Tuesday, April 16, 2024

Guardant Health launches Shield blood-based screening test for colorectal cancer in South Korea

SINGAPORE, Nov. 13, 2023 /PRNewswire/ — Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced that it has launched its blood-based colorectal cancer screening test, ShieldTM, in collaboration with Samsung Medical Center in South Korea.

Colorectal cancer (CRC) is one of the most commonly diagnosed cancers and the third-leading cause of cancer-related deaths in South Korea.1,2 Guardant Health’s Shield test, which can be used for regular CRC screening in eligible individuals, is an innovative test that can detect cancer in its early stages by analysing circulating tumour DNA (ctDNA), which is produced when tumours shed small pieces of their genetic material into the bloodstream. In the pivotal ECLIPSE study, which enrolled over 20,000 patients, the Shield test achieved 83% sensitivity for the detection of colorectal cancer in average-risk adults in the U.S., with specificity of 90%.3

Early detection is essential to reduce colorectal cancer mortality. Colonoscopy and faecal tests are generally used for early detection, however, compliance rates for these screening tests are low and have remained stagnant since 2014.4 The primary reasons for lack of compliance with CRC screening recommendations include not having any symptoms of CRC, lack of time for a colonoscopy procedure, which requires a few days of preparation, and fear of an invasive colonoscopy procedure.4 Since the launch of the lab-developed version of the Shield test in May 2022, it has shown approximately 90% adherence in a real-world clinical setting, demonstrating the value of blood-based screening to increase adherence to recommended screening protocols.5

“Colorectal cancer rarely has symptoms in its early stages, and by the time symptoms appear, the disease has often progressed considerably. Therefore, early detection through a screening test is critical,” said Health Promotion Center of Samsung Medical Center. “The Shield blood test can broaden the range of choices for colorectal cancer screening. We are confident that by introducing a high-quality blood-based screening test, we can meet the needs of both patients and healthcare providers and help improve screening compliance.”

“We are pleased to be able to help address the high rates of colorectal cancer in South Korea by introducing the Shield test at Samsung Medical Center,” said Simranjit Singh, Chief Executive Officer of Guardant Health Asia, Middle East & Africa. “We are confident that this revolutionary screening test will help healthcare professionals detect colorectal cancer early, when it’s most treatable, with a simple blood draw.”

About the Shield Test
The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumours, called ctDNA. Specifically, the test identifies certain characteristics of the DNA that may indicate the presence of cancer. The clinical performance of the Shield assay in detecting colorectal cancer in average-risk individuals was validated in ECLIPSE, a registrational study that enrolled over 20,000 patients in the U.S. The test demonstrated 83% sensitivity for the detection of colorectal cancer with specificity of 90%. The test also demonstrated 13% sensitivity in detecting advanced adenomas.

Shield is commercially available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer. Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation. More information about the Shield test is available at bloodbasedscreening.com. For more information about the ECLIPSE study (NCT04136002), visit www.clinicaltrials.gov.

About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360® CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantINFINITY® tests for advanced stage cancer, and Guardant Reveal™ for early-stage cancer. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com or guardanthealthamea.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the 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 captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2022, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. 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.

References

  1. National Cancer Information Center (NCIC). Cancer in statistics available at https://www.cancer.go.kr/ accessed on 12 October 2023.
  2. Statistics Korea (2023). 2022 Cause-of-death statistics available at https://www.kostat.go.kr/board.es?mid=a10301060200&bid=218&act=view&list_no=427216 accessed on 12 October 2023.
  3. Chung, et al. Digestive Diseases Week 2023. Abstract #913e available at  https://guardanthealth.com/wp-content/uploads/ChungGrady_DDW_Abstract-913e_FINAL.pdf accessed on 12 October 2023
  4. Park B, Lee YY, Song SY, Shin HY, Suh M, Choi KS, Jun JK.  Trends of Colorectal Cancer Screening Rates in Korea: Korean National Cancer Screening Survey 2005–2020.  Gut and Liver 2022; 16:930-941.  https://doi.org/10.5009/gnl210419
  5. Shield LDT internal data on file. Guardant Health, Inc.
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