From Sample to Insight: Technologies Driving the Future of Precision Oncology Assays
With more than 68 FDA-approved tests ( Table 2 ), qPCR-based companion diagnostics have become a cornerstone of precision oncology. Their ability to rapidly and sensitively detect clinically actionable mutations, often at levels matching or surpassing standard NGS (typically 0.5–2% VAF, unless using ultra-deep or error-corrected methods), makes them ideal for focused, mutation-specific applications. qPCR Sensitivity Overview: • Limit of detection (LOD): Reliably detects as few as 1–10 mutant copies among 10,000+ wild-type molecules • Variant allele frequency (VAF): Capable of identifying mutations at frequencies as low as 0.1% These same performance advantages, ultra-low detection limits, high specificity, and fast turn- around, make qPCR especially well-suited for longitudinal monitoring, such as minimal residual
disease (MRD) tracking and early recurrence detec- tion via liquid biopsy. As oncology moves toward more adaptive, biomarker-driven care models, qPCR will remain a vital tool for enabling timely, data-guided treatment decisions.
Rapid Turnaround Time & Compatibility with Automation
Unlike sequencing-based methods that can take days to deliver and interpret results, qPCR provides clinically actionable answers within hours. This speed is especially critical for time-sensitive deci- sions, such as determining eligibility for targeted therapies or enrolling patients in biomarker-driven trials. Just as importantly, qPCR workflows are automation-friendly and require minimal hands-on time—enabling high-throughput testing without sacrificing turnaround. Together, these attributes make qPCR an ideal choice for integrated care settings, where rapid, scalable diagnostics are essential for timely intervention.
Table 2. Examples of FDA-cleared qPCR precision oncology assays used in clinical practice.
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