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TEST:
CNSide™ Cerebrospinal Fluid Assay

Company:
Biocept
Type:
Laboratory Developed Test
Related tests:
Evidence

News

13d
Plus Therapeutics Provides Highlights Regarding Leptomeningeal Metastases Acquisition and Topline Clinical Trial Data on the FORESEE Trial (GlobeNewswire)
"Company acquired assets for the synergistic leptomeningeal metastases (LM) diagnostic platform, 'CNSide' and discussed potential partnering opportunities....Plus presented topline clinical trial data from the FORESEE trial which met its primary endpoint of clinical utility for the CNSide test in 40 patients with LM due to either breast or non-small cell lung cancer; a presentation of the full analysis is planned for the August 8-10 SNO/ASCO Meeting in Denver, CO."
Licensing / partnership
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CNSide™ Cerebrospinal Fluid Assay
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RNL (rhenium (186Re) obisbemeda)
3ms
Prognostic value of cerebrospinal fluid tumor cell count in leptomeningeal disease from solid tumors. (PubMed)
CSF-TC density may carry prognostic value in patients with LMD from solid tumors. Integrating CSF-TC density into LMD patient risk-stratification may help guide treatment decisions.
Journal • Tumor cell
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CNSide™ Cerebrospinal Fluid Assay
4ms
Keeping a track on leptomeningeal disease in non-small cell lung cancer: A single-institution experience with CNSide. (PubMed, Neurooncol Adv)
The median survival for LMD patients was 16.1 m (5.2-NR). We show that CNSide can supplement the management of LMD in conjunction with SOC methods for the diagnosis, monitoring response to therapy, and identifying actionable mutations unique to the CSF in patients with LMD.
Journal
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CNSide™ Cerebrospinal Fluid Assay
6ms
Comparative evaluation of the diagnostic and prognostic performance of CNSideâ„¢ versus standard cytology for leptomeningeal disease (SNO 2023)
This retrospective, single-institution, real-world analysis of CNSideâ„¢ showed increased sensitivity versus cytology and provided clinically relevant, cell-based molecular CSF analyses.
Cytology
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HER-2 (Human epidermal growth factor receptor 2)
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CNSide™ Cerebrospinal Fluid Assay
6ms
A Longitudinal Therapy Response Monitoring Study in Subjects with Leptomeningeal Metastases using CNSide Compared to Standard of Care (CSF Cytology, Clinical Evaluation, Imaging) (SNO 2023)
Physicians will also indicate which component of the test aided in management, modeling other similar studies that measure the effect of serum biomarker results on clinical management of cancer. Secondary end points include diagnostic comparison to clinical evaluation, cytology, and radiographic results, and determining the sensitivity, specificity, PPV and NPV of CNSide in the detection of CSF tumor cells (cytology being the reference standard).
Clinical • Cytology
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CNSide™ Cerebrospinal Fluid Assay
7ms
Excellent Response to Trastuzumab Deruxtecan in "HER-2 Low" Leptomeningeal Breast Cancer and Diagnostic and Monitoring Utility of CNSide Assay (SABCS 2023)
She had been taking adjuvant letrozole at the time of presentation. This case also highlights the benefits of using advanced and highly sensitive CSF assays to diagnose and surveil leptomeningeal disease and to assess HER2 signaling. This case is well-timed especially in the era of next-generation, CNS penetrating, potent HER2-directed antibody-drug conjugate like T-DXd which can mount antitumor activity even with minimal HER2 expression in tumors.
PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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PD-L1 expression • ER positive • HER-2 amplification • HER-2 negative • HER-2 expression • PD-L1 negative • ER negative • PD-L1 expression + HER-2 overexpression
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CNSide™ Cerebrospinal Fluid Assay
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Enhertu (fam-trastuzumab deruxtecan-nxki) • letrozole
7ms
Comparison of next-generation sequencing (NGS) results from the cerebrospinal fluid, peripheral blood, and systemic metastatic tumor tissue of patients with metastatic breast cancer (MBC) and leptomeningeal disease (LMD) (SABCS 2023)
We observed concordance and heterogeneity in the status of actionable mutations between the CSF, peripheral blood, and systemic metastatic tumor tissue. Larger studies are needed to assess the clinical utility of these observations, particularly with the development of several novel targeted agents that are CNS-penetrant.
Clinical • Next-generation sequencing • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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TP53 mutation • HER-2 amplification • HER-2 negative • PIK3CA mutation • HER-2 mutation • ER Y537S • PIK3CA E542K • PIK3CA E545 • PIK3CA E542 • TP53 R273H
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FoundationOne® CDx • Guardant360® CDx • CNSide™ Cerebrospinal Fluid Assay
8ms
Enrollment completed in the feasibility phase of the FORESEE clinical trial with Biocept’s CNSide™ assay to evaluate patients with leptomeningeal metastases (Biocept Press Release)
"Biocept...announces 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). 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."
