On October 25, 2021 Guardant Health, Inc. (Nasdaq: GH), reported that data at the American College of Gastroenterology Annual Scientific Meeting being held from October 22-27, showing its LUNAR-2 blood test, which has been developed to screen average-risk patients for colorectal cancer (CRC), offers optimized sensitivity and specificity in identifying those with early-stage CRC (Press release, Guardant Health, OCT 25, 2021, View Source [SID1234591912]). This study was selected by the ACG Abstract Selection Committee as the recipient of the International Award.

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In the study, researchers evaluated the LUNAR-2 test in a cohort of 699 patients with early-stage (Stage 1, 2, or 3) CRC and found the test achieved an overall sensitivity of 96% in detecting CRC and 94% specificity. These findings are on par with other currently available modalities, such as stool-based screening.1 The limitation of this retrospective study is that the biobanked samples are from individuals with known CRC and 37% of cases had asymptomatic disease.

"We know that the earlier CRC is detected, the better a person’s chances are of surviving it," said Dr. Hee Cheol Kim, study investigator and Professor of Surgery at Samsung Medical Center in Seoul, South Korea. "The clinically meaningful sensitivity and specificity of the LUNAR-2 blood test in detecting CRC, most notably in people with early-stage disease, indicates that it could be a very useful tool in improving patient outcomes."

A further analysis showed that in patients with Stage 1 and 2 CRC, whereby blood-based detection can be especially challenging, the test offered 93% overall sensitivity. Additionally, the blood-based test identified 90% of patients with asymptomatic Stage 1 or 2 CRC, suggesting the test may have meaningful performance in an average-risk screening population. These findings need to get further validated in a registrational screening trial.

"CRC screening saves lives, but we know that only about two-thirds of individuals get screened for CRC2 because current options, like a colonoscopy, are invasive and the preparation can be challenging, and other modalities, like stool based testing, have their own challenges to screening adherence," said AmirAli Talasaz, Guardant Health Co-CEO. "During the COVID-19 pandemic, screening rates have dropped, wellness visits have declined, and postponements of non-emergency medical procedures have made it harder for people to complete life-saving CRC screening. The study results show that the LUNAR-2 test could provide both patients and physicians with an easy-to-use and highly accurate CRC screening alternative in the form of a blood test."

The LUNAR-2 blood test aims to detect early-stage cancer in screen-eligible asymptomatic adults from a simple blood draw. The ECLIPSE trial (NCT04136002), a registrational study with more than 10,000-patients, is currently underway to evaluate the performance of the LUNAR-2 blood test to detect early-stage colorectal cancer. One of the largest cancer screening studies of its kind, ECLIPSE is expected to complete enrollment in 2021 and, if successful, data will support a pre-market approval (PMA) submission to the United States Food and Drug Administration (FDA).

Data Presented at ACG:

Title

Oral Abstract No.

Presenter

Multimodal circulating tumor DNA (ctDNA) blood-based colorectal cancer (CRC) screening test demonstrates clinically meaningful sensititive across multiple clinical perameters

24

Dr. Hee Cheol Kim