Meridian’s Molecular Solution for Oncology Diagnostic Assays
biological fluids (e.g. blood, urine, saliva and stool) to test for cancer biomarkers have emerged as a more accurate, less expensive, and minimally invasive method. They are increasingly being used for cancer profiling, however due to the low abundance of the biomarker in the biological sample, a sensitive and specific technology must be used for analysis to prevent false negative results. NGS vs qPCR for Liquid Biopsy The primary techniques used for liquid biopsy analysis are qPCR and next-generation sequencing (NGS), and each has its own advantages and disadvantages. qPCR is known for its high sensitivity and specificity, allowing for the precise quantification of specific DNA sequences. It is a rapid and cost-effective method, suitable for detecting known mutations. NGS offers a more comprehensive analysis of the entire genomic landscape, allowing for the simultaneous detection of various mutations across multiple genes. NGS is particularly valuable for identifying rare mutations and uncovering broader genomic alterations. However, it tends to be more resource-intensive and time-consuming and may have higher associated costs compared to qPCR. The choice between qPCR and NGS depends on the specific goals of the liquid biopsy analysis, such as the need for targeted mutation detection versus comprehensive genomic profiling. Both techniques can be utilized in high-throughput platforms for large scale-screening, allowing for the efficient analysis of numerous samples in parallel. Or they can be adapted to point-of-care applications that bring diagnostic capabilities closer to the patient.
Meridian’s molecular chemistries support cancer testing with innovative qPCR master mixes. We have developed specimen-specific formulations for blood, saliva, urine, and stool that are highly inhibitor- tolerant, and enable detection down to single copies of RNA or DNA. They can prevent carryover inhibitors from affecting assay results in workflows using extracted DNA or RNA, or they can be used to amplify DNA or RNA directly from crude samples, skipping the extraction step altogether. For genotyping assays, our genotyping specimen-specific mixes provide clear allelic discrimination and cluster resolution, ideal for difficult SNPs. All of these specimen-specific master mixes are glycerol-free and formulated for air-drying or lyophilization, enabling the downstream flexibility to create ambient-temperature stable assays that do not require cold chain shipping and storage. The future of cancer testing is heading towards improved access, driven by technological advancements and innovative healthcare delivery models. New point-of-care testing solutions that prioritize accessibility, inclusivity and sustainability are sought after to address the inequality in cancer care across geographic, socioeconomic, cultural, and economic backgrounds. Meridian’s air-dryable and lyophilization-ready master mixes present a novel solution, eliminating the necessity for cold-chain shipment and storage which can restrict access to critical diagnostic tools, particularly in resource-limited settings. By democratizing access to cancer testing through innovative point-of-care solutions, Meridian hopes to promote equitable access to timely and effective cancer testing, leading to improved outcomes and ultimately, a reduction in the global burden of cancer. #closethegap
Inhibitor tolerance is a key factor in improving assay sensitivity as it minimizes the negative impact of inhibitory substances found in complex biological samples. Overall, master mixes that have high inhibitor tolerance increase the robustness of the amplification, which is particularly important in oncology testing that aim to detect low-abundance DNA and RNA targets such as point mutations, ctDNA, and lncRNA. Antibody hot start technologies are combined with the latest advances in PCR enzymatic systems to result in master mixes that provide high sensitivity and robustness, even when using crude samples or when the conditions are suboptimal due to the presence of carry-over inhibitors. High inhibitor-tolerance with ultra-sensitive detection
Maximizing Sensitivity - Detection Down to a Single Copy
We demonstrated that by air-drying MDX092 (Air-Dryable Direct DNA qPCR Blood) and maximising sample volume we could achieve sensitivity down to a single copy of an EGFR Exon 19 deletion (Figure 1).
Figure 1. MDX092 - Comparison of Sensitivity & Sample Volume. Plasma extract was spiked with synthetic template that incorporated an EGFR exon 19 deletion. The maximum sample volume that could be used with Roche Kapa Probe Force was 45% in a wet reaction. MDX092 was air-dried with primers and probe and therefore could be reconstituted in 100% of template.
MDX092 - EGFR Ex19 Deletion, 1 copy MDX092 - EGFR Ex19 Deletion, 10 copies MDX092 - EGFR Ex19 Deletion, 100 copies
Roche Kapa Probe Force - EGFR Ex19 Deletion, 1 copy Roche Kapa Probe Force - EGFR Ex19 Deletion, 10 copies Roche Kapa Probe Force - EGFR Ex19 Deletion, 100 copies
www.meridianbioscience.com/lifescience
Powered by FlippingBook