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Columbia University Medical Center Sponsors Clinical Study Using Biocept’s Liquid Biopsy Platform to Evaluate Cerebrospinal Fluid of Breast Cancer Patients for Metastatic Biomarkers

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Biocept, Inc., a leading commercial provider of clinically actionable liquid biopsy tests designed to improve the outcomes of cancer patients, announces that Columbia University Medical Center will conduct a study to evaluate the clinical utility of the Company’s Target Selector™ platform to diagnose leptomeningeal metastases (LM) in patients with breast cancer.  LM occurs when tumor cells gain access to cerebrospinal fluid (CSF) pathways and regrow in distant sites within the spinal cord and brain leading to neurological complications. Biocept’s liquid biopsy platform will be used to test the CSF of breast cancer patients and will be compared to standard methods for confirming the diagnosis of LM.

“Diagnosing LM in patients with breast cancer can be challenging given the low diagnostic sensitivity of traditional methods such as cytologic analysis,” stated Kevin Kalinsky, MD, MS, Assistant Professor of Medicine, Columbia University Medical Center and the study’s principal investigator.  “We will be using Biocept’s Target Selector™ technology to evaluate oncologic biomarkers in the CSF of breast cancer patients, with the potential to provide a rapid and accurate solution to confirm diagnosis and enable patients to begin treatment for LM earlier. This clinical study addresses a significant medical need, given the devastating nature of LM involvement in breast cancer patients.”

The clinical trial is expected to enroll 46 patients with breast cancer who are undergoing lumbar puncture to detect the presence of LM. The primary study objective is to determine whether Biocept’s Target Selector™ circulating tumor cell (CTC) technology has higher sensitivity for the detection of LM, as compared to standard cytopathological analysis.  Secondary study objectives include the following:

  • Comparing each patient’s CTCs and cfDNA collected in CSF with blood samples.
  • Comparing the performance of Biocept’s Target Selector™ CTC platform to standard cytopathology in diagnosing LM within 2 subgroups: patients with LM confirmed by MRI and those with suspicious LM findings from MRI.
  • Exploring CTC and cfDNA levels from the CSF of patients with an initial negative LM finding using standard cytopathologic and CTC analysis.
  • Assessing the feasibility of determining estrogen, progesterone and HER2 receptor status on CTCs collected from CSF samples using Biocept’s Target Selector™ technology.
  • Assessing concordance between the receptor status of the primary and/or metastatic tumor and that of the LM cells collected using Biocept’s Target Selector™ technology.

“We are very pleased to again collaborate with Dr. Kalinsky and Columbia University Medical Center in this study designed to further validate the clinical utility of our Target Selector™ platform in order to improve the diagnosis and treatment of LM,” said Michael W. Nall, Biocept’s President and CEO.  “Among the significant advantages of our technology is its versatility, which enables applications in a variety of clinical situations and for use with multiple biofluids, potentially opening up future markets and expanded commercial opportunities.”

Source: PR Newswire