NEW YORK – Natera said on Thursday that it is launching a new study, called BESPOKE CRC, for its Signatera cell-free DNA blood test in colorectal cancer patients.
The nationwide multi-center prospective registry study aims to measure the clinical impact of serial testing with Signatera in patients with stage II or stage III colorectal cancer. The test is designed for molecular residual disease assessment, early relapse detection, and patient risk stratification after surgery.
The goal is to enroll at least 1,000 patients at the time of surgery and to perform Signatera multiple times in the first six months after surgery to help assess the need for adjuvant chemotherapy. After that, the test will be used about every three months for surveillance to detect relapse early.
The study will begin enrollment early this year and plans to follow patients for up to two years. It is expected to be completed in 2023.
"Signatera offers a tremendous opportunity to reduce unnecessary treatment and improve long-term outcomes in patients with early-stage colorectal cancer," said Alexey Aleshin, Natera's senior medical director of oncology, in a statement. "We believe the BESPOKE study will help establish basic clinical protocols that will eventually become the standard of care worldwide."
Last May, the US Food and Drug Administration granted Natera breakthrough device designation for Signatera for use in certain cancer patients.
Also, last August, Medicare administrative contractor Palmetto released a draft local coverage determination for Signatera, proposing to cover the test for certain patients with stage II or stage III colorectal cancer.
The Signatera test is custom-designed for each patient. It detects 16 tumor-specific genetic variants in cell-free DNA, which are previously determined by exome sequencing of tumor tissue and matched normal blood.