Precision oncology company Guardant Health in collaboration with Samsung Medical Center has unveiled Shield blood-based screening test for colorectal cancer (CRC) in South Korea.
The Shield test is designed for the detection of colorectal cancer signals in the bloodstream from DNA that is shed by tumours, known as circulating tumor DNA (ctDNA).
This LDT (Laboratory Developed Test) is intended for regular CRC screening in eligible individuals.
In particular, the test finds specific DNA traits that can point to the existence of cancer, Guardant Health said.
The US-based precision oncology company applied to the US Food and Drug Administration (FDA) in March this year, seeking premarket approval (PMA) for the test.
Guardant Health Asia, Middle East & Africa chief executive officer Simranjit Singh said: “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.
“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.”
The Shield assay’s clinical performance in identifying colorectal cancer in people at average risk was confirmed in the registrational ECLIPSE study, which included more than 20,000 patients in the US.
According to the precision oncology company, the test showed a 90% specificity and 83% sensitivity in detecting colorectal cancer, Additionally, the test’s sensitivity for identifying advanced adenomas was found at 13%.
The lab-developed Shield test has been available since May 2022, and since then, it has demonstrated almost 90% adherence in a real-world clinical setting.
It has proved the usefulness of blood-based screening in raising adherence to advised screening procedures.
Currently, it is available commercially for eligible individuals by prescription only through healthcare professionals.
Samsung Medical Center Health Promotion Center said: “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.
“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.”
