The Institute of Cancer Research London recently sponsored the plasmaMATCH study—showcasing the Guardant360’s ability to evidence 96-99% overall concordance with digital droplet PCR (ddPC) liquid biopsy, an orthogonal method.
The plasmaMATCH Study
The largest-ever liquid biopsy study for treatment selection in advanced breast cancer, investigators demonstrated in an 800-patient prospective clinical trial that the Guardant360® assay accurately detected biomarkers that can guide targeted cancer treatments. The use of a blood test offered comprehensive genotyping for late stage breast cancer patients, many with bone metastases that are often challenging to biopsy and frequently yield insufficient material for biomarker analysis.
The Guardant360 had 96-99% overall concordance with digital droplet PCR (ddPCR) liquid biopsy, an orthogonal method. The advanced assay also detected materially more targetable alterations than hotspot testing, including over 35% more PIK3CA mutations that can now be effectively targeted by recent FDA-approved therapies. Guardant360 also detected significantly more ESR1 mutations than found previously as well as undetected microsatellite instability (MSI) and ERBB2 amplifications and mutation, all of which are clinically actionable mutations. This was presented at the 2019 San Antonio Breast Cancer Symposium.
Clinical Investigator Comments
Professor Nicholas Turner, PhD, lead investigator, Professor of Molecular Oncology at the Institute of Cancer Research, London (Consultant Medical Oncology at the Royal Marsden), noted, “The plasmaMATCH study results, mark an important step towards establishing liquid biopsies, such as Guadant360, as the new standard of care to non-invasively detect patient subgroups with advanced breast cancer who will be sensitive to targeted therapies particularly if their cancer evolves to become drug resistant.” Turner went on to say that liquid biopsies are a real viable way to understand the bigger picture (when multiple tumors are present throughout the body) while ensuring faster more actionable assay results.
Why is this Relevant?
As Rick Lanman MD, Chief Medical Officer of Guardant360, mentioned, we face a situation with growing numbers of treatment-relevant genomic alterations in metastatic breast cancer. Hence, oncologists must have better, more reliable ways to perform comprehensive tests and determine best approachs for treatment. This is made possible because the “Guardant360 can detect changes in the genomic picture over time, such as a change in HER2 status over time, and also identifies targetable but uncommon genomic biomarkers such as uncommon PIK3CA mutations, some BRCA1/2 mutations, NTRK fusions and microsatellite instability which are not identified with routine hotspot testing,” noted Lanman.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes, and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients and LUNAR assay for research use and use in prospective clinical trials. In parallel, Guardant Health is actively exploring the performance of the LUNAR assay in initial studies related to screening and early detection in asymptomatic individuals.
The venture had two products, including 1) Guardant360, a liquid biopsy used to formulate treatment plans for advanced-stage cancer patients; and 2) GuardantOMNI, a liquid biopsy that biopharmaceutical companies are using to help develop drugs or therapies for cancer patients. The companies utilize OMNI to identify the most compatible patients to enroll in studies.
Founded in 2012, they went public and, presently, project $204 million in revenue with losses of $75 million and a market capitalization of $7.1 billion ($75.90 per share). Insiders control about 37%, according to Yahoo Finance. They hold about $523 million in cash. Although they are arguably well over-valued with such revenue and associated losses, the Motley Fool recently suggested they represent big potential with momentum, centering on big increases in year-over-year revenues, increases in full-year revenue forecast, growing numbers of clinical tests and industry sponsor tests—not to mention ongoing improvement in efficiencies. Moreover, they sell into a total addressable market of approximately $6 billion, a considerable upside given their current revenue being just a tiny fraction of market potential.
Professor Nicholas Turner, PhD, lead investigator, Professor of Molecular Oncology at the Institute of Cancer Research, London (Consultant Medical Oncology at the Royal Marsden)