28 Jun Guardant Health’s LUNAR-2 Assay: A Big Step Toward Liquid Biopsy Diagnosis of Colon Cancer
MedicalResearch.com Interview with:
Dr. Kathryn Lang
VP, Outcomes and Evidence
MedicalResearch.com: What is the background for this study?
Response: Despite a wide variety of screening methods available and increasing public awareness of the value of early detection, colorectal cancer (CRC) remains a leading cause of cancer-related deaths. However nearly 1 in 3 adults in the United States is not compliant with screening recommendations, with most citing that current screening methods are time consuming, unpleasant (stool-based testing), and in the case of colonoscopy, invasive. A blood-based CRC screening test could improve compliance rates by providing physicians with an opportunistic, in-office screening modality. However, demonstrating the clinical utility of blood-based cell-free circulating tumor DNA (ctDNA) fractions for the detection of cancer in asymptomatic individuals has thus far been challenged by the failure to achieve clinically meaningful sensitivity and specificity thresholds due to significantly lower tumor cell-free free DNA fractions and the increasing relevance of biological confounders.
The multi-modal approach of Guardant Health’s LUNAR-2 assay (genomics, methylation and fragmentomics) coupled with advanced bioinformatic analysis and a focused approach of honing in on the unique signals of CRC has been shown in previously reported cohorts to perform with sensitivity and specificity which satisfies the needs of clinicians in screening for CRC.
MedicalResearch.com: What are the main findings?
Response: Guardant Health’s blood-based integrated genomic and epigenomic multi-modal ctDNA test achieved clinically significant values for the detection of colorectal cancer with 90% sensitivity and 94% specificity. The specificity of the test improved further (99%) when tested on samples from colonoscopy screened negative patients without any reduction in sensitivity. The results demonstrate this multi-modal ctDNA assay (LUNAR-2) consistently provides sufficient sensitivity and specificity for clinical detection of early-stage CRC. A prospective, large scale, average-risk CRC screening study is underway in a population-level observational research study (ECLIPSE, NCT04136002).
MedicalResearch.com: What should readers take away from your report?
Response: Guardant Health is making progress towards clinically validating its early cancer screening test, and developing the evidence necessary for FDA approval and coverage for payers, and for its eventual routine use in detecting early-stage colorectal cancer. Such a test, currently being evaluated in one of the largest clinical studies in the world, would mean that more people have access to a screening modality that can be readily administered during visits to a primary care provider’s office.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Blood-based screening tests using ctDNA could bring significant value to the landscape of early detection in colorectal cancer
More research is needed for underserved populations to better understand barriers to early cancer detection screening where a blood-based test could help. Further, the increase in cases of CRC in those under the age of 50 is an important consideration (ECLIPSE is recruiting subjects between 45 and 84 years).
MedicalResearch.com: Is there anything else you would like to add?
Response: While test performance is of critical importance, compliance with screening is a key component of ensuring early detection of CRC: the test which is not done has a sensitivity of zero percent after all. The availability of a blood-based test that is simple to administer in a doctor’s office as part of routine visits has the potential to revolutionize early detection of CRC and have measurable benefits to public health.
Integrated genomic and epigenomic cell-free DNA (cfDNA) analysis for the detection of early-stage colorectal cancer
Oscar Westesson PhD1, Haley Axelrod PhD1, Jason Dean PhD1, Yupeng He PhD1, Paul Sample PhD1, Elena Zotenko PhD1, Ruth B. McCole PhD1, Mohit Goel MS1, Charbel Eid PhD1, Jessica Kurata PhD1, Yu Kong PhD1, Anna Hartwig PhD1, Matthew Snyder PhD1, Will Greenleaf PhD1, Victoria M. Raymond MS1, Darya Chudova PhD1, Ariel Jaimovich PhD1, AmirAli Talasaz PhD1 . 1. Guardant Health, Inc, Redwood City, CA, USA
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