Battling cancer is often a long journey—and one that becomes even more challenging for the large number of patients who find that the cancer may have spread to their brain or spinal cord.

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Between 10% and 30% of cancer patients, and a much higher percentage of late-stage cancer patients will develop brain or spinal cord metastasis. There are an estimated 150,000 to 200,000 brain metastases annually in the U.S. alone. The top two cancers involved in brain metastases are lung (50%) and breast (15%). Overall survival rates are low, and many patients are not diagnosed early enough to allow time for effective treatment. However, newer targeted therapies may extend survival for a year or more, resolving symptoms and substantially improving quality of life.

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Patients who have been previously treated for lung cancer, breast cancer or melanoma, among others, may have systemic control of their disease yet ominously present with vague neurologic symptoms or radiologic features of suspected CNS involvement as the sole remaining evidence of cancer.

 

Looking Through a New Lens

Biocept (NASDAQ: BIOC) is one of the only molecular diagnostic companies focused on cerebrospinal fluid rather than blood. The company’s core technology looks at tumor cells in the cerebrospinal fluid, or CSF, as well as what's known as tumor-derived cell-free DNA, or tumor DNA. Biocept found that this combined approach is most informative, particularly when tumors have spread to the central nervous system.

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During a pharmaceutical trial, Biocept dicsovered that its proprietary technology, initially used in blood, is highly effective at analyzing CSF to identify cancer that has metastasized to the brain and spinal cord. The principal investigator for the trial said, “You don't know what you have. What your test provides is something I can’t get anywhere else.” This discovery led Biocept to validate and launch its CNSide™ CSF assay.

 

CNSide is based on Biocept’s quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. It also uses a proprietary sample collection tube, which preserves the CSF tumor cells.

 

CNSide addresses a high unmet clinical need, as metastatic brain cancer is extremely difficult to accurately diagnose using traditional tools and approaches. The assay offers significant advantages over the current standard of care and answers three primary clinical questions for physicians:

• Is there a tumor involving the central nervous system?

• Is there a target or a biomarker that can be used for therapy selection?

• Is there a trend? Are we seeing a measurable response to therapy over time that can inform either the continuation or the discontinuation of the treatment?

 

The ability to utilize CNSide, combined with newer therapies that target specific cancer mutations, provides physicians with increased ability to help patients who have limited options and limited time.

 

“Simply stated, patients diagnosed with advanced cancer and their physicians need better tools to diagnose brain metastasis earlier, more accurately, and to assess response to therapy in a timely, quantitative fashion so that patients can benefit from the remarkable advances in cancer therapies available today,” said Michael Dugan, MD, Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. “These patients do not have time to waste on inaccurate or uncertain diagnostic tests.”

 

Road to Adoption

Initial acceptance by neuro-oncology thought-leaders is highly encouraging, as physicians from more than three dozen leading academic institutions have ordered CNSide—with the majority becoming repeat users. These physicians have observed marked reductions in tumor cell counts in patients treated with targeted therapies, with corresponding improvements in symptoms and survival times. During a key opinion leader webinar hosted by Biocept, neuro-oncologists from leading institutions stated that CNSide provides information that goes well beyond what can be obtained from current diagnostics—specifically, it provides insights to help oncologists select the right treatment for patients and monitor treatment response.

 

“Neuro-oncology is a large and growing market for Biocept that we estimate at more than $1 billion annually in the U.S. for breast and lung cancers that have metastasized to the central nervous system,” said Michael Nall, Biocept’s President and CEO. “We believe CNSide represents a significant advance in the care of patients with brain metastases and in the evolution of Biocept.”