Guardiant360 – pro
Guardiant is one of several panels of tumor markers designed to give the oncologist an option of treating in a personalized manner directed to the specific markers that the cancer expresses. It is a clinical diagnostic test based on sequencing 72 genes and Guardiant claims to be highly accurate in identifying genomic alterations.
NCCN does recommend “broader molecular profiling” for non-small lung cancer, albeit without specifically naming the Guardiant test. However, it does not name any other test either. For this reason, I consider the TISSUE Guardiatn360 test as meant or included by NCCN, since it is one of the more established tests of this kind. However, cDNA test is different and it is specifically mentioned in NCCN as not being included in the NCCN recommendations.
“The growing use of next generation-sequencing to identify cancer-associated alterations as well as the increasing number of targeted drugs holds promise for better matching patients with cancer with effective therapies. The FoundationOne (F1; Foundation Medicine) test sequences clinical tumor samples to characterize the exons of 315 cancer-associated genes and introns from 28 genes involved in rearrangements. The Guardant360 (G360; Guardant Health) test uses cell-free circulating DNA from blood to sequence 70 genes. Both the F1 and G360 tests have high specificities (>99%) and somewhat lower sensitivities. However, little is known about how different next-generation sequencing tests compare when used in the same patients with cancer. We compared reports from F1 and G360 testing in 9 patients from a community oncology practice to determine the level of concordance between the platforms.” (Kuderer, N. M. et al .2017)
“Next-generation sequencing of cell-free circulating solid tumor DNA addresses two challenges in contemporary cancer care. First this method of massively parallel and deep sequencing enables assessment of a comprehensive panel of genomic targets from a single sample, and second, it obviates the need for repeat invasive tissue biopsies. Digital Sequencing is a novel method for high-quality sequencing of circulating tumor DNA simultaneously across a comprehensive panel of over 50 cancer-related genes with a simple blood test. Here we report the analytic and clinical validation of the gene panel. Analytic sensitivity down to 0.1% mutant allele fraction is demonstrated via serial dilution studies of known samples.” (Lanman, R. B. et al. 2015)
“The Guardant360 (G360) de-identified database of NSCLC cases was queried to identify 88 consecutive patients with 96 plasma-detected ALK fusions. G360 is a clinical cfDNA next-generation sequencing (NGS) test that detects point mutations, select copy number gains, fusions, insertions, and deletions in plasma.” (McCoach, C. E. et al. 2018)
PEER REVIEWED PUBLICATION/LITERATURE:
Bonifacio M et al, Safety and efficacy of switching from branded to generic imatinib in chronic phase chronic myeloid leukemia patients treated in Italy.Leuk Res. 2018 Nov;74:75-79.
Kuderer, N. M., Burton, K. A., Blau, S., Rose, A. L., Parker, S., Lyman, G. H., & Blau, C. A. (2017). Comparison of 2 Commercially Available Next-Generation Sequencing Platforms in Oncology. JAMA oncology, 3(7), 996998. doi:10.1001/jamaoncol.2016.4983
Lanman, R. B., Mortimer, S. A., Zill, O. A., Sebisanovic, D., Lopez, R., Blau, S., Talasaz, A. (2015). Analytical and Clinical Validation of a Digital Sequencing Panel for Quantitative, Highly Accurate Evaluation of Cell-Free Circulating Tumor DNA. PloS one, 10(10), e0140712. doi:10.1371/journal.pone.0140712
McCoach, C. E., Blakely, C. M., Banks, K. C., Levy, B., Chue, B. M., Raymond, V. M., Doebele, R. C. (2018). Clinical Utility of Cell-Free DNA for the Detection of ALK Fusions and Genomic Mechanisms of ALK Inhibitor Resistance in Non-Small Cell Lung Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research, 24(12), 27582770.