Biocept Inc (NASDAQ:BIOC), a provider of molecular diagnostic assays, products and services, revealed that the first patient with leptomeningeal metastases has been enrolled in the FORESEE clinical trial with the company’s proprietary cerebrospinal fluid assay CNSide (NCT05414123).
In a nutshell, leptomeningeal metastases, or LM, is cancer in your cerebrospinal fluid and membranes that surround your brain and spinal cord (the leptomeninges).
The San Diego, California-based molecular diagnostics company said the patient was seen at the UT Southwestern Medical Center, one of the largest and most respected hospitals in the US.
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 LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians, said Biocept.
Revolutionary technology
“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 Biocept Chairman and interim CEO Sam Riccitelli.
“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.”
Standard-of-care methods to diagnose and assess the treatment response of LM, which include MRI and cytology, have limited sensitivity and specificity. This creates challenges for physicians trying to manage LM or determine the best course of treatment. Biocept’s CNSide is a Laboratory Developed Test (LDT) that is used commercially at the physician's discretion, with samples processed in Biocept's CLIA-certified lab.
“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, 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, Associate Professor of Neurology and Medicine (hematology and oncology) at the Feinberg School of Medicine at Northwestern University is the principal investigator of the FORESEE trial.
“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,” said Dr Kumthekar.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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