Northern Sydney Local Health District - Kolling Institute

Site

Cancer Genetics Diagnostic Laboratory – Kolling Institute

Accreditation No.

19626

Site No.

22731

Date of Accreditation

09 Dec 2014

Address

Level 9, Kolling Institute, Royal North Shore Hospital
St Leonards, NSW 2065
Australia

Contact

Prof Roderick Clifton-Bligh P: +61 (02) 94631680

Availability

Services available to external clients

Supervision

S (Specialised)

Scope of Accreditation

Cancer Genetics Diagnostic Laboratory – Kolling Institute

ISO 15189 (2012)

  • This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.

Human Pathology

Medicare expiry date

28 Feb 2027

Last Activity Date

09 Aug 2022

Service Product Determinant
Molecular genetics - DNA extraction Cytology samples; Formalin-fixed paraffin-embedded (FFPE) tissues DNA storage for future analyses; Quantification of DNA; Sample assessment and identification; Viable DNA; Viable DNA for sequencing
Molecular genetics - DNA sequencing Extracted DNA DNA sequence analysis; DNA sequencing reaction purification step; Sequenced DNA utilising massively parallel sequencing technologies
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changes Cytology samples; Formalin-fixed paraffin-embedded (FFPE) tissues Solid tumours
Molecular genetics - RNA extraction Cytology samples; Formalin-fixed paraffin-embedded (FFPE) tissues Quantification of RNA; Sample assessment and identification; Viable RNA; Viable RNA for molecular diagnostics; Viable RNA for sequencing
Molecular genetics - RNA sequencing Extracted RNA RNA sequence analysis; RNA sequencing reaction purification step; Sequenced RNA utilising massively parallel sequencing technologies
Molecular genetics/Cytogenetics - Bioinformatic analysis VCF files Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and copy number analysis; Tertiary analysis - Data annotation and interpretation

ISO 15189 (2022)

  • This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.

