Molecular assay provides highly sensitive,
quantitative method to identify cancer involving the central
nervous system, inform treatment decisions, and monitor therapy
response
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, has announced the full
commercial launch of CNSide™, its cerebrospinal fluid (CSF) assay
designed to better detect and manage treatment of metastatic
cancers involving the central nervous system (CNS). The assay,
initially introduced in January 2020, has the ability to offer a
timely and accurate method to diagnose disease, identify actionable
biomarkers, and assess response to therapy, potentially impacting
life expectancy and quality of life.
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CNSide is based on Biocept’s proprietary quantitative tumor cell
capture and detection method paired with assays to identify
actionable molecular treatment targets. The assay answers three key
questions: Is there involvement by tumor? Is there a target for
treatment? Is there a trend with respect to treatment response?
The CNSide assay addresses a high unmet clinical need, as the
current standard of care, CSF cytology, has limited sensitivity for
detecting brain metastasis and assessing therapy response, and does
not provide quantitative results. Between 10% and 30% of patients
with cancer, depending on cancer type, will develop brain or spinal
cord metastasis. Overall survival expectancy is low, and many
patients are not diagnosed early enough for therapeutic
intervention. However, the use of newer targeted therapies for lung
and breast cancer with intracranial metastasis can often extend
survival for a year or more, resolving symptoms and substantially
improving quality of life.
“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.”
“CNSide, with Target Selector™ technology, provides information
well beyond what we can obtain from current
diagnostics—specifically, it provides insights to help us select
the right treatment for our patients, as well as insights on
duration of therapy,” said Priya Kumthekar, MD, Associate Professor
of Neurology and Oncology, Northwestern University Feinberg School
of Medicine, during a recent key opinion leader webinar. “I see
CNSide as a way to improve diagnosis and monitoring of CNS
involvement in a patient population that represents a very high
unmet need, and a population that appears to be growing.”
“The full sales force launch of our CSF assay, along with new
branding, is an exciting next step toward our goal of establishing
CNSide as a new standard-of-care diagnostic test for cerebrospinal
fluid,” said Michael Nall, Biocept’s President and CEO. “Initial
acceptance by neuro-oncology early-adopters has been highly
encouraging as physicians from nearly two dozen leading academic
institutions have ordered CNSide—with many becoming repeat users.
This represents a significant market opportunity that we estimate
at more than $1 billion annually in the United States for breast
and lung cancers that have metastasized to the central nervous
system.”
In 2020, Biocept presented highly favorable results from pilot
studies with the assay at three major scientific meetings.1-3 The
studies showed that in approximately 80% of the cases of suspected
CNS involvement, tumor cells were detected using the CNSide assay,
compared with about 50% of cases examined by CSF cytology. The
assay is currently validated to identify metastatic cancers
originating in the lung and breast. Biocept plans to expand its CSF
testing menu for additional tumor types and biomarkers in the
future.
A recent webinar hosted by Biocept featured leading
neuro-oncologists discussing the use of the CNSide assay for
diagnosing and managing tumors that have metastasized to the CNS.
The webinar can be viewed here.
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. In addition to its broad portfolio of
blood-based liquid biopsy assays, Biocept has developed the CNSide™
cerebrospinal fluid assay that detects cancer that has metastasized
to the central nervous system. Biocept’s patented Target Selector™
technology captures and quantitatively analyzes CSF tumor cells for
tumor-associated molecular markers, using technology first
developed for use in blood. Biocept also is leveraging its
molecular diagnostic capabilities to offer nationwide COVID-19
RT-PCR testing to support public health efforts during this
unprecedented pandemic. For more information, visit
www.biocept.com. Follow Biocept on Facebook, LinkedIn and
Twitter.
Forward-Looking Statements Disclaimer
This news 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" or
"project," or the negative of these words or other variations on
these words or comparable terminology. To the extent that
statements in this news release are not strictly historical,
including, without limitation, statements as to the ability of
CNSide to impact life expectancy and quality of life, our ability
to establish CNSide as the new standard of care for the diagnosis
of patients with suspected cancer metastasis to the CNS, our
ability to expand our CSF testing menu for additional tumor types
and biomarkers in the future, and our ability 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 risk factors as set forth in our Securities and Exchange
Commission (SEC) filings. The effects of such risks and
uncertainties could cause actual results to differ materially from
the forward-looking statements contained in this news 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/.
- Fenn K, Singh V, Lee S, et al. Diagnosis of leptomeningeal
metastasis (LM) through identification of circulating tumor cells
(CTCs) in cerebrospinal fluid (CSF). J Clin Oncol. 2020; 38(15):
3567.
- Singh V, Fisher D, Berz D, et al. The next generation of
cerebrospinal fluid (CSF)-based molecular diagnostics: Improving
sensitivity and actionability in breast and lung cancer patients
with CNS involvement. J Clin Oncol. 2020;38(15): e14502.
- Berz D, Singh V, Camidge R, et al. Utility of Liquid Biopsy in
Diagnosis and Treatment Response in EGFR Mutant NSCLC Patients with
Leptomeningeal Involvement. IASLC Virtual Meeting. October 2020.
Presentation available online.
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Media Contact: Andrea Sampson, Sampson PR Group
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Investor Contact: Jody Cain, LHA Investor Relations
Jcain@lhai.com, 310-691-7100
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