The firm will expand on its MSI assay for use in immunotherapy while developing liquid biopsy assays to monitor patients post therapy and for recurrence.
The firm plans to submit its Idylla MSI test for 510(k) clearance from the US Food and Drug Administration after receiving CE-IVD approval this morning.
The test uses multiplex PCR fragment analysis with Promega-designed five-mononucleotide repeat markers to detect the MSI-high phenotype within tumor tissues.
The firm's has expanded its ctDNA sequencing test to cover 17 genes, enough to provide a readout of microsatellite instability for guiding cancer immunotherapy use.
The firm's new RT-PCR assay identifies 20 gene fusion between NTRK1/2/3 and other genes, allowing clinicians to potentially detect rare forms of different cancers.
The partners will identify patients with gastrointestinal or endometrial cancers who may benefit from immune checkpoint inhibitor therapy using Biotype's technology.
Investigators showed that sequencing cell-free DNA could detect microsatellite instability, structural rearrangements, and clonal hematopoiesis in patients with metastatic disease.
