One of the most challenging issues involved in routine programs to control for process variability of molecular assays is the availability of reference material. For many less common forms of cancer, patient-derived samples may simply not be available, and in these cases plasmids or other forms of nucleic acid are used. End-to-end process control isn’t possible as the controls used can only represent what happens post-extraction. Additionally, synthetic reference standards such as oligonucleotides and plasmids tend to amplify more easily than equivalent template from cellular sources, which can create false confidence in molecular assay work flows.
Even if patient samples are available, allelic frequency is not uniform throughout, and the supply is not limitless. When a particular patient sample is no longer available, a new and potentially significantly different sample will be used, introducing another level of variability.
Horizon Diagnostics’ Reference Standards in contrast offer a reliable, consistent and continually renewable source of genetic material. Based on genomically engineered cell lines, mutant and wild type cells are mixed in precisely defined ratios. When provided in block or slide form, those ratios are uniform throughout. As HDx’ standards are generated from immortalized cell line stocks, researchers can be confident that the material they acquire from Horizon today will be the same as the one they previously received, and will be the same as the next one they order.
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