Enrollment Begins in FORESEE Clinical Trial Using Biocept’s CNSide™ to Evaluate Patients with Leptomeningeal Metastases

27 March 2023

Biocept, Inc. a leading provider of molecular diagnostic assays, products and services, announces enrollment of the first patient in the FORESEE clinical trial with the Company’s proprietary cerebrospinal fluid assay CNSide. This first patie

The FORESEE trial is a multicenter, prospective clinical trial expected to enroll 40 patients with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed leptomeningeal metastases (LM). The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians.

Standard-of-care methods to diagnose or assess the treatment response of LM (i.e., 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 is a Laboratory Developed Test (LDT) that is used commercially at the physician's discretion, with samples processed in Biocept's CLIA-certified, CAP-accredited laboratory.

“The enrollment of the first patient in the FORESEE clinical study is a major milestone for the management of patients with leptomeningeal disease,” said Michael Youssef, MD, Assistant Professor in the Department of Neurology and the Department of Hematology and Oncology at UT Southwestern Medical Center. “We are excited to be at the forefront of this innovation, which will greatly benefit patients.”

Priya Kumthekar, MD, Associate Professor of Neurology and Medicine (hematology and oncology) at the Feinberg School of Medicine at Northwestern University and Principal Investigator of the FORESEE trial, said, “I am impressed by the ease of use and the versatility of the CNSide technology, and how it can facilitate disease diagnosis and management for our leptomeningeal patients who are truly in need of improved diagnostics and therapeutics.”

“The FORESEE trial evaluates the medical and clinical utility, when compared to standard of care, of the CNSide laboratory test, a revolutionary technology designed to detect cells in the cerebral spinal fluid of central nervous system brain metastasis patients,” said Sam Riccitelli, Chairman and interim President and CEO of Biocept. “The test can be used to detect the presence of tumor, as well as guide and monitor therapy, an area of critical need for these terminally ill patients.”

Dr. Kumthekar is a consultant to Biocept and Dr. Youssef has no financial interest in Biocept.