Horizon Discovery Group plc and ArcherDX, Inc. have announced that they have signed an Original Equipment Manufacture (OEM) agreement that will see Horizon’s Reference Materials supplied as a standalone product alongside ArcherDX’s Archer™ FusionPlex™ to aid customer validation of its ALK fusion assay kits.
The agreement is a further endorsement of the demand in the translational sequencing market for accurate and reliable reference material to validate sample testing. Horizon’s reference materials will be available for sale alongside Archer™ FusionPlex™ ALK fusion tests that can run on both Illumina® and Ion Torrent™ next-generation sequencing platforms, a fast-growing market that represented $2.5 billion in 2014 and Horizon anticipates that the Archer assay will prove to be well received by the market. Further financial details of the deal were not disclosed.
The Archer™ FusionPlex™ ALK, RET, ROS1 Panel simultaneously detects and identifies both known and previously unidentified fusions and mutations of human ALK, RET and ROS1 (c-ros oncogene 1) genes from tumour samples, including formalin fixed paraffin embedded (FFPE) preserved specimens.
ALK fusions of genetic markers ALK, RET, 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.
Horizon’s Reference Materials offer a high quality, sustainable source of independent external controls to laboratories, proficiency schemes and manufacturers, providing an unprecedented level of control. The reference materials include standards for the increasing number of ‘rare’ mutations being targeted for cancer therapeutics, which by definition are hard to find in clinical samples.
Dr Paul Morrill, President, Products Business, Horizon Discovery Group, said: “Our agreement with Archer is a recognition of the importance of providing controls alongside a targeted sequencing assay, and as an important OEM agreement is a milestone for Horizon. We are delighted that ArcherDX has chosen to include our HDx Reference Material alongside their assay kits.”
Dr Jason Myers, CEO of ArcherDX, commented: “The three genes in this particular FusionPlex assay can be oncogenic drivers in lung cancer, which makes them great candidates for targeted therapies. The low incidence rates of these mutations make it difficult for laboratories to find renewable sources of controls. By combining HDx Reference Material with the Archer panel, we are able to offer a method to ensure consistency and accuracy.”