Enrollment closed
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CNSide™ Cerebrospinal Fluid Assay
9ms
Biocept Signs CNSide Licensing Agreement with Plus Therapeutics (Businesswire)
"Biocept, Inc...announces the signing of a non-exclusive licensing agreement for CNSide™ with Plus Therapeutics, Inc...which expands the comprehensive laboratory services agreement between the two companies that was announced in June 2022....This new agreement allows for Plus to perform CNSide testing during its clinical trials and commercially, subject to regulatory approval....Plus will pay Biocept an upfront fee of $150,000 in stock, plus $6,000 per CSF tumor cell enumeration analysis performed in Biocept’s CLIA-certified and CAP-accredited laboratory prior to the completion of the technology transfer. Once the technology transfer is complete, Plus will pay Biocept $300,000 plus fees on a sliding scale starting at $2,800 for each CNSide test they perform. The license agreement also gives Plus the option to negotiate for third-party exclusivity with a $1,000,000 payment to Biocept."
Licensing / partnership
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CNSide™ Cerebrospinal Fluid Assay
9ms
Biocept’s CNSide™ Cerebrospinal Fluid Assay featured in two oral presentations at the 2023 SNO/ASCO CNS cancer conference (Biocept Press Release)
"Biocept...announces that its CNSide cerebrospinal fluid assay was featured in two oral presentations at the 2023 SNO/ASCO CNS Cancer Conference on Saturday, August 12."
Clinical data
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CNSide™ Cerebrospinal Fluid Assay
12ms
Scientific poster presented at the 2023 ASCO annual meeting highlights performance of Biocept’s CNSide™ versus cytology (Biocept Press Release)
"Biocept...announces a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting underway in Chicago showing the ability of CNSide™ to detect rates of leptomeningeal metastases (LM) compared with standard CSF cytology from lumbar puncture. The poster, titled 'Evaluating the diagnostic performance of leptomeningeal diagnosis with CNSide compared to standard cytology,' was presented by Dr. Haley Appel at the Miami Cancer Institute, Baptist Health South Florida, on Saturday, June 3. The abstract of the poster is available here, including a link to the full poster which is accessible to ASCO registrants."
Clinical data
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CNSide™ Cerebrospinal Fluid Assay
1year
Evaluating the diagnostic performance of leptomeningeal diagnosis with CNSide compared to standard cytology. (ASCO 2023)
In the largest, retrospective, single institution, real-world study, implementation of CNSide showed increased sensitivity relative to standard cytology and increased specificity relative to EANO criteria, and provided clinically relevant, cell-based molecular and cell-free DNA analyses. CNSide increased the diagnostic yield by 56.5%.
Cytology
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HER-2 (Human epidermal growth factor receptor 2)
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CNSide™ Cerebrospinal Fluid Assay
1year
Enrollment begins in FORESEE clinical trial using Biocept’s CNSide™ to evaluate patients with leptomeningeal metastases (Biocept Press Release)
"Biocept...announces enrollment of the first patient in the FORESEE clinical trial with the Company’s proprietary cerebrospinal fluid assay CNSide (NCT05414123). This first patient was seen at the UT Southwestern Medical Center, one of the largest and most respected hospitals in the nation."
Enrollment open
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CNSide™ Cerebrospinal Fluid Assay
over1year
Biocept announces participation in an investigator-initiated study to better understand the development and progression of metastatic breast cancer to the central nervous system (Biocept Press Release)
"Biocept...announces a collaboration agreement to participate in an investigator-initiated, non-therapeutic pilot study to evaluate the cerebrospinal fluid tumor and immune cell microenvironment in patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease. The study is designed to identify biomarkers associated with central nervous system (CNS) metastasis, enabling a better understanding of treatment response, prognosis, and treatment resistance that may improve the management of CNS disease in patients with metastatic breast cancer...Results from cerebrospinal fluid using Biocept’s CNSide assay and matched patient blood samples will be analyzed and compared to detect and characterize cancer in the cerebrospinal fluid with the goal of identifying new targets and to guide therapeutic decisions."
Licensing / partnership • Clinical
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CNSide™ Cerebrospinal Fluid Assay
over1year
Biocept expands commercial offering of CNSide™ assay to most cancers that metastasize to the central nervous system (Biocept Press Release)
"Biocept, Inc...announces the expanded commercial availability of CNSide for patients with metastatic melanoma. Previously validated for lung, breast, and all other carcinomas, Biocept’s CNSide is a proprietary CSF assay designed to better detect and inform treatment decisions for patients with metastatic cancers involving the central nervous system (CNS)...The new CNSide for melanoma assay uses a novel antibody cocktail optimized for the capture of melanoma cells based on unique cellular characteristics."
