The Archer FusionPlex ALK, RET, ROS1 Panel simultaneously detects and identifies both known and previously unidentified fusions and mutations of human ALK (anaplastic lymphoma kinase), RET and ROS1 (c-ros oncogene 1) genes from tumour samples, including FFPE (formalin fixed paraffin embedded) preserved specimens.
The reference materials include standards for the increasing number of rare mutations being targeted for cancer therapeutics, which are difficult to find in clinical samples.
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. Pfizer’s cancer drug Crizotinib 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, which is why it’s necessary to have accurate and reliable molecular diagnostic testing prior to beginning therapy.
Sequencing service companies, molecular pathology labs, hospitals, universities, NIH (National Institutes of Health), pharma companies, and diagnostic kit/device manufacturers are all prospective buyers of the new combination product.
Dr Jason Myers, CEO of ArcherDX, explained to Outsourcing-Pharma.com the importance of this collaboration: “Until now, customers would have to test and validate three different control samples in order to identify three different positives. Customers use a variety of sources for controls, but all of them have their limitations.
“For example, the commercially available FFPE [formalin fixed paraffin embedded] and frozen tissue samples we have used tend to be highly variable in quality, and are neither consistent from batch to batch, nor are they renewable. Furthermore, the extremely low frequency of ROS1 and RET-positive samples makes finding FFPE and other tissue almost impossible for the average lab.”
The agreement is a further endorsement of the demand in the translational sequencing market for accurate and reliable reference material to validate sample testing. The combination of the two companies’ products can run on both Illuminaand Ion Torrent NGS platforms, which are part of a $2.5bn market in 2014. Further financial details of the deal were not disclosed.