The test, which has been launched in partnership with Samsung Medical Center, is intended for regular screening of CRC in eligible people.
It identifies early-stage cancer by examining circulating tumour DNA (ctDNA), generated when tumours release small pieces of their genetic material into the bloodstream.
Particularly, the test detects certain DNA characteristics, which may indicate the presence of cancer.
The Shield assay’s ability to detect CRC in average-risk individuals was validated in the ECLIPSE registrational study, which enrolled more than 20,000 subjects in the US.
The test showed a sensitivity of 83% in identifying CRC, with a 90% specificity. It also showed 3% sensitivity in identifying advanced adenomas.
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Guardant Health Asia, Middle East and Africa CEO Simranjit Singh said: “We are pleased to be able to help address the high rates of CRC in South Korea by introducing the Shield test at Samsung Medical Center.
“We are confident that this revolutionary screening test will help healthcare professionals detect CRC early, when it’s most treatable, with a simple blood draw.”
In May 2023, Guardant Health obtained approval from Singapore’s Health Sciences Authority for the liquid biopsy test, Guardant360 CDx, for patients with advanced solid cancers.
The minimally invasive test is suitable for performing tumour mutation profiling, which is also known as comprehensive genomic profiling.