Biocept Inc (NASDAQ:BIOC) revealed that it has expanded the commercial availability of CNSide, which is based on its proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets, to patients with metastatic melanoma.
Previously validated for lung, breast, and all other carcinomas, the San Diego, California-based company’s CNSide is a proprietary cerebrospinal fluid (CSF) assay designed to better detect metastatic cancers involving the central nervous system (CNS).
Biocept said that its new CNSide for melanoma assay uses a “novel antibody cocktail” optimized for the capture of melanoma cells based on unique cellular characteristics. The assay is a "significant development" in the field of neuro-oncology related diagnostics, according to Biocept. 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. Biocept revealed that combined, the features help clinicians answer three key questions for patients with CNS metastasis:
- Is there a 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 lab developed test," said Michael Dugan, who is the chief medical officer and medical director at Biocept.
"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."
Meanwhile, Biocept interim president and CEO Samuel D Riccitelli noted that the company is “pleased” to expand the commercial use of CNSide for physicians treating patients with metastatic melanoma.
"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," he added.
Biocept is a provider of molecular diagnostic assays, products, and services.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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