Laboratory Services – Malaysia

Intended Use: To detect mutations in the FGFR gene, as an aid in identifying urothelial cancer patients that may benefit from FGFR-targeted therapy.

• Test Code: PH-FGFR
• Turnaround Time: 10 working days
• Sample Type: 15 unstained slides with FFPE sections at 5µm thickness with minimum 20% tumour content

Intended Use: Detection of EWSR1 rearrangements in chromosome 22q12 to aid in the diagnosis of Ewing and Ewing-like small round cell sarcomas, as well as several other types of sarcoma.

• Test Code: PH-EWSR1
• Turnaround Time: 10 working days
• Sample Type: 6 unstained slides with FFPE sections at 5µm thickness

Intended Use: To determine MET amplification status in cancer, as an aid in prognostication and making therapeutic decisions.

• Test Code: PH-MET
• Turnaround Time: 10 working days
• Sample Type: 6 unstained slides with FFPE sections at 5µm thickness

Intended Use: To detect MGMT promoter methylation, in particular in gliomas, as an aid in prognostication and identifying patients that may benefit from treatment with temozolomide.

• Test Code: PH-MGMT
• Turnaround Time: 10 working days
• Sample Type: 15 unstained slides with FFPE sections at 5µm thickness with minimum 20% tumour content

Intended Use: A next generation sequencing (NGS)-based method to detect mutations in BRCA 1/2 genes as an aid in identifying cancer patients who may benefit from PARP inhibitors, in particular breast, ovarian, prostate, and pancreatic cancers.

• Test Code: PH-gBRCA
• Turnaround Time: 20 – 25 working days
• Sample Type: 2 x 6mL blood collected in K2EDTA tubes

Intended Use: A real time PCR method to determine microsatellite instability (MSI) status, as an aid in identification of probable Lynch syndrome, prognostication, and selection of cancer patients that may benefit from immunotherapy.

• Test Code: PH-MSI
• Turnaround Time: 10 working days
• Sample Type: 12 unstained slides with FFPE sections at 5µm thickness with minimum 20% tumour content

Intended Use: Standard health screening package covering blood and urine investigations

• Test Code: HSP 3.0
• Turnaround Time: 5 – 7 working days
• Sample Type: 5ml Blood in Serum Separating Tube, 3 ml blood in K2EDTA and 40 ml urine

Intended Use: Next generation sequencing panel covering 50 genes including ALK, BRAF, ERBB2 (HER2), EGFR, FGFR1/2/3/4, KIT, KRAS, MET, NRAS, NTRF1/2/3, PDGFRA, PIK3CA, RET, ROS1

• Test Code: PH-APEX
• Turnaround Time: 8 – 10 working days
• Sample Type: 20 unstained slides with FFPE sections at 5µm thickness with minimum 30% tumour content

Intended Use: Next generation sequencing panel covering 50 genes including ALK, BRAF, ERBB2 (HER2), EGFR, FGFR1/2/3/4, KIT, KRAS, MET, NRAS, NTRF1/2/3, PDGFRA, PIK3CA, RET, ROS1

• Test Code: PH-CODEX
• Turnaround Time: 8 – 10 working days
• Sample Type: 20 unstained slides with FFPE sections at 5µm thickness with minimum 30% tumour content

Intended Use: A next generation sequencing (NGS)-based method to detect mutations in BRCA 1/2 genes as an aid in identifying cancer patients who may benefit from PARP inhibitors, in particular breast, ovarian, prostate, and pancreatic cancers.

• Test Code: PH-BRCA
• Turnaround Time: 20 – 25 working days
• Sample Type: 20 unstained slides with FFPE sections at 5µm thickness with minimum 30% tumour content

Intended Use: A Sanger sequencing-based genotyping of up to 6 HLA loci (HLA-A, B, C, DQB1, DRB1, DPB1).

• Test Code: PH-HLA-001 (1 locus), PH-HLA-002 (2 loci), PH-HLA-003 (3 loci), PH-HLA-004 (4 loci), PH-HLA-005 (5 loci), PH-HLA-006 (6 loci)
• Turnaround Time: 20 – 25 working days
• Sample Type: 2 x 6mL blood collected in K2EDTA tubes

Intended Use: An in situ hybridization (ISH)-based method to determine HER2 gene status, in particular in breast or gastric cancers, as an aid in identifying patients who may benefit from trastuzumab.

• Test Code: PH-ISH-003
• Turnaround Time: 10 working days
• Sample Type: 6 unstained slides with FFPE sections at 5µm thickness

Intended Use: An in situ hybridzation (ISH)-based method to assess 1p and 19q deletion status to aid in diagnosis, prognostication and predicting therapeutic response of patients with diffuse gliomas, in particular oligodendrogliomas.

