On September 21, 2023 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported the full enrollment of 40 subjects with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed leptomeningeal metastases (LM) in the feasibility phase of its prospective FORESEE clinical trial (NCT0414123) (Press release, Biocept, SEP 21, 2023, View Source [SID1234635329]). This trial is evaluating the performance of Biocept’s proprietary CNSide assay in monitoring the response to therapy of LM, a cancer in the membranes that surround the brain and spinal cord, and assessing its impact on treatment decisions made by physicians.
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"Early adoption and reorder rates are encouraging and suggest that neuro-oncologists are finding the information generated by CNSide as useful in managing patients with this devastating cancer."
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"Completing enrollment in this first phase of our FORESEE trial, and doing so ahead of our internal timeline, is significant as we work toward establishing CNSide as standard of care under the National Comprehensive Cancer Network, or NCCN, guidelines," said Antonino Morales, Biocept President and CEO. "We believe obtaining standard-of-care status is the best path forward to support further physician adoption and to set reimbursement at a rate that reflects the value of our test in the clinical decision making process. The FORESEE trial is specifically designed to measure the impact of CNSide on physicians’ clinical decisions to generate the data needed to help us reach this goal.
"Our CNSide assay is the first commercially available method that has the potential to objectively measure the presence of tumor in the central nervous system (CNS), as well as help guide and monitor therapy, an area of critical need for these terminally ill patients," he added. "Early adoption and reorder rates are encouraging and suggest that neuro-oncologists are finding the information generated by CNSide as useful in managing patients with this devastating cancer."
FORESEE is a two-part prospective clinical trial designed to follow subjects and collect data from each enrollee at four key time points in their treatment, as well as to compare CNSide cell detection in the cerebrospinal fluid to that of conventional cytology. CNSide has notable advantages over current standards of care, such as cytology, clinical evaluation and MRI, which have limited sensitivity and specificity. In retrospective pilot studies, CNSide demonstrated 92% sensitivity and 95% specificity in detecting LM. Additionally, CNSide is both qualitative and quantitative, which are key to monitoring treatment response and improving the ability of physicians to make or change treatment decisions.
"The current standards of care can present a significant obstacle in patient care due to the limitations in the detection and monitoring of LM. In addition to the current methods, there is a need for a reliable tool to diagnose and to monitor response to treatments in patients with LM," said Jonathan Yang, MD, PhD at the University of Washington and principal investigator at this site of the FORESEE trial. "In my practice I’ve found that CNSide provides important information that augments the detection and monitoring of LM, which is becoming increasingly important as patients with LM are living longer with improved quality of life due to improvement in treatments."
Biocept expects to have results from the feasibility phase of the FORESEE trial in the first half of 2024 and to then begin enrolling between 40 and 100 subjects in the trial’s validation phase. Enrollment is currently open at four clinical sites with two additional sites expected to join the FORESEE trial in the near term.
About CNSide
CNSide is a laboratory developed test (LDT) based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to monitor the response to therapy more effectively than other current methods.