Commercial
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CNSide™ Cerebrospinal Fluid Assay
over1year
Biocept to host key opinion leader webinar on october 14 to discuss its proprietary CNSide™ assay to detect and quantify cancer that metastasized to the central nervous system (Biocept Press Release)
"Biocept, Inc...announces an hour-long webinar to be held October 14 at 1 p.m. Eastern time featuring case studies presented by leading neuro-oncologists who have used the company’s CNSide assay in the management of patients with confirmed or suspected central nervous system metastasis."
Clinical data
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CNSide™ Cerebrospinal Fluid Assay
almost2years
Plus Therapeutics and Biocept Announce Comprehensive Laboratory Services Agreement for the ReSPECT-LM Trial (GlobeNewswire)
"Plus Therapeutics, Inc...and Biocept, Inc...announce a multi-year agreement to employ Biocept’s cerebrospinal fluid (CSF) assay CNSide1 in Plus Therapeutics’ ReSPECT-LM Phase 1/2a dose-escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of patients with leptomeningeal metastases (LM), which is cancer in the membranes that surround the brain and spinal cord."
Licensing / partnership
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CNSide™ Cerebrospinal Fluid Assay
|
RNL (rhenium (186Re) obisbemeda)
2years
Biocept presentation at Molecular Medicine Tri-Con meeting highlights potential of CNSide™ Assay to support development of targeted therapies for metastatic brain cancer (Biocept Press Release)
"Biocept, Inc...highlighted the ability of its CNSide™ cerebrospinal fluid (CSF) assay to aid in therapeutic research programs for metastatic brain cancer in a presentation at the Molecular & Precision Med Tri-Con meeting. The company is also exhibiting (booth #508) at the conference, which is the leading international meeting for the precision medicine community, Feb. 21-23, 2022, in San Diego."
Clinical data
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CNSide™ Cerebrospinal Fluid Assay
over2years
Biocept’s CNSide Cerebrospinal Fluid Assay identifies actionable HER2 mutations in patients with breast cancer that has metastasized to the brain (Biocept Press Release)
"Biocept, Inc...presented a study demonstrating the ability of its CNSide™ assay to identify HER2 and other actionable tumor alterations in the cerebrospinal fluid of patients with breast cancer and leptomeningeal disease (LMD). The poster was chosen for a Spotlight Presentation at the San Antonio Breast Cancer Symposium on Dec. 8, 2021."
Clinical data
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CNSide™ Cerebrospinal Fluid Assay
over2years
Biocept’s CNSide Cerebrospinal Fluid Assay aids in monitoring treatment response and detects actionable biomarkers in patients with metastatic breast cancer (Biocept Press Release)
"Biocept...announced the presentation of a multi-institutional case series showing that its CNSide™ cerebrospinal fluid assay helps physicians monitor treatment response and detects actionable mutations in patients with metastatic breast cancer and leptomeningeal disease (LMD). The poster will be presented virtually at the Society for Neuro-Oncology Annual Meeting...At diagnosis, CNSide detected cancer cells in three of three patients, compared with two of three patients for cytology. (The fourth patient was diagnosed before CNSide was available.) CNSide detected CSF tumor cells in all eleven measurements taken, compared to six of eleven using cytology. Throughout treatment, CNSide showed a decrease in CSF tumor cells in all four patients, ranging from 99.7% to 100%, corresponding with an improved clinical response."
Clinical data
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CNSide™ Cerebrospinal Fluid Assay
over2years
Case series of multi-institutional utility of CNSide to manage Leptomeningeal Disease in patients with metastatic breast cancer (SNO 2021)
Our experience suggests that using CNSide for quantitative CSF tumor cell detection may aid in diagnosing LMD, as well as in quantifying response to treatment particularly in the setting of intrathecal therapy. However, larger prospective clinical trials are needed to establish the role of CNSide in the diagnosis and management of LMD.
Clinical
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CNSide™ Cerebrospinal Fluid Assay
over2years
Characterization of HER2 amplification in the cerebrospinal fluid of patients with Leptomeningeal Disease in stage IV patients with breast cancer (SABCS 2021)
HER2 amplification is frequently found in breast cancer patients with LMD and can be reliably detected in tumor cells isolated from CSF. Evaluation of HER2 status in CSF-TCs allows treating physicians the opportunity to rapidly confirm the presence of this biomarker and select a more effective targeted therapy against HER2 in patients who present with life-threatening complications of breast cancer. Additional studies are needed to fully establish the clinical utility of CNSide when using various anti-HER2 therapies or therapy combinations to treat breast cancer patients with LMD.
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
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HER-2 amplification
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CNSide™ Cerebrospinal Fluid Assay