On October 17, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products, and services, reported the expanded commercial availability of CNSide for patients with metastatic melanoma (Press release, Biocept, OCT 17, 2022, View Source [SID1234622076]). 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).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The new CNSide for melanoma assay uses a novel antibody cocktail optimized for the capture of melanoma cells based on unique cellular characteristics. This assay represents a significant development in the field of neuro-oncology related diagnostics. It is believed to be the first CLIA-validated assay designed for the quantitative identification of melanoma cells in CSF.
Melanoma is the third most common tumor type involved in CNS metastasis, with more than 60% of Stage IV melanoma patients developing CNS metastasis from their disease. Overall survival expectancy is low and patient management can be challenging due in part to diagnostic limitations. CNSide addresses a high unmet clinical need, as current standard of care approaches—CSF cytology and MRI imaging—have limited sensitivity for detecting CNS metastasis and are not adequate to assess the response to therapy. CNSide can also help identify molecular biomarkers considered targets for novel therapy approaches. Combined, these features help clinicians answer three key questions for patients with CNS metastasis: Is there tumor? Is there a target for treatment? Is there a trend or favorable response to treatment?
"Our early development experience evaluating patients with melanoma with CNSide is similar to what we have seen in carcinomas, supporting the expanded clinical use of this CLIA laboratory developed test," said Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "Physicians are finding CNSide valuable for managing patients with CNS metastasis, particularly to assess treatment response. Declining CSF tumor cell counts have correlated well with successful response to therapy and symptom resolution, while better illustrating residual, recurrent or resistant disease. CSF can also be more frequently and easily evaluated while the patient is in the clinic, compared to follow-up radiologic imaging that might occur weeks later."
"We are pleased to expand the commercial use of CNSide for physicians treating patients with metastatic melanoma," said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. "This is another step toward our goal of establishing CNSide as a new standard-of-care diagnostic test for patients with metastatic cancer that has spread to the CNS; patients who have no time to waste."
About CNSide
CNSide is 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 such as HER2 and EGFR 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.