Human Pathology

Medicare expiry date

28 Feb 2027

Last Activity Date

09 Aug 2022

Service Product Determinant
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes Blood; Extracted DNA Calcium sensing receptor (CaSR gene mutation); Hyperparathyroidism - Jaw tumour syndrome; Medullary thyroid cancer (RET gene mutation); Multiple endocrine neoplasia type 2 (MEN2); Nucleic acid analysis for specific variants; Parathyroid hormone (PTH); Sporadic and inherited neuroendocrine syndromes - Phaeochromocytomas and paragangliomas - SDHD,B,C,A TMEM127, fumarate hydratase, MAX gene mutations; Thyroid hormone receptor (THRB gene mutation); Thyroid stimulating hormone receptor (TSHR); Vitamin D 24-hydroxylase; Von Hippel Lindau disease
Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Blood; Formalin-fixed paraffin-embedded (FFPE) tissues Somatic RET for medullary thyroid carcinoma (variant and loss of heterozygocity)
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted panels for inherited (germline) DNA/RNA changes Blood; Extracted DNA Hyperparathyroidism - Jaw tumour syndrome; Parathyroid hormone (PTH); Thyroid stimulating hormone receptor (TSHR); Vitamin D 24-hydroxylase
Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Molecular genetics - Heterozygous loci determinations Blood; Extracted DNA Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes Blood; Extracted DNA Hyperparathyroidism - Jaw tumour syndrome; Parathyroid hormone (PTH); Thyroid stimulating hormone receptor (TSHR); Vitamin D 24-hydroxylase
Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Calcium sensing receptor (CaSR gene mutation); Medullary thyroid cancer (RET gene mutation); Multiple endocrine neoplasia type 2 (MEN2); Nucleic acid analysis for specific variants; Sporadic and inherited neuroendocrine syndromes - Phaeochromocytomas and paragangliomas - SDHD,B,C,A TMEM127, fumarate hydratase, MAX gene mutations; Von Hippel Lindau disease
Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted panels for inherited (germline) DNA/RNA changes Blood; Extracted DNA Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes Blood; Extracted DNA Calcium sensing receptor (CaSR gene mutation); Hyperparathyroidism - Jaw tumour syndrome; Medullary thyroid cancer (RET gene mutation); Multiple endocrine neoplasia type 2 (MEN2); Nucleic acid analysis for specific variants; Parathyroid hormone (PTH); Sporadic and inherited neuroendocrine syndromes - Phaeochromocytomas and paragangliomas - SDHD,B,C,A TMEM127, fumarate hydratase, MAX gene mutations; Thyroid hormone receptor (THRB gene mutation); Thyroid stimulating hormone receptor (TSHR); Von Hippel Lindau disease
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted panels for inherited (germline) DNA/RNA changes Blood; Extracted DNA Hyperparathyroidism - Jaw tumour syndrome; Parathyroid hormone (PTH); Thyroid stimulating hormone receptor (TSHR); Vitamin D 24-hydroxylase
Calcium sensing receptor (CaSR gene mutation); Medullary thyroid cancer (RET gene mutation); Multiple endocrine neoplasia type 2 (MEN2); Nucleic acid analysis for unknown variants; Sporadic and inherited neuroendocrine syndromes - Phaeochromocytomas and paragangliomas - SDHD,B,C,A TMEM127, fumarate hydratase, MAX gene mutations; Thyroid hormone receptor (THRB gene mutation); Von Hippel Lindau disease
Molecular genetics - Predictive genetic testing - Targeted genes Blood; Extracted DNA Calcium sensing receptor (CaSR gene mutation); Medullary thyroid cancer (RET gene mutation); Multiple endocrine neoplasia type 2 (MEN2); Nucleic acid analysis for specific variants; Sporadic and inherited neuroendocrine syndromes - Phaeochromocytomas and paragangliomas - SDHD,B,C,A TMEM127, fumarate hydratase, MAX gene mutations; Thyroid hormone receptor (THRB gene mutation); Von Hippel Lindau disease
Hyperparathyroidism - Jaw tumour syndrome; Thyroid stimulating hormone receptor (TSHR); Vitamin D 24-hydroxylase
Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Molecular genetics - Predictive genetic testing - Targeted panels for inherited (germline) DNA/RNA changes Blood; Extracted DNA Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Molecular genetics - Screening for an unknown mutation - Targeted genes Blood; Extracted DNA Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Calcium sensing receptor (CaSR gene mutation); Medullary thyroid cancer (RET gene mutation); Multiple endocrine neoplasia type 2 (MEN2); Nucleic acid analysis for unknown variants; Sporadic and inherited neuroendocrine syndromes - Phaeochromocytomas and paragangliomas - SDHD,B,C,A TMEM127, fumarate hydratase, MAX gene mutations; Thyroid hormone receptor (THRB gene mutation); Von Hippel Lindau disease
Hyperparathyroidism - Jaw tumour syndrome; Parathyroid hormone (PTH); Thyroid stimulating hormone receptor (TSHR); Vitamin D 24-hydroxylase
Molecular genetics - Screening for an unknown mutation - Targeted panels for inherited (germline) DNA/RNA changes Blood; Extracted DNA Calcium sensing receptor (CaSR gene mutation); Medullary thyroid cancer (RET gene mutation); Multiple endocrine neoplasia type 2 (MEN2); Nucleic acid analysis for unknown variants; Sporadic and inherited neuroendocrine syndromes - Phaeochromocytomas and paragangliomas - SDHD,B,C,A TMEM127, fumarate hydratase, MAX gene mutations; Von Hippel Lindau disease
Hyperparathyroidism - Jaw tumour syndrome; Paragangliomas; Von Hippel Lindau disease
Hyperparathyroidism - Jaw tumour syndrome; Parathyroid hormone (PTH); Thyroid stimulating hormone receptor (TSHR); Vitamin D 24-hydroxylase

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.