The Guardant Reveal liquid biopsy test has shown potential in predicting disease recurrence in patients with stage II and higher colorectal cancer (CRC), based on data from the COSMOS study, which has been published in Clinical Cancer Research. This innovative epigenomic test, which identifies minimal residual disease (MRD) without the need for tissue samples, exhibited high specificity, achieving 98.2% in post-treatment samples from patients who showed no recurrence. The median lead time for detection was 5.3 months, with some detections extending as far as 28.7 months. Sensitivity was similarly high, recorded at 99.1% for patients with at least 16.4 months of follow-up. Importantly, the test did not require tissue samples for evaluation, enabling all patients to be assessed without the need for invasive procedures.
Dr. Yoshiaki Nakamura, a co-lead author from the National Cancer Hospital East in Japan, highlighted the advantages of the Guardant Reveal test in providing specific and sensitive MRD detection without relying on tissue testing. He emphasised that using a tissue-free assay reduces logistical complexities and shortens the turnaround time, which is particularly advantageous for clinicians when making adjuvant treatment decisions.
Guardant Reveal holds the distinction of being the first tissue-free MRD detection test available for colorectal cancer, with applications extending to breast and lung cancer as well. By analysing over 20,000 epigenomic regions from a simple blood sample, the test accurately quantifies tumour fraction, delivering results in fewer than 10 days to support clinical decision-making in early-stage and post-surgery settings.
The COSMOS study, an ongoing observational study in Japan, recruited patients aged 20 and older with clinical stage 0 to III CRC who were planning surgical resection. Eligible participants had blood samples taken at intervals of 3 to 6 months post-surgery, up to a maximum of 5 years, or until recurrence, with concurrent CT scans conducted every 6 months. In this interim analysis, participants’ median age was 70, with women making up 44% of the cohort. Among the participants, 65% had CRC and 35% had rectal cancer, with most classified at pathologic stage II or III.
Additional data from COSMOS revealed a longitudinal sensitivity of 81% for recurrence detection in patients with stage II or higher colon cancer and 60% for those with stage II or higher rectal cancer. Sensitivity reached 100% in patients with liver metastases, although it was lower for those with lung or peritoneum metastases, at 53% and 40% respectively.
Dr. Craig Eagle, chief medical officer of Guardant Health, noted that the COSMOS study supports the Guardant Reveal test’s use in informing adjuvant therapy decisions and improving post-treatment surveillance, with earlier recurrence detection than standard practices.
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