eClinical Technology and Industy News

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

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–Mar. 24, 2023– Biocept, Inc. (Nasdaq: BIOC), 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 (NCT05414123). 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 (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.

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