Biocept has announced recruitment of the first patient in the FORESEE clinical trial of its proprietary cerebrospinal fluid assay CNSide in patients with breast or non-small cell lung cancer (NSCLC) with suspected or confirmed leptomeningeal metastases (LM).
The US-based molecular diagnostics company said that CNSide is intended to analyse and interrogate cerebrospinal fluid tumour cells (CSF-TCs) and cell-free DNA (cfDNA) for certain biomarkers.
According to Biocept, the first patient was enrolled at the UT Southwestern Medical Center in Dallas.
The FORESEE trial is a multicentre clinical trial that aims to enrol 40 patients with NSCLC and leptomeningeal metastases.
The clinical trial is intended to assessing the effectiveness of the CNSide test in tracking the leptomeningeal metastases’ reaction to treatment. It is also aimed to study the impact of the assay on the treatment choices made by doctors.
FORESEE trial principal investigator Priya Kumthekar 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.”
Biocept said that the CNSide is a laboratory developed test (LDT) with samples processed in the company’s CLIA-certified, CAP-accredited laboratory. The assay is commercially utilised at the discretion of physicians.
Biocept chairman and interim president and CEO Sam Riccitelli said: “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.
“The test can be used to detect the presence of tumour, as well as guide and monitor therapy, an area of critical need for these terminally ill patients.”
By using the CNSide assay, physicians can receive better information about the actionable molecular information pertaining to a patient’s metastatic cancer, the US-based diagnostic firm claimed. The assay will help develop a customised cancer treatment plan.
