Guardant Health Announces Launch of the LUNAR Assay for Detection of Early-Stage Cancer and Recurrence to Academic and Biopharmaceutical 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
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.
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
Lynn Lewis or Carrie Mendivil
Josh Wein or Ian Stone
Source: Guardant Health, Inc.