Guardant Health Publishes Extensive Validation of Guardant360® Assay Comprising Largest-Published Blood-Tissue Comparison

Study finds that Guardant360's positive predictive value approaches 100% for treatment-relevant alterations in lung cancer.

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Guardant Health

Apr 26, 2018, 01:00 ET

REDWOOD CITY, Calif., April 26, 2018 /PRNewswire/ -- The largest published comparison of comprehensive liquid biopsy results to tissue genotyping demonstrated high positive predictive value for the Guardant360 assay, Guardant Health announced. The results were published in Clinical Cancer Research in an extensive validation of Guardant360, the leading comprehensive liquid biopsy.

A retrospective analysis was conducted on a series of 6,948 consecutive lung cancer patients tested with Guardant360. Of those, 543 could be compared to tissue genotyping results performed by other providers. The results showed that for treatment-relevant alterations in EGFR, ALK, ROS1, RET, BRAF, MET, and KRAS, the positive concordance of Guardant360 to tissue genotyping was 92-100 percent. Furthermore, upon following up on cases that were Guardant360-positive for an ALK fusion but negative in tissue, all patients responded to treatment with a standard-of-care ALK inhibitor.

"These findings, comprising the largest published liquid-to-tissue concordance series, affirm the high accuracy of Guardant360-reported alterations," said Guardant Health Chief Medical Officer Richard Lanman, MD. "They demonstrate that doctors can confidently make treatment decisions based on Guardant360 results."

The study also included a blinded, blood-to-blood clinical validation study on a cohort of 222 patients that demonstrated nearly identical results for Guardant360 when compared to a well-validated liquid biopsy developed by Dana-Farber Cancer Institute. In a separate analysis of more than 10,500 clinical Guardant360 samples, the detection rate for circulating tumor DNA was 86% across all tumor types.

"We described definitive analytical and clinical validation studies of the Guardant360 assay and reported our experience applying this technology in the clinical care of more than 10,000 patients," said Guardant Health President AmirAli Talasaz, PhD. "These data support the use of Guardant360 as a clinically effective, accurate tumor genotyping alternative for patients, especially for whom tissue genotyping is infeasible."

The Guardant360 assay, the most widely used comprehensive liquid biopsy, was introduced in 2014. It has been ordered more than 50,000 times by more than 5,000 oncologists to look for somatic genomic alterations associated with targeted therapies in the tumor DNA of patients with advanced cancer. It is supported by more than 50 peer-reviewed journal publications that address its analytical validity, clinical validity, and clinical utility.

About Guardant Health
Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $500 million from leading investors. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially available and available in more than 30 countries. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc. Learn more at www.guardanthealth.com.

SOURCE Guardant Health