
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
Ms Shelly Sanders
P: +61 (03) 99182030
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
GD Vic – Healius Pathology Pty Ltd
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Mar 2024
Last Activity Date
02 Apr 2021
Service | Product | Determinant |
---|---|---|
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | Apolipoprotein E genotyping; 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 - 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 | ||
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 |
Quantitative calculation of p210 positive BCR::ABL1 transcripts | ||
Myeloproliferative disorders | ||
Formalin-fixed paraffin-embedded (FFPE) tissues | KIT mutation analysis; Solid tumoursERBB2 mutation analysis | |
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 |
Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes | Blood | Breast cancer; Hereditary colorectal cancer; Inherited disorders; Spinal muscular atrophyOvarian cancer |
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 disordersOvarian cancer |
Hereditary breast and ovarian syndrome | ||
Breast cancer; Cystic fibrosis; Hereditary colorectal cancer; Inherited disordersOvarian cancer | ||
Breast cancer; Hereditary colorectal cancer; Inherited disorders | ||
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 |
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
27 Jun 2022
END OF SCOPE