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Oncology Clinical applications Precision Treatment Guidance
Clinical applications | Testing guidance

Precision Treatment Guidance

Connect tumor molecular findings to evidence for targeted therapies, immunotherapy, and drug resistance while accounting for cancer type and disease stage.

Clinical overview

Clinical purpose and scope

The objective is not simply to enumerate variants. Reports must indicate whether a biomarker has evidence for a specific tumor type and treatment line. DNA, RNA, IHC, and ISH tests can be complementary. Final therapeutic decisions rest with the treating team and the full clinical picture.

Assay selection notes

The listed assays are examples, not confirmed available services. Clinical indications, assay validation, and specimen requirements must be checked with the laboratory.

Scenario-based test selection

Tests to consider in different scenarios

Examples for discussion with an oncologist; test selection must reflect the clinical circumstances of each patient.

01

Advanced NSCLC before first-line therapy

Driver alteration status and PD-L1 expression are required to guide initial treatment.

Suggested assay or pathway

Validated comprehensive DNA/RNA profiling and PD-L1 IHC; plasma ctDNA may help if tissue is limited.

Rationale and caveats

Assess EGFR, ALK, ROS1, MET exon 14, RET, NTRK, BRAF and relevant additional targets. Negative plasma ctDNA does not rule out the need for tissue testing.

02

Metastatic colorectal cancer

The team must determine eligibility for or resistance to selected targeted regimens.

Suggested assay or pathway

Tumor RAS/RAF assessment, MSI/MMR status, and appropriate additional biomarkers based on the intended regimen.

Rationale and caveats

Specific KRAS, NRAS and BRAF variants and tumor sidedness may change interpretation; assay results require disease-specific context.

03

Ovarian or breast cancer with DNA-repair biomarkers

Eligibility for DNA-repair-directed treatment may be relevant in a defined clinical setting.

Suggested assay or pathway

Appropriate BRCA1/2 germline/tumor testing and, where indicated, a validated HRD assay.

Rationale and caveats

A pathogenic BRCA result and a genomic scar score are different findings; interpretation depends on indication and treatment history.

04

Immunotherapy decision in an advanced solid tumor

The treating team is considering checkpoint blockade and needs biomarker context.

Suggested assay or pathway

Use the indicated PD-L1 assay, MSI/MMR testing, and selected TMB testing when supported by the cancer type and regulatory indication.

Rationale and caveats

No single marker predicts immunotherapy benefit across every cancer or regimen; use disease-specific criteria.

Related assays

Related assays and their uses

Each entry specifies the sample, testing goal, and clinical context to avoid confusion.

Tumor CGPValidated, indication-dependent

Comprehensive tumor DNA/RNA NGS

Broad profiling for drivers and resistance changes in eligible tumors

Specimen / data: Tumor tissue
RNA Fusion NGSIndication dependent

Targetable RNA fusion panel

Detect therapeutically relevant fusions including ALK, ROS1, RET and NTRK

Specimen / data: Tumor tissue / RNA
Plasma ctDNA ProfilingIndication dependent

Plasma ctDNA profiling

Molecular testing when tumor tissue is limited or at progression

Specimen / data: Blood plasma
PD-L1 IHCValidated IHC

PD-L1 immunohistochemistry

Assess PD-L1 expression for relevant immune checkpoint indications

Specimen / data: FFPE tissue
MSI / MMR IHCValidated IHC/PCR/NGS

MSI/MMR assessment

Determine mismatch-repair status for selected treatments

Specimen / data: Tumor tissue
HER2 IHC/ISH · ER/PRValidated IHC/ISH

HER2 and hormone receptor assays

Assess HER2 and ER/PR for applicable tumor types

Specimen / data: Tumor tissue
HRD / Tumor & Germline BRCAIndication dependent

HRD and BRCA evaluation

Evaluate homologous recombination repair biomarkers in applicable settings

Specimen / data: Tumor or germline as appropriate
TMBSelected indications

Tumor mutational burden (TMB)

Quantify mut/Mb using a validated method when clinically indicated

Specimen / data: Adequate tumor DNA
Before ordering

Required information and expected report

Define the relevant clinical information and expected report components before discussing testing with the scientific team.

Required inputs

Cancer subtype, stage, previous therapies, and current clinical intent

Prior biomarker results, pathology, and sample suitability

Relevant drug access and guideline context for the treatment setting

Expected reporting elements

Actionable alterations and evidence contextualized by cancer type and indication

Method and analytic limitations, especially negative liquid biopsy findings

Recommendations for additional testing or multidisciplinary molecular review as appropriate

Interpretation and evidence

Interpretation and limitations

• The same variant may have different evidence levels across cancer types and lines of therapy.

• A negative liquid biopsy result may require reflex tissue testing because of low tumor DNA shedding.

• Companion diagnostic requirements, validated cutoffs, and current local approvals must be checked before treatment selection.

Need guidance on choosing an appropriate test?

Describe the clinical question and available data in the support form; do not send patient identifiers.

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