A U.S. Observational, Prospective Study
The FORESEE Study is a longitudinal therapy response monitoring study in subjects with leptomeningeal metastases using CNSide™ (CSF Tumor Cells) compared to standard of care (CSF cytology, clinical evaluation, and imaging).
A multi-center, prospective clinical trial enrolling patients with breast or non-small cell lung cancer (NSCLC) who have suspected or confirmed leptomeningeal metastases (LM). Standard of care methods to diagnose or assess the treatment response of LM (clinical evaluation, MRI, and cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. CNSide can detect and quantify tumor cells in the CSF from patients with breast cancer or NSCLC who have suspected or confirmed LM. CNSide is a Laboratory Developed Test (LDT) that is used commercially at the physician’s discretion in Biocept’s CLIA certified, CAP accredited laboratory.
The goal of the FORESEE Study is to evaluate the performance of CNSide in monitoring the response of leptomeningeal metastases (LM) to treatment and to assess the impact of CNSide on treatment decisions made by physicians.