Natera Inc. (NTRA), a diagnostics and precision medicine company, on Thursday reported enrollment of the first patient in the SIGNAL-ER 101 study for Signatera MRD tests to facilitate diagnosis and directed treatments in early-stage breast cancer.
Signatera is an assay test developed to detect circulating DNA (ctDNA) to identify minimal residual disease (MRD). Patients of intermediate-risk, HR+/HER- early-stage breast cancer are usually treated with a combination of CDK4/6 inhibitors and endocrine therapy, but these yield benefit in only 3% of cases.
However, upon identification of MRD negative status, patients can defer CDK4/6 inhibitor treatment in favor of endocrine therapy, which shows a 95% recurrence-free success rate.
The SIGNAL-ER 101 study plans to enroll 725 patients of early-stage breast cancer. If diagnosed as MRD negative via the Signatera test, the patient can be treated solely with endocrine therapy. In cases where a MRD negative patient later tests MRD positive, they will be eligible to initiate the CDK4/6 inhibitor dosing in combination with endocrine therapy.
The Signatera test has shown positive results in previous studies to identify MRD-negative bladder and colorectal cancers, affecting improvement in treatment outcomes.
NTRA is currently trading at $205.52, up 1.19%.
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