REDWOOD CITY, Calif., Dec. 13, 2019 (GLOBE NEWSWIRE) -- In 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 treatment.1 The use of a blood test provided comprehensive genotyping for late stage breast cancer patients, many with bone metastases that are often difficult to biopsy and typically yield insufficient material for biomarker analysis.2

The study, plasmaMATCH, sponsored by the Institute of Cancer Research London, demonstrated that Guardant360 had 96%-99% overall concordance with digital droplet PCR (ddPCR) liquid biopsy, an orthogonal method. Guardant360 also detected significantly more targetable alterations than hotspot testing, including over 35 percent more PIK3CA mutations1 that can now be effectively targeted by recently FDA approved therapies.3 Guardant360 also detected significantly more ESR1 mutations and found previously undetected microsatellite instability (MSI) and ERBB2 amplifications and mutations, all of which are clinically actionable mutations. The findings were presented at the 2019 San Antonio Breast Cancer Symposium.

“The plasmaMATCH study results, mark an important step towards establishing liquid biopsies, such as Guardant360, 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,” said Professor Nicholas Turner, PhD, lead investigator, Professor of Molecular Oncology at the Institute of Cancer Research, London, and Consultant Medical Oncology at The Royal Marsden. “We have now confirmed that liquid biopsies can quickly give us a bigger picture of what mutations are present within multiple tumours throughout the body, while also getting the results back to patients accurately and faster than we ever could before.”

“As the number of treatment-relevant genomic alterations in metastatic breast cancer continues to grow, it is critical that oncologists have a simple and reliable way to comprehensively test for this information about their patients,” said Guardant Health Global Chief Medical Officer Rick Lanman, MD. “Guardant360 detected 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, somatic BRCA1/2 mutations, NTRK fusions and microsatellite instability which are not identified with routine hotspot testing. Guardant is well-positioned to guide what represents the dawn of a new era in personalized oncology for all patients with metastatic breast cancer.”

The vast amount of data presented at the 2019 San Antonio Breast Cancer Symposium using Guardant360 for comprehensive genomic profiling highlights the increasingly important value of blood-based testing for patients with metastatic breast cancer 4-6 where the prevalence of clinically actionable targets and the emergence of targeted treatments, immunotherapies and tumor-agnostic inhibitors continues to grow.

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 for 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.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the adoption of Guardant Health’s products, which involve risks and uncertainties that could cause Guardant Health’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2018, and in its other reports filed by Guardant Health with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.

Investor Contact:
Lynn Lewis or Carrie Mendivil
investors@guardanthealth.com

Media Contact:
Anna Czene or Ian Stone
press@guardanthealth.com

References

  1. Kingston B, Bye H, Hubank M, et al. The genomic landscape of breast cancer based on ctDNA analysis: data from the plasmaMATCH trial. Presented at: 2019 San Antonio Breast Cancer Symposium; December 10-14; San Antonio, TX. Abstract GS3-07
  2. Ibrahim MF, Hilton J, Addison C, et al. Strategies for obtaining bone biopsy specimens from breast cancer patients - Past experience and future directions. J Bone Oncol. July 2016
  3. US FDA News Release: FDA approves first PI3K inhibitor for breast cancer. May 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-pi3k-inhibitor-breast-cancer
  4. Kiedrowski LA, Juric D, Hardin AI, et al. PIK3CA mutational analysis using cell-free DNA next-generation sequencing detects activating mutations that may be missed with targeted hotspot testing. Presented at: 2019 San Antonio Breast Cancer Symposium; December 10-14; San Antonio, TX. Abstract P4-10-15
  5. Davis AA, Jacob S, Gerratana L, et al. Landscape of circulating tumor DNA (ctDNA) in metastatic breast cancer. Presented at: 2019 San Antonio Breast Cancer Symposium; December 10-14; San Antonio, TX. Abstract P5-01-08
  6. Chen C, Sahu A, Price K, et al. Plasma sequencing demonstrates that breast cancer patients have a higher prevalence of clonal and multiple PIK3CA mutations than other solid tumor patients. Presented at: 2019 San Antonio Breast Cancer Symposium; December 10-14; San Antonio, TX. Abstract P4-10-34

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