Thermo Fisher Scientific Releases New CE-IVD Fusion Transcript Kit for Next-Generation Sequencing

Thermo Fisher Scientific announced the release of the CE-IVD Oncomine Solid Tumour Fusion Transcript kit, a key solution designed to aid clinical-decision making and enable highly accurate and reliable multiplexed sequencing of formalin-fixed, paraffin embedded (FFPE) tumor samples.

Marked for in vitro diagnostic use in the European Union, the Oncomine Solid Tumour Fusion Transcript kit for next-generation sequencing (NGS) enables the detection of rearrangements involving the ALK, ROS-1, RET, and NTRK1 genes from as little as 10ng of RNA. The target content, focusing on lung cancer, but potentially applicable to other solid tumors, was verified with leading clinical researchers from the OncoNetwork Consortium spanning 10 different countries and with years of experience in implementing NGS technologies in clinical laboratories.

Genetic rearrangements that cause fusion transcripts are an important and expanding class of actionable biomarkers in cancer. Current approaches to detect numerous variations in a clinical laboratory rely on the use of multiple tests, each designed to detect a different genetic rearrangement. When used in a sequential manner with other required pathology tests, there is a significant risk of the tumor sample being consumed before an actionable variant is uncovered. The new kit overcomes this hurdle with its low RNA sample input requirement of FFPE tissue (10ng extracted nucleic acid per reaction), ultimately providing actionable information to a greater number of patients and beneficial insight that may help guide treatment.

“This latest kit enables our clinical customers to detect multiple genetic rearrangements from each tumor sample,” said Mike Nolan, vice president and general manager of Oncology at Thermo Fisher Scientific. “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 new CE-IVD kits are robust and can be easily implemented into clinical laboratories,” said Jose Costa, from the IPATIMUP Medical Faculty of Porto, Portugal. “The comprehensive content, selected to align with patient prognosis and therapy decision guidance, represents the new generation of genetic tests for colon and lung cancer patients."

"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,” added Nolan. “We will continue expanding our oncology product portfolio to meet the needs of our clinical customers and help move precision medicine forward.”