Precision Oncology & NGS

Genomic testing does not guarantee an actionable alteration, a treatment option, treatment response or an improved outcome. Molecular information complements — it does not replace — conventional cancer diagnosis, pathology and clinical assessment.

The question a patient asks after a diagnosis — “What else can I do?” — becomes, for the clinical team, a set of more specific questions: What else do we need to understand? What information could genomic testing add? The answers are not automatic. They move through a testing strategy, a result with interpretation, and finally back into an informed clinical discussion.

Every step adds information. None of them, alone, decides treatment — that remains a clinical discussion.

A cancer diagnosis is traditionally built from clinical findings, imaging and pathology — the anatomical site, histological type and grade. Molecular profiling can add a further layer: information about the DNA and RNA of the tumour that sits alongside these established assessments.

Depending on the assay design, DNA analysis may detect relevant sequence variants, copy-number changes and other genomic alterations. RNA analysis can provide complementary information, particularly for selected fusion and transcript events that DNA sequencing alone may not fully capture.

For some cancers, a focused set of genes answers the clinical question. For others — for example sarcomas, where translocation events are central to classification — RNA-based fusion analysis is specifically informative. Comprehensive genomic profiling is one option among several, not a default.

Molecular findings must be interpreted in the context of the disease and the individual clinical situation. Not every patient requires comprehensive genomic profiling, and the choice of assay should follow the clinical and molecular question being asked.

• DNA SEQUENCING
• RNA SEQUENCING
• FUSION ANALYSIS
• COMPREHENSIVE GENOMIC PROFILING

Genomic testing may identify biomarkers — but a detected alteration is not automatically an actionable one. Clinical actionability depends on the strength of evidence linking a specific molecular finding to a specific treatment benefit, in a specific cancer type.

International frameworks such as the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) organise this evidence into levels, from alterations that are standard-of-care targets in a given cancer, down to findings whose relevance is uncertain. The level of evidence matters as much as the finding itself.

More genes is not automatically better testing. Larger panels detect more alterations, including more of uncertain significance, and the appropriate test is the one designed around the clinical question — not the largest one available.

Molecular information can come from the tumour itself, or from tumour-derived DNA released into the bloodstream. These are two different routes to similar questions, and they are complementary rather than competing.

Neither approach is universally superior. Which to use — or whether to use both — depends on the cancer, the clinical setting, the specimen availability and the question being asked.

After curative-intent treatment for some solid tumours, very low levels of tumour-derived DNA in the blood can, in appropriate settings, provide molecular evidence of residual disease — before it is visible on imaging. This is molecular residual disease, or MRD, monitoring.

MRD is not an ordinary off-the-shelf panel. It is a personalised, longitudinal molecular workflow: the tumour is first characterised, patient-specific molecular information is extracted from that profile, and a personalised tracking assay is developed for that individual patient. Blood drawn at a landmark time point — typically post-surgery — establishes the baseline, and subsequent blood draws monitor that signature over time.

Across multiple tumour types, post-treatment detection of ctDNA has demonstrated prognostic significance and has been associated with increased risk of recurrence. That is clinical validity. Whether changing treatment based on an MRD result improves clinical outcomes — clinical utility — is a separate question, and MRD-directed treatment decisions are not yet a universally established standard of care. MRD monitoring complements, and does not replace, imaging, pathology and standard clinical surveillance.

A personalised workflow, not a catalogue product: the tracking strategy is built for one patient.

Precision oncology questions follow the patient’s journey. At diagnosis: what is this cancer, molecularly? During treatment planning: which biomarkers could inform the discussion? During and after treatment: what can we monitor? Each stage has its own question, and its own appropriate testing strategy.

Accuflex works with Genecast to make these testing strategies available in Malaysia. The portfolio below is organised by the question each service helps address — not by panel size. A focused question may be answered by focused profiling; a broader molecular question may warrant comprehensive profiling. Neither is automatically better — the test follows the question.

Both routes are supported end-to-end by Accuflex.

Beyond sample logistics, Accuflex supports laboratories seeking to establish selected molecular testing capabilities locally.

— with Accuflex supporting the appropriate pathway. Depending on the assay and implementation model, support may include:

• Product / Application Consultation
• Workflow Evaluation
• Implementation Planning
• Installation
• Training
• Method Implementation
• Technical Support
• Troubleshooting
• Ongoing Reagent Supply
• Workflow Support

Our role is to help each laboratory choose the testing strategy that fits its clinical question, its workload and its operating model.