Biocept Expands Commercial Offering of CNSide™ Assay to Most Cancers that Metastasize to the Central Nervous System
October 17 2022 - 08:00AM
Business Wire
The cerebrospinal fluid (CSF) assay is now
validated for melanomas and carcinomas, providing information to
help physicians improve treatment decisions for more patients with
advanced cancers
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products, and services, 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. 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.
About Biocept
Biocept, Inc. develops and commercializes molecular diagnostic
assays that provide physicians with clinically actionable
information for treating and monitoring patients diagnosed with a
variety of cancers. For more information, visit www.biocept.com.
Follow Biocept on Facebook, LinkedIn, Twitter, and Instagram.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements that are
based upon current expectations or beliefs, as well as a number of
assumptions about future events. Although we believe that the
expectations reflected in the forward-looking statements and the
assumptions upon which they are based are reasonable, we can give
no assurance that such expectations and assumptions will prove to
be correct. Forward-looking statements are generally identifiable
by the use of words like "may," "will," "should," "could,"
"expect," "anticipate," "estimate," "believe," "intend," “goal,” or
"project," or the negative of these words or other variations on
these words or comparable terminology. To the extent that
statements in this press release are not strictly historical,
including, without limitation, statements regarding our ability to
establish CNSide as the new standard-of-care diagnostic test for
patients with metastatic cancer that has spread to the central
nervous systems, and the ability of our products, including CNSide,
to provide physicians with clinically actionable information for
treating and monitoring patients diagnosed with a variety of
cancers, such statements are forward-looking, and are made pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. The reader is cautioned not to put undue
reliance on these forward-looking statements, as these statements
are subject to numerous risks and uncertainties, including risks
and uncertainties associated with the ability of our products to
compete successfully with competitive products or treatments; our
ability to obtain and maintain adequate reimbursement for our
products; and the risk that our products and services may not
perform as expected. These and other factors are described in
greater detail under the "Risk Factors" heading of Biocept’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2022,
filed with the SEC on May 23, 2022. The effects of such risks and
uncertainties could cause actual results to differ materially from
the forward-looking statements contained in this press release. We
do not plan to update any such forward-looking statements and
expressly disclaim any duty to update the information contained in
this press release except as required by law. Readers are advised
to review our filings with the SEC at http://www.sec.gov/.
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