What is the POLARIS Droplet Digital PCR (ddPCR) EGFR Mutation Test?
The POLARIS Droplet Digital PCR (ddPCR) EGFR Mutation Test for Lung Cancer is a Laboratory-Developed Test (LDT) developed by the POLARIS Laboratory at Genome Institute of Singapore (POLARIS@GIS) that indicates the mutation status of key actionable EGFR mutations in non-small cell lung carcinoma (NSCLC) patients. It utilizes the highly sensitive ddPCR technology which partitions blood-derived cell-free DNA (cfDNA) or formalin-fixed paraffin-embedded (FFPE)-derived genomic DNA (gDNA) samples into discrete oil droplets that are subsequently analysed to determine whether a sample is positive for the tested mutation(s).
How will the POLARIS ddPCR EGFR Mutation Test results affect treatment for lung cancer patients?
The POLARIS ddPCR EGFR Mutation Test examines the presence of key actionable EGFR mutations which are relevant in predicting patient response to EGFR Tyrosine Kinase Inhibitor (TKI) treatment, and monitoring of residual or recurrent disease. Its cell-free DNA (cfDNA) testing option provides a less invasive means of testing. Detection of tumour-associated mutations in cfDNA may precede detection of recurrent disease via conventional radiological methods, allowing for early intervention. POLARIS ddPCR EGFR Mutation Test has a better Limit-of-Detection (LoD) than conventional sequencing-based assays, and clinical reports are available within 4 working days from sample acceptance.
How are patients assured of the quality of the POLARIS ddPCR EGFR Mutation Test?
The POLARIS ddPCR EGFR Mutation Test was developed and validated in accordance with the College of American Pathologists (CAP) guidelines, within the CAP-accredited POLARIS Laboratory at Genome Institute of Singapore (POLARIS@GIS). A clinical report is issued to indicate the detection status of tested mutations, and to provide clinical interpretation of detected mutations.
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