28 March 2023 - - The first patient in the FORESEE clinical trial with US-based molecular diagnostic assays, products and services provider Biocept, Inc's (NASDAQ: BIOC) proprietary cerebrospinal fluid assay CNSide (NCT05414123), the company said.

This first patient was seen at the UT Southwestern Medical Center, one of the largest and most respected hospitals in the nation.

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.

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 that is used commercially at the physician's discretion, with samples processed in Biocept's CLIA-certified, CAP-accredited laboratory.


Using our proprietary CNSide assay to analyze and interrogate CSF-TCs and cfDNA for certain biomarkers, physicians can be better informed about the actionable molecular information associated with a patient's metastatic cancer and develop a personalized cancer treatment plan.

Through CNSide, Biocept's test menu focuses on cancer biomarkers that are clinically actionable based on clinical treatment guidelines listed by the National Comprehensive Cancer Network (NCCN).

Biocept is a molecular diagnostics company with commercialized assays for patients with carcinomas or melanomas. Our experts have spent years working to change the way physicians look at cerebrospinal fluid in cancer patients.

Biocept has developed a unique, patented methodology to isolate cancer material that is shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and cell-free DNA (cfDNA).

As such, Biocept is a leading commercial provider of testing services designed to enable clinicians to rapidly detect and monitor cancer biomarkers from a cerebrospinal fluid sample.