The Oncomine™ Precision Assay

What is the Oncomine™ Precision Assay?

Advanced Next-Generation Sequencing (NGS) Panel

• Designed for comprehensive tumour profiling.
• Includes all relevant and emerging biomarkers in precision oncology.

Genes Included in the Assay
DNA Hotspots:

• AKT1, AKT2, AKT3, ALK, AR, ARAF, BRAF, CDK4, CDKN2A, CHEK2, CTNNB1, EGFR, ERBB2, ERBB3, ERBB4, ESR1, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, GNA11, GNAQ, GNAS, HRAS, IDH1, IDH2, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, NTRK1, NTRK2, NTRK3, PDGFRA, PIK3CA, PTEN, RAF1, RET, ROS1, SMO, TP53.

Copy Number Variants (CNVs):

• ALK, AR, CD274, CDKN2A, EGFR, ERBB2, ERBB3, FGFR1, FGFR2, FGFR3, KRAS, MET, PIK3CA, PTEN.

Fusions:

• ALK, AR, BRAF, EGFR, ESR1, FGFR1, FGFR2, FGFR3, MET, NRG1, NTRK1, NTRK2, NTRK3, NUTM1, RET, ROS1, RSPO2, RSPO3.

The Oncomine™ Precision Assay provides an extensive molecular profile of solid tumours, enabling targeted therapy selection.

Why Choose the Oncomine™ Precision Assay Over Other Panels?

Advantages Over EGFRASSEQ Solid Tumour Panel

Expanded Profile:

• Detects 2769 unique variants compared to 10 genes in EGFRASSEQ.
• Covers mutations, copy number variants (CNVs), and fusion genes across 50 key genes.

Lower Sample Requirements with Higher Sensitivity:

• Requires only 10 ng of DNA (~3000 cells) or RNA.
• Produces sequencing results in >95% of samples.

Faster Turnaround Time for Clinical Impact:

• Uses the Ion Torrent Genexus™ System for rapid results.
• Expected turnaround time: 7–10 working days.

Cost Savings:

• More cost-effective than multiple single-gene PCR assays.

The Oncomine™ Precision Assay delivers faster, more accurate, and cost-efficient tumour profiling.

How to Request Oncomine™ Precision Assay Testing

Test Ordering Process

1. Contact the relevant histopathology laboratory where the case was reported.
2. Request OPANGS (Oncomine Precision Assay).
3. For Discovery Health patients, a pre-authorization code is required:
   • OPALUNG (for lung tumours).
   • OPACOL (for colorectal tumours).

Turnaround Time

• 7–10 working days.

Ampath offers seamless ordering and quick results for precision oncology testing.

Oncomine™ Precision Assay vs. Focus Assay

What Makes Oncomine™ Precision Assay an Evolution of the Focus Assay?
1. Updated Gene List

• Covers future targeted therapies and novel fusion isoforms.

2. Includes Resistance Mutations

• Detects 218 potential resistance mutations.

3. Liquid Biopsy Compatibility

• Can be used on circulating tumour DNA (ctDNA) from plasma samples.

The Oncomine™ Precision Assay is an improved and more comprehensive solid tumour profiling solution.

Precision Oncology: Matching Tumour Biomarkers to Targeted Therapies

DA-Approved Targeted Therapies Matched to Biomarkers

Breast Cancer:

• ERBB2 (HER2) amplification → Trastuzumab (Herceptin®), Ado-trastuzumab-emtansine (Kadcyla®), Pertuzumab (Perjeta®).
• PIK3CA mutation → Alpelisib (Piqray®).

Colorectal Cancer:

• BRAF V600E mutation → Encorafenib (Braftovi®) + Cetuximab (Erbitux®).
• KRAS wild-type → Cetuximab (Erbitux®), Panitumumab (Vectibix®).

Cholangiocarcinoma:

• FGFR2 fusions → Pemigatinib (Pemazyre™), Infigratinib (Truseltiq™).

Gastrointestinal Stromal Tumour (GIST):

• KIT mutations → Imatinib (Gleevec™).

Melanoma:

• BRAF V600E → Dabrafenib (Tafinlar®), Vemurafenib (Zelboraf®).
• BRAF V600E/V600K → Trametinib (Mekinist®), Cobimetinib (Cotellic®).

Non-Small Cell Lung Cancer (NSCLC):

• ALK rearrangement → Alectinib (Alecensa®), Brigatinib (Alunbrig®), Crizotinib (Xalkori®), Ceritinib (Zykadia®).
• BRAF V600E → Dabrafenib (Tafinlar®) + Trametinib (Mekinist®).
• EGFR mutations (Exon 19, Exon 21 L858R) → Osimertinib (Tagrisso®), Erlotinib (Tarceva®), Gefitinib (Iressa®), Afatinib (Gilotrif®).
• KRAS G12C mutation → Sotorasib (Lumakras™).
• MET alterations → Capmatinib (Tabrecta®).
• RET alteration → Pralsetinib (Gavreto®), Selpercatinib (Retevmo®).
• ROS1 rearrangement → Crizotinib (Xalkori®), Entrectinib (Rozlytrek®).

Solid Tumours:

• NTRK1/2/3 fusions → Larotrectinib (Vitrakvi®), Entrectinib (Rozlytrek®).

Thyroid Cancer:

• RET alteration → Pralsetinib (Gavreto®).
• BRAF V600E → Dabrafenib (Tafinlar®) + Trametinib (Mekinist®).

Urothelial Cancer:

• FGFR2/3 alterations → Erdafitinib (Balversa®).

Oncomine™ Precision Assay provides key biomarker insights to match patients with the most effective targeted therapies.

Contact Information

For Test Requests & Further Information

• Ampath NGS Laboratory: 012 678 0645
• Email: ngs@ampath.co.za

he Oncomine™ Precision Assay offers a powerful and comprehensive tumour profiling solution, bringing precision oncology closer to routine clinical practice.