SAN DIEGO, Dec. 27, 2016 /PRNewswire/ -- Biocept, Inc.
(NASDAQ: BIOC), a leading commercial provider of clinically
actionable liquid biopsy tests designed to improve the outcomes of
cancer patients, announces that Columbia
University Medical Center will conduct a study to evaluate
the clinical utility of the Company's Target Selector™ platform to
diagnose leptomeningeal metastases (LM) in patients with breast
cancer. LM occurs when tumor cells gain access to
cerebrospinal fluid (CSF) pathways and regrow in distant sites
within the spinal cord and brain leading to neurological
complications. Biocept's liquid biopsy platform will be used to
test the CSF of breast cancer patients and will be compared to
standard methods for confirming the diagnosis of LM.
"Diagnosing LM in patients with breast cancer can be challenging
given the low diagnostic sensitivity of traditional methods such as
cytologic analysis," stated Kevin
Kalinsky, MD, MS, Assistant Professor of Medicine,
Columbia University Medical Center and
the study's principal investigator. "We will be using
Biocept's Target Selector™ technology to evaluate oncologic
biomarkers in the CSF of breast cancer patients, with the potential
to provide a rapid and accurate solution to confirm diagnosis and
enable patients to begin treatment for LM earlier. This clinical
study addresses a significant medical need, given the devastating
nature of LM involvement in breