Data at AACR Demonstrate Growing Clinical Utility of Guardant Health Liquid Biopsies in the Treatment and Management of Advanced Cancers
04/10/2021 - 08:35 AM
Guardant Health, Inc. (Nasdaq: GH), along with leading academic institutions and pharmaceutical companies, presents new data at the AACR Virtual Annual Meeting I, April 10-15, 2021, highlighting the use of the company’s proprietary blood tests to advance precision oncology.
Key findings demonstrate the value of Guardant360® , Guardant360 CDx, and GuardantOMNI™ liquid biopsy tests to detect clinically actionable mutations, inform treatment for patients as their cancer progresses, and reveal tumor evolution and resistance in response to interventional therapies, including immunotherapies.
“At this year’s AACR, we highlight the growing clinical utility of our liquid biopsy tests, from revealing critical genomic and molecular insights that contribute to vitally important drug development efforts, to further informing treatment decisions as patients with advanced disease progress,” said Helmy Eltoukhy, Guardant Health CEO. “As we exit the pandemic, the ability to effectively treat advanced cancers that may have remained undetected during the past year will be critical, and there is no room for error or further delays in finding the right treatment or clinical trial. Now more than ever, our liquid biopsies are needed to accelerate the accessibility of effective treatment options for patients most in need of precise clinical therapies.”
Guardant360 CDx validated for use with Amgen’s investigational KRASG12C inhibitor, sotorasib
Data from the phase 2 CodeBreaK 100 trial evaluating investigational sotorasib in patients with advanced non-small cell lung cancer (NSCLC) showed the objective response rate was comparable in patients selected using Guardant360 CDx liquid biopsy or tissue biopsy, with high concordance demonstrated between the two assays.
“The study results highlight that the Guardant360 blood-based companion diagnostic test was effective at selecting patients with KRAS G12C who may benefit from treatment with sotorasib, said Darryl Sleep, senior vice president, global medical and chief medical officer, Amgen. “KRAS G12C can only be detected with a biomarker test and with one in eight patients with NSCLC harboring the KRAS G12C mutation, there is a critical need to improve access to high quality diagnostics and more routine screening.”
Guardant360 CDx delivers results at low inputs, which can potentially increase patient samples for clinical decision-making and clinical studies
Study shows Guardant360 CDx provides comprehensive tumor profiling results with robust analytical performance at demonstrated low inputs (5ng cutoff). These data suggest that Guardant360 CDx has the potential to guide therapy decisions for about 34% more patients compared to some liquid biopsies that use 2 blood collection tubes (BCT) for minimal 30ng of cell-free DNA (cfDNA). The data also show that the ability to process samples below 15ng input from a single BCT increases the yield of EGFR driver mutations by >25% . Furthermore, because retrospective studies are often performed with as little as 2mL of plasma, the study shows that the Guardant360 CDx is expected to return valid results on over 88% of such samples, which may be outside the performance specifications for other assays.
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About GH
we believe conquering cancer is a big data problem. that’s why we built the world’s leading comprehensive liquid biopsy. this non-invasive tool for accessing and sequencing tumor dna is used by thousands of oncologists to help tens of thousands of advanced cancer patients. we believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. we’re working on some exciting ones, including in early detection, where the impact on patients can be profound. we’ve raised more than $500 million from investors including sequoia capital, khosla ventures, orbimed, and softbank.
