded (FFPE) tissues | Blood borne tumours |
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes | Blood | Cystic fibrosis; Fragile X; Spinal muscular atrophy |
| Blood; Buccal swabs | Congenital adrenal hyperplasia; Cystic fibrosis transmembrane conductance regulator (CFTR); Fragile X messenger ribonucleoprotein 1 (FMR1) related disorders; Gaucher disease; Haemoglobin subunit alpha 1 (HBA1); Haemoglobin subunit alpha 2 (HBA2); Haemoglobin subunit beta (HBB); Haemophilia A; Survival of motor neuron 1 (SMN1) | |
| 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 | Breast cancer; Cystic fibrosis; Hereditary colorectal cancer; Inherited disorders; Ovarian cancer |
| Hereditary breast and ovarian cancer syndrome | ||
| Breast cancer; Hereditary colorectal cancer; Inherited disorders; Solid tumours | ||
| Cystic fibrosis; Familial hypercholesterolemia | ||
| 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 |
| Foetal RhD status | ||
| Molecular genetics - Predictive genetic testing - Targeted genes | Blood | Breast cancer; Hereditary colorectal cancer; Inherited disorders |
| Breast cancer; Hereditary colorectal cancer; Inherited disorders | ||
| Molecular genetics - RNA extraction | Bone marrow | RNA storage for future analyses |
| 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
29 Oct 2025
END OF SCOPE