Natera has launched Signatera, a research-use-only circulating tumor DNA assay. Signatera consists of analyzing whole-exome sequencing data from a patient's tumor sample to design a targeted, custom-designed assay to analyze 16 or more mutations that were identified in the tumor sample. According to Natera, the assay can detect variant allele frequencies down to 0.01 percent and is optimized to achieve high specificity by requiring detection of multiple mutations for a ctDNA-positive call, leading to fewer false positives.
Sunquest Mitogen LIMS and Genetic Analysis Software
Sunquest Information Systems has released Sunquest Mitogen, a new laboratory information management system and genetic analysis software platform to support molecular diagnostics and precision medicine. Mitogen, based in part on technology Sunquest acquired when it bought GeneInsight and UniConnect in 2016, is meant to help both wet and dry labs move into next-generation sequencing.
Cynvenio Biosystems ClearID HER2 Expression Test
Cynvenio Biosystems launched its ClearID HER2 Expression Test. The liquid biopsy test allows doctors to perform real-time monitoring and analysis of HER2 levels in patients with a normal blood draw. It leverages Cynvenio's liquid biopsy technology and uses antibodies against EpCAM, TROP2, HER2, and EGFR. The test has a turnaround time of three to seven days and is processed by Cynvenio's CLIA/CAP laboratory in California.
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