DIACARTA Inc., a precision molecular diagnostics company headquartered in Richmond, California, today announced that it is launching a new suite of CE-IVD marked highly sensitive hydrolysis probe (TaqMan qPCR) based QClamp® assays for detection of common cancer mutations in genes, such as KRAS, NRAS, BRAF, EGFR, PIK3CA and JAK2, using tissue biopsy (FFPE) and liquid biopsy (cfDNA) samples. The tests are validated on standard real-time qPCR instruments including Thermo Fisher Scientific Quantstudio 5, Roche LightCycler® 480 and Bio-Rad CFX384. The analytical sensitivity ranges from 0.1 to 0.5% for variant allelic frequency, providing lower detection limit compared with competition due to application of DiaCarta’s proprietary XNA technology. The XNA technology selectively enriches mutant sequences while suppressing amplification of wild-type sequences, allowing identification of cancer gene mutations from small population of cells among large number of normal cells, thus making early cancer gene mutation detection possible.
High sensitivity detection of somatic cell gene mutations is not only critical for testing due to tumor tissue heterogeneity but also important for guidance in targeted therapy and monitoring of disease recurrence. DiaCarta’s highly innovative QClamp® TaqMan gene mutation tests are configured to work with DNA extracted from traditional formalin fixed paraffin embedded (FFPE) tumor biopsy samples as well as minimally invasive liquid biopsy plasma samples.