• Test Code: PH-ISH-002
• Turnaround Time: 7 – 10 working days
• Sample Type: 8-10 unstained slides with FFPE sections at 5µm thickness

Intended Use: A qualitative immunohistochemical detection of the programmed death ligand 1 (PD-L1) protein in triple-negative breast cancer, urothelial carcinoma, and non-small cell lung cancer to identify patients who may benefit from atezolizumab.

• Test Code: PH-IHC-004
• Turnaround Time: 10 working days
• Sample Type: 6 unstained slides with FFPE sections at 5µm thickness

Intended Use: A qualitative immunohistochemical detection of the mismatch repair proteins (MMR)- MLH1, PMS2, MSH2 and MSH6 to determine MMR status, as an aid in identification of probable Lynch syndrome and management of cancer, in particular colorectal and endometrial cancer.

• Test Code: PH-IHC-003
• Turnaround Time: 5 – 7 working days
• Sample Type: 10 unstained slides with FFPE sections at 5µm thickness

Intended Use: A qualitative immunohistochemical detection of the anaplastic lymphoma kinase (ALK) protein in non-small cell lung cancer  as an aid in identifying patients who may benefit from crizotinib, ceritinib, alectinib, or lorlatinib.

• Test Code: PH-IHC-002
• Turnaround Time: 5 – 7 working days
• Sample Type: 6 unstained slides with FFPE sections at 5µm thickness

Intended Use: A qualitative immunohistochemical detection of the programmed death ligand 1 (PD-L1) protein in gastric or gastroesophageal junction adenocarcinoma, cervical and urothelial carcinoma, triple-negative breast cancer, and head and neck squamous cell carcinoma to identify patients who may benefit from pembrolizumab.

• Test Code: PH-22C3
• Turnaround Time: 5 – 7 working days
• Sample Type: 6 unstained slides with FFPE sections at 5µm thickness

Intended Use: A qualitative immunohistochemical detection of the programmed death ligand 1 (PD-L1) protein in non-small cell lung cancer  to identify patients who may benefit from immunotherapy.

• Test Code: PH-IHC-001
• Turnaround Time: 5 – 7 working days
• Sample Type: 6 unstained slides with FFPE sections at 5µm thickness

Intended Use: A real-time PCR test that identifies mutations in exons 7, 9 and 20 of the PIK3CA gene

• Test Code: PH-PIK3CA
• Turnaround Time: 10 Working Days
• Sample Type: 10-12 unstained slides with FFPE sections at 5µm thickness with minimum 20% tumour content

Intended Use: To identify mutations in codon 12, 13, 59, 61, 117, and 146 of KRAS and NRAS gene to aid in the management of cancer patient, in particular colorectal cancer.

• Test Code: PH-TPCR-005
• Turnaround Time: 10 Working Days
• Sample Type: 15 unstained slides with FFPE sections at 5µm thickness with minimum 20% tumour content

Intended Use: A real-time PCR test that detects BRAF V600 mutations to guide therapeutic decisions in cancer patients, i.e., anti-EGFR therapy for colorectal cancer, TKI therapy for various cancers.

• Test Code: PH-TPCR-003
• Turnaround Time: 5 – 7 working days
• Sample Type: 10-12 unstained slides with FFPE sections at 5µm thickness with minimum 50% tumour content

Intended Use: To identify mutations in codon 12, 13, and 61 of the NRAS gene to guide therapeutic decisions in cancer patients.

• Test Code: PH-NRAS
• Turnaround Time: 10 Working Days
• Sample Type: 10-12 unstained slides with FFPE sections at 5µm thickness with minimum 20% tumour content

Intended Use: To identify mutations in codon 12, 13, and 61 of the KRAS gene to guide therapeutic decisions in cancer patients.

• Test Code: PH-KRAS
• Turnaround Time: 10 Working Days
• Sample Type: 10-12 unstained slides with FFPE sections at 5µm thickness with minimum 20% tumour content

Intended Use: A real-time PCR test that identify mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene as an aid in the management of non-small cell lung cancer patients.

• Test Code: PH-TPCR-001
• Turnaround Time: 5 – 7 Working Days
• Sample Type: 15 unstained slides with FFPE sections at 5µm thickness with minimum 10% tumour content

Intended Use: EarlyCDT-Lung is a rule-in test for lung cancer. It can be used for the detection of lung cancer early, when a patient is at risk of developing the disease due to a combination of age, gender, smoking history, and other risk factors such as environmental exposures (radon, asbestos, dust, radioactive substances).

The recommended guidelines for EarlyCDT-Lung testing are patients who are 50 years or older with a 20+ pack years smoking history, or those between the ages of 40-49 years with a 20+ pack years smoking history, and at least 1 additional risk factor. This test is not recommended for patients with a history of any type of cancer.

• Test Code: PH-ECDT
• Turnaround Time: 14 Working Days
• Sample Type: 3ml Blood in Plain Tube
• Sample Collection: Monday to Friday, between 8:30am to 2:00pm