In vitro

Designed for in vitro diagnostic use in the European Union, the kit is used for next-generation sequencing (NGS), allowing to detect rearrangements involving the ALK, ROS-1, RET and NTRK1 genes from as little as 10ng of RNA.

Thermo Fisher Scientific oncology general manager and vice-president Mike Nolan said: "This latest kit enables our clinical customers to detect multiple genetic rearrangements from each tumor 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."

The target content is said to focus more on lung cancer and is also applicable for other solid tumors. 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.

According to the company, current approaches to detect numerous variations in a clinical laboratory depend on the use of multiple tests, each developed to detect a different genetic rearrangement.

Significant risk of the tumor sample being consumed before an actionable variant is uncovered, when used in a sequential manner with other required pathology tests.

The new kit overcomes this problem with its low RNA sample input requirement of FFPE tissue (10ng extracted nucleic acid per reaction), providing crucial information to a greater number of patients and beneficial insight that can help in guiding treatment.

Image: Thermo Fisher Scientific headquarters in Waltham. Photo: courtesy of Coolcaesar.