NEW YORK – Guardant Health on Tuesday said it has begun a prospective study evaluating the ability of its Reveal liquid biopsy test to predict which cancer patients will experience disease recurrence despite receiving treatment that is intended to cure them.
The study, called Observation of Residual Cancer with Liquid Biopsy Evaluation, or ORACLE, will involve 1,000 patients with 11 kinds of early-stage tumors. The three primary cohorts will include patients with invasive bladder, ureteral, or renal pelvis cancer; stage II to III non-small cell lung cancer; and breast cancer with residual invasive disease after neoadjuvant chemotherapy. Researchers will also enroll several exploratory cohorts of patients with cutaneous melanoma, and esophageal, gastroesophageal junction, gastric, pancreatic, ovarian, endometrial, renal cell, and head and neck tumors.
In ORACLE, researchers will use the Reveal test to analyze circulating tumor DNA in early-stage cancer patients after they received treatment and during routine follow-up for up to five years. The primary endpoint is distant recurrence-free survival. The test may also help identify patients who could benefit from adjuvant treatment after surgery.
Guardant launched Reveal earlier this year, and the test was approved by the New York State Department of Health in April to detect residual disease and monitor for recurrence in colorectal cancer patients. There are three ongoing studies evaluating Reveal's ability to detect minimal residual disease and recurrence in early-stage and metastatic colon cancer.
Guardant co-CEO Helmy Eltoukhy expects that data from ORACLE will allow the company to expand the Reveal recurrence monitoring test's use beyond early-stage colorectal cancer and into other tumor types. "We believe our blood-only test can be a powerful and streamlined decision-making tool for oncologists managing patients with early-stage cancers," Eltoukhy said in a statement.