Thermo Fisher Scientific has launched new CE-IVD Oncomine Solid Tumour Fusion Transcript kit, designed to provide multiplexed sequencing of formalin-fixed and paraffin embedded (FFPE) tumour samples.
Developed for in-vitro diagnostic use in the EU, the kit for next-generation sequencing (NGS) allows the detection of rearrangements involving the ALK, ROS-1, RET and NTRK1 genes from as little as 10ng of RNA.
The target content is focused more on lung cancer and is also applicable for other solid tumours, and it was verified with clinical researchers from the OncoNetwork Consortium present in ten different countries, who have experience in implementing NGS technologies in clinical laboratories.
Thermo Fisher Scientific oncology vice-president Mike Nolan said: "This latest kit enables our clinical customers to detect multiple genetic rearrangements from each tumour sample.
"When used with our previously released CE-IVD Oncomine Solid Tumour DNA kit, mutations can be identified simultaneously with fusion transcripts, all in a single streamlined procedure."
Genetic rearrangements that cause fusion transcripts are a major and expanding class of actionable biomarkers in cancer.
The company said that current approaches to detect many variations in a clinical laboratory depend on the use of multiple tests, each developed to detect a different genetic rearrangement.
The new kit helps to overcome the significant risk of the tumour sample being consumed before an actionable variant is uncovered.
With its low RNA sample input requirement of FFPE tissue (10ng extracted nucleic acid per reaction), the kit helps provide actionable information to a greater number of patients and beneficial insight that may help guide treatment.
Mr Nolan said: "The introduction of these two new CE-IVD products underscores our commitment to help our customers advance cancer care, while meeting the evolving local regulatory requirements."