Guardant Health is a late-stage startup in Redwood City focusing on analysis of circulating tumor DNA (ctDNA) in blood, using optimized laboratory assays, vast data sets, and advanced analytics. The Guardant360 assay covers 73 cancer genes and is now the most widely ordered comprehensive liquid biopsy test used to assess treatment options for patients with advanced stage solid tumors. It utilizes a proprietary digital sequencing approach with molecular barcoding for error correction, resulting in highly sensitive and specific detection of mutations down to one or two molecules. An in-house bioinformatics pipeline was developed to detect and report somatic point mutations, short insertions/deletions, copy number amplifications and gene rearrangements.
To date, Guardant360 has been run on over 35,000 patient samples, enabling ongoing research and development using machine learning and other mining techniques to enhance detection capabilities and understand cancer genomics. An initial study of 15,000 samples revealed that the landscape of somatic mutations in ctDNA is concordant with that of large tissue sequencing studies such as TCGA. However, ctDNA data is representative of later stage cancer than TCGA and, as such, reveals insights into drug resistance and mutational heterogeneity.
Additional assays are currently being developed at Guardant Health, including Project LUNAR – an effort to apply the technology to early cancer detection and recurrence monitoring, as well as GuardantOMNITM – a 500-gene panel developed in partnership with large pharma for immuno-oncology applications. These assays will broaden the gene content and tumor representation in Guardant’s database and allow for further large-scale analyses.
Using these data, Guardant is actively researching ctDNA fragmentation patterns, which exhibit a non-random distribution of length and placement due to the nature of cleavage around nucleosomes. Additional signal can be gained from mining these fragmentation patterns across tumor types in the largest available cohort of cancer patients to uncover chromatin dynamics and enhance detection sensitivity.
Guardant Health is tackling some of the most impactful problems across cancer care and genomics using advanced technology and analytics. By continuing to leverage the data collected, Guardant aims to innovate methodologies and discoveries in this field.