Molecular diagnostic assays provider Biocept has enrolled the first participant in the FORESEE clinical trial for CNSide, its cerebrospinal fluid assay.
The first participant was enrolled at the UT Southwestern Medical Center in Texas, US.
A total of 40 breast or non-small cell lung cancer (NSCLC) patients with suspicious or confirmed leptomeningeal metastases (LM) are expected to be enrolled in the trial.
The prospective, multicentre FORESEE trial has been designed to assess CNSide’s performance in tracking the response of LM to treatment, as well as the impact of the assay on doctors’ treatment decisions.
CNSide has been designed to analyse and assess cerebrospinal fluid tumour cells (CSF-TCs) and cell-free DNA (cfDNA) for certain biomarkers.
The Laboratory Developed Test (LDT) uses samples that are processed in Biocept’s clinical laboratory improvement amendments (CLIA)-certified and college of american pathologists (CAP)-accredited laboratory. The assay is used commercially at the physician’s discretion.
Biocept chairman, 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.”
The company stated that the CNSide assay can provide doctors with better information regarding the actionable molecular information associated with a patient’s metastatic cancer.
This will help healthcare professionals to develop a personalised cancer treatment plan.