Press Release

Guardant Health Initiates ECLIPSE Pivotal Study for its LUNAR-2 Blood Test for Colorectal Cancer Screening

October 23, 2019 at 4:03 PM EDT
Prospective Study Expected to Enroll 10,000 Average-Risk Patients to Assess Performance of Blood Test for Early Detection of Colorectal Cancer
AmirAli Talasaz
  President & COO
 
Helmy Eltoukhy
  Chief Executive Officer

REDWOOD CITY, Calif., Oct. 23, 2019 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) has initiated the ECLIPSE trial, a 10,000-patient registrational study to evaluate the performance of its LUNAR-2 blood test to detect colorectal cancer (CRC) in average-risk adults. The test is intended to improve CRC screening rates by offering a simpler blood test that overcomes barriers associated with current testing methods.

The U.S. Preventive Services Task Force recommends screening average-risk adults for colorectal cancer starting at age 50 and then regularly thereafter.1 Current screening methods are time consuming and additionally in the case of colonoscopy, invasive. Despite the availability of testing options, one-third of adults in the U.S. are not up-to date even though regular screening for colorectal cancer has been shown to improve survival.2,3

“Colorectal cancer screening is known to be effective in saving lives. Unfortunately, one-third of adults do not adhere to national screening recommendations. Because blood tests are a routine part of a patient’s office visit, we believe our blood test could be easily integrated into an already established workflow which will lead to significantly increased screening rates,” said Guardant Health President AmirAli Talasaz, PhD. “We are excited about the performance of the LUNAR-2 assay and look forward to the results of this large prospective study to drive both payer coverage and clinical adoption.”

The ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter) trial is a prospective, multi-site registrational study. It is expected to enroll approximately 10,000 individuals aged 45-84 who are at average risk for colorectal cancer. The primary objective is to evaluate the performance of the company’s LUNAR-2 blood test to detect colorectal cancer in a screen-relevant population. If successful, Guardant expects data from the trial will support a premarket approval (PMA) submission to the FDA. Recent data showed that Guardant’s multi-dimensional approach to analyzing somatic genomic, epigenomic, and fragmentomic signals from circulating tumor DNA in the blood was effective in detecting colorectal cancer in the early stages.4

“The LUNAR-2 assay has shown high sensitivity in detecting colorectal cancer and we are ready to make this our first indication for the early detection of cancer in asymptomatic individuals. We believe it is an ideal disease to address first, because the low compliance of current approaches creates a clear unmet medical need, the tumor biology is well captured by our blood-based technology, and existing pathways are in place for both downstream intervention and reimbursement, making it easier to drive clinical use,” said Guardant Health CEO Helmy Eltoukhy, PhD. “Initiating this study marks a major step forward in our mission of conquering cancer with data.”

More details about ECLIPSE can be found at NCT04136002.

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 bio-pharmaceutical companies and all 28 of the National Comprehensive Cancer Network centers.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the ECLIPSE trial, 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. US Preventive Services Task Force. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23):2564–2575. doi:10.1001/jama.2016.5989
  2. Joseph DA, King JB, Richards TB, et al. Use of Colorectal Cancer Screening Tests by State. Prev Chronic Dis 2018;15:170535. DOI:http://dx.doi.org/10.5888/pcd15.170535external
  3. Brenner H, Jansen L, Ulrich A, et al. Survival of patients with symptom- and screening-detected colorectal cancer. Oncotarget. 2016;7(28):44695–44704. doi:10.18632/oncotarget.9412
  4. Kim ST, Raymond VM, Park JO, et al. Combined genomic and epigenomic assessment of cell-free circulating tumour DNA (ctDNA) improves assay sensitivity in early stage colorectal cancer (CRC). Proceedings: AACR Annual Meeting 2019; March 29-April 3, 2019; Atlanta, GA, DOI: 10.1158/1538-7445.AM2019-916

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/95d59b83-860c-4ba8-8740-4a76c6d908e2
https://www.globenewswire.com/NewsRoom/AttachmentNg/cc5e6871-7e9b-4687-b5af-0c41be5c3752

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Source: Guardant Health, Inc.