Thermo Fisher Scientific on Monday announced the U.S. launch of its CE-IVD Oncomine Solid Tumor Fusion Transcript kit, which was devised to provide accurate and reliable multiplexed sequencing of formalin-fixed, paraffin-embedded tumor samples.
Designed as a next-generation sequencing diagnostic of fusion transcripts, the kit detects ALK, ROS-1, RET and NTRK1 genetic rearrangements in samples as small as 10 ng of RNA. The kit’s target focus is lung cancer samples, but it is capable of evaluating other solid tumors, the Waltham, Mass., company said.
Current attempts at detecting genetic rearrangements use multiple tests, each for an individual rearrangement, which risks consuming the tumor sample long before an actionable variant is uncovered. By contrast, the CE-IVD kit requires only a low RNA sample of FFPE tissue and can detect several rearrangements within a single sample.
In January, Thermo Fisher launched a similar kit in the EU, the CE-IVD Oncomine Solid Tumor DNA kit, which detects single nucleotide somatic changes, inversions, insertions and deletions, relying on as small a sample as 10 ng of FFPE DNA.
The company has no current plans to seek 510(k) FDA clearance for the CE-IVD Oncomine Solid Tumor Fusion Transcript kit, a spokesperson told Device Daily Wednesday. The product received CE mark approval in February. — Jason Scott