New FFPE RNA Reference Standards Launched

Horizon Discovery Group plc announces the launch of HDx™ FFPE RNA Fusion Reference Standards, independent analytical controls for the optimisation and validation of targeted RNA-seq, endpoint RT-PCR or RT-qPCR assays.

This product class is being initially established through the launch of ALK-RET-ROS1 targeted FFPE RNA Fusion Reference Standards.  These standards are highly-characterised, biologically-relevant, quality control material used to assess the performance of targeted NGS, RT-PCR and RT-qPCR assays aimed at detecting gene fusions. Each section contains a formalin-fixed, paraffin-embedded (FFPE) cell line multiplex verified to contain EML4-ALK (Variant 1), CCDC6-RET and SLC34A2-ROS1 fusions.

ALK fusions of the genetic markers ALK, RET and ROS1 are found in approximately 3–7% of lung tumours and are an important clinical marker for non-small cell lung cancer. The anti-cancer drug Crizotinib, marketed by Pfizer, acts as an ALK and ROS1 inhibitor and is approved to treat certain late-stage non-small cell lung cancers that express the abnormal anaplastic lymphoma kinase (ALK) gene, alongside an approved companion diagnostic.  It is therefore essential to have accurate and reliable molecular diagnostic testing prior to beginning therapy.

These FFPE RNA Reference Standards allow end users to evaluate the integrity of their workflow from pre-analytical RNA extraction through to fusion detection, enabling them to optimise and validate targeted RNA fusion panels.  The cell lines employed in the generation of these standards provide a renewable source of reference material that is reproducible and consistent, being manufactured under ISO 9001.

Dr Paul Morrill, President, Products Business, Horizon Discovery Group, said: “Laboratories often struggle to find renewable sources of reference material for rarer genetic profiles, and so we are pleased to be able to address this area of significant need.”

He continued: “The launch of these RNA-based Reference Standards further demonstrates our leadership, expanding our capabilities into emerging areas where the use of highly characterised and precisely engineered controls promises to have significant impact for our customers.  They now enable users to evaluate their workflow integrity from pre-analytical RNA extraction through to fusion detection, and to optimise, validate and routinely monitor assay performance of existing and future targeted RNA panels.”