Guardant Health study links liquid biopsy test to melanoma recurrence risk

Guardant Health (Nasdaq: GH) announced that Cancer Research Communications, a journal of the American Association for Cancer Research, has published results from the COSMOS-MEL01 study, evaluating the company's Guardant Reveal blood test for molecular residual disease (MRD) detection in patients with resected stage II–III melanoma.

The study analyzed 280 longitudinal surveillance samples from 48 patients treated with surgery. According to the published findings, detection of circulating tumor DNA (ctDNA) following surgery was associated with recurrence and melanoma-related death. The test detected 81% of distant recurrences, with 100% specificity in post-treatment samples from patients who remained recurrence-free. ctDNA detection preceded clinical identification of recurrence by a median of 70.5 days, with a lead time of up to 273 days.

The study also reported that MRD detection approximately four weeks after surgery was independently associated with an approximately 12-fold increased risk of recurrence and a greater than 30-fold increased risk of death.

"Patients with resected, high-risk melanoma need more precise tools to assess how their risk changes after surgery and throughout surveillance," said Yoshiaki Nakamura, M.D., Ph.D., a co-lead author of the study. "These results show that ctDNA detection using a tissue-free assay was associated with a substantially increased risk of recurrence and melanoma-related death and often preceded clinical detection of disease."

Kenjiro Namikawa, M.D., Ph.D., another author, noted that "further studies will be important to determine whether and how ctDNA results could be incorporated into postoperative treatment and surveillance decisions."

The COSMOS program is a prospective initiative evaluating MRD detection with Guardant Reveal across six cancer types. COSMOS-MEL01 is described by the company as the first published prospective, multicenter evaluation of the tissue-free test in melanoma.

Guardant Reveal is currently cleared for MRD detection and recurrence monitoring in early-stage colorectal, breast, and lung cancers. Melanoma is not among its current cleared indications.

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