CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
February 2019—The Lunar assay, a new blood-based assay intended to detect early-stage cancer and recurrence of disease, is available from Guardant Health for research use by biopharmaceutical and academic researchers.
The assay was developed under the company’s Lunar program and is based on biological insights from more than 80,000 cancer patients tested with the Guardant360 liquid biopsy test, as well as learnings from whole-genome sequencing liquid biopsy data. It is able to detect with a single blood draw genomic alterations and epigenomic signatures with high clinical sensitivity and specificity. The assay reports genomic alterations down to allele frequencies of 0.01 percent and filters out biological noise sources, such as mutations caused by clonal hematopoiesis of indeterminate potential.