Guardant Health’s Guardant Reveal molecular residual disease (MRD) test detected more than 80 percent of melanoma recurrences in prospective study of 48 patients, according to a new study. Often, the test identified recurrence months before it was detected by other methods.
Researchers behind the COSMOS-MEL01 study analyzed 280 longitudinal surveillance samples from 48 patients with clinical stage II-III melanoma treated with surgery. During surveillance, Guardant Reveal detected 81 percent of distant recurrences and showed 100 percent specificity in samples from patients who remained recurrence-free. Circulating tumor DNA (ctDNA) detection preceded clinical identification of recurrence by a median of 70.5 days, and by up to 273 days in some patients.
The researchers published the results of the study Oct. 5 in Cancer Research Communications.
“Our findings suggest that serial ctDNA testing may provide a dynamic view of recurrence risk and potentially complement routine imaging, particularly in identifying patients at increased risk of distant relapse,” Kenjiro Namikawa, chief of the Department of Dermatologic Oncology at National Cancer Center Hospital in Tokyo and first author of the study, said in a statement. “Further studies will be important to determine whether and how ctDNA results could be incorporated into postoperative treatment and surveillance decisions.”
In a statement, Guardant said MRD detection about four weeks after surgery was independently associated with an approximately 12-fold increased risk of recurrence and a more than 30-fold increased risk of death compared to patients who tested MRD-negative at the same timepoint.
COSMOS-MEL01 was a prospective, multicenter evaluation of MRD testing in resected stage II-III melanoma. COSMOS (COnquer Solid Malignancies by blOod Screening) is a Guardant program evaluating MRD detection with Reveal across six cancer types.
Guardant Reveal is currently marketed for MRD detection in early-stage colorectal, breast and lung cancers.
“COSMOS-MEL01 extends the growing body of evidence supporting Guardant Reveal into melanoma and demonstrates the power of epigenomic MRD detection across a diverse set of melanoma subtypes,” Guardant Co-CEO and Cofounder Helmy Eltoukhy said in a statement. “The ability to identify patients at very high risk shortly after surgery, and to detect molecular recurrence before it appears clinically, could help inform more personalized surveillance and clinical trial strategies.”