From Sample to Insight: Technologies Driving the Future of Precision Oncology Assays
Meridian evaluated performance of its Lyo-Ready™ Genotyping Direct qPCR FFPE mix in both liquid and lyophilized formats across a 10-fold dilution series (1,000 to 1 copy) in the presence of 20% extraction buffer—mimicking typical FFPE condi- tions. Both formats demonstrated comparable sensitivity and reproducibility, confirming that the lyophilized formulation retains full performance even under inhibition pressure ( Figure 1 ). • Ambient-Temperature Stable Assays Lyophilized or air-dried assays that are stable at ambient temperature eliminate cold-chain requirements, enable room-temperature shipping and storage, and maintain consistent performance across diverse climates and infrastructure settings. These formats reduce logistical complexity and enable reliable global deployment which is crucial for expanding access to precision diagnostics.
Diagnostic manufacturers often produce reagents centrally and distribute them globally, with many products requiring cold-chain shipping and storage to maintain integrity. Lyophilized diagnostics offer an alternative, with extended shelf life, reduced waste, and lightweight, compact formats that simplify shipping. While lyophilization involves an upfront cost, it can deliver substantial freight savings and lower environmental impact, with cost reductions ranging from 8% to 43% depending on shipping needs. 8 • Fast-Cycling and Direct Detection Protocols Protocols that leverage rapid thermal cycling using enzymes with high processivity reduce instrument runtime, while direct detection proto- cols that bypass nucleic acid extraction help streamline the workflow, minimize sample loss, and further shorten the time-to-result ( Figure 2 ).
Figure 1. qPCR amplification of synthetic DNA in liquid (blue) and lyophilized (red) Lyo-Ready™ Genotyping Direct qPCR FFPE mix. A 10-fold dilution series (1,000 to 1 copy) was tested in the presence of 20% MDx16B Extraction Buffer. Both formats demonstrated comparable sensitivity and reproducibility, confirming that the lyophilized formulation maintains equivalent performance across low target inputs—even in challenging clinical conditions.
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