Press Release

Guardant Health Announces Launch of the LUNAR Assay for Detection of Early-Stage Cancer and Recurrence to Academic and Biopharmaceutical Researchers

January 7, 2019 at 7:00 AM EST

REDWOOD CITY, Calif., Jan. 07, 2019 (GLOBE NEWSWIRE) -- The LUNAR assay, a new blood-based assay intended to detect early-stage cancer and recurrence of disease, is now available from Guardant Health, Inc. (Nasdaq:GH), for research use by biopharmaceutical and academic researchers.

The assay, was developed under the company’s LUNAR program for early-stage detection and recurrence monitoring. It is based on biological insights from more than 80,000 cancer patients tested with Guardant360, the industry leading comprehensive liquid biopsy test, as well as learnings from whole-genome sequencing liquid biopsy data.

“Earlier intervention using precision medicine in oncology could potentially improve outcomes for substantial numbers of cancer patients. We believe this cutting-edge assay may be the catalyst to meaningfully increase survivorship, cures, and ultimately public health,” said Leena Das-Young, Pharm.D., General Manager of Guardant’s early-stage cancer program and Chief LUNAR Officer. “We’re very encouraged by the emerging LUNAR clinical data, and look forward to the results from prospective clinical and real-world trials as the program progresses.”

The LUNAR assay has been designed to overcome a variety of challenges that have confounded prior approaches for the detection of early-stage cancers, including inadequate tissue, biological noise, and the limited sensitivity of genomic-only tests. With a single blood draw, the assay is simultaneously able to detect both genomic alterations and epigenomic signatures with high clinical sensitivity and specificity. The assay improves upon Guardant360’s market-leading performance by accurately reporting genomic alterations down to allele frequencies of 0.01%, and effectively filtering out biological noise sources, such as, mutations caused by clonal hematopoiesis of indeterminate potential. The incorporation of biologically relevant epigenomic signatures is critical in increasing the sensitivity of the assay to early-stage cancers.

Multiple top-tier academic research networks and biopharma companies will utilize the LUNAR assay in studies involving adjuvant therapy decision-making, recurrence monitoring, and screening for early-stage cancer. The clinical version of the test for IUO use in prospective studies is expected to launch in the second half of 2019.

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.  Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.  In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, such as statements about the expected timing for a clinical launch of the LUNAR assay. Such statements reflect Guardant Health’s current expectations, forecasts and assumptions. Actual results may vary materially from forward-looking statements due to risks, uncertainties and other factors, known and unknown to Guardant Health as of the date hereof, such as those discussed in Guardant Health’s filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in its Quarterly Report for the period ended September 30, 2018 and in its subsequent filings 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 should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Guardant Health disclaims any obligation to update any forward-looking statements, except as required by law.

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

Media Contact:
Josh Wein or Ian Stone
press@guardanthealth.com

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Source: Guardant Health, Inc.