Biocartis Idylla POLE-POLD1 Mutation Assay

Biocartis has launched its Idylla POLE-POLD1 Mutation Assay for research use only. This real-time PCR assay for the fully automated Idylla platform is designed to detect the hypermutated phenotype associated with mutations in POLE and POLD1, which encode proteins that ensure proper DNA amplification. Such mutations have been identified in endometrial and other cancers. The new assay detects 17 point mutations in the POLE gene and one mutation in the POLD1 gene, therefore covering 99 percent of the known POLE and POLD1 pathogenic mutations in a single cartridge. The test is optimized for use with formalin-fixed, paraffin-embedded tissue specimens. It has a hands-on time of under three minutes and a turnaround time of approximately 95 minutes, Biocartis said.