On October 5, 2020 Guardant Health, Inc. (Nasdaq: GH). Despite advances in precision oncology, reported that progress is slowed by the limitations of tissue genotyping, which is traditionally used to enroll patients in clinical trials (Press release, Guardant Health, OCT 5, 2020, View Source [SID1234568116]). A new study published in Nature Medicine,1 led by the National Cancer Center Hospital East (NCCHE) in Japan, demonstrates that the Guardant360 liquid biopsy is not only concordant to tissue genotyping, but also accelerates clinical trial enrollment, detects more actionable alterations, and achieves similar treatment response rates and progression-free survival in patients with advanced gastrointestinal cancer. Publication link here.

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The study, SCRUM-Japan GOZILA, compares comprehensive genomic profiling using the Guardant360 liquid biopsy, versus tissue genotyping for trial enrollment into the SCRUM-Japan study network. Patients with advanced gastrointestinal cancer, including gastric and colorectal cancer, were matched to novel therapies that target the specific biomarkers identified. Compared to tissue genotyping (n=5,621) used in GI-SCREEN, the Guardant360 liquid biopsy (n=1,687) shortened screening duration by 67 percent (median 11 vs. 33 days) and improved trial enrollment rate by 132 percent (9.5 vs. 4.1 percent).

Additionally, the Guardant360 liquid biopsy revealed more actionable alterations because of its high success rate and ability to detect heterogeneously-distributed mutations which are often missed by single-locus tissue analysis. Most importantly, similar objective response rates and progression-free survival were seen in both studies, which included patients who were matched to interventional biomarker-targeted therapies when their cancer had progressed, after receiving first-line treatment.

"The data demonstrate that genomic profiling by ctDNA (circulating tumor DNA) analysis using the Guardant360 liquid biopsy has the advantage of shorter turnaround times and improved patient enrollment compared to tissue biopsy for clinical trials, without compromising treatment efficacy. The paradigm of precision oncology should be shifted toward greater use of liquid biopsies." said the Principal Investigator of this study Dr. Yoshiaki Nakamura, Attending Physician, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East.

AmirAli Talasaz, Ph.D., Guardant Health President added, "These data complement other studies supporting the routine use of the Guardant360 test in personalized treatment decisions for patients with advanced cancer, and its potential to significantly accelerate the development and delivery of innovation in precision medicine to patients."

The Guardant360 test is increasingly being used by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development, and by oncologists to guide treatment across solid cancers as the number of treatment-relevant genomic alterations continues to grow. Using next-generation sequencing, the Guardant360 test analyzes 74 genes using cell-free tumor DNA from blood samples and is broadly covered by Medicare for use across the vast majority of advanced solid tumors and many private payers. The Guardant360 CDx was recently approved by the FDA for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib).