Enrollment Begins in FORESEE Clinical Trial Using Biocept’s CNSide™ to Evaluate Patients with Leptomeningeal Metastases
Biocept, Inc. (NASDAQ: BIOC) has initiated enrollment for its FORESEE clinical trial, starting with the first patient at UT Southwestern Medical Center. The trial aims to include 40 patients with breast or non-small cell lung cancer who have leptomeningeal metastases. It evaluates the performance of CNSide, a proprietary cerebrospinal fluid assay, in monitoring treatment responses and informing clinical decisions. Current diagnostic methods have limited sensitivity, highlighting the need for this innovation. The trial results could significantly impact treatment strategies for these patients.
- First patient enrolled in the FORESEE trial, indicating progress in clinical research.
- CNSide assay designed to improve monitoring of leptomeningeal metastases.
- Collaboration with a respected institution, enhancing credibility.
- None.
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
“The enrollment of the first patient in the FORESEE clinical study is a major milestone for the management of patients with leptomeningeal disease,” 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,” said
About CNSide
Using our proprietary CNSide™ assay to analyze and interrogate CSF-TCs and cfDNA for certain biomarkers, physicians can be better informed about the actionable molecular information associated with a patient’s metastatic cancer and develop a personalized cancer treatment plan. Through CNSide™, Biocept’s test menu focuses on cancer biomarkers that are clinically actionable based on clinical treatment guidelines listed by the National Comprehensive Cancer Network® (NCCN®). For more information, please visit https://biocept.com/technology/.
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This press release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to be correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," “goal,” or "project," or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this press release are not strictly historical, including, without limitation, statements regarding the potential strategic alternatives the company is exploring and any potential enhancement of shareholder value or other benefit to the company’s shareholders; the company’s projected year-end cash position; the potential preservation or extension of the company’s cash runway; the potential of CNSide; opportunities for CNSide; and other statements that are not historical fact, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risks and uncertainties, including risks related to preliminary financial results as described above, risks related to the company’s business, market risks, our need for additional capital, and the risk that our products and services may not perform as expected. These and other factors are described in greater detail under the "Risk Factors" heading of Biocept’s Quarterly Report on Form 10-Q for the quarter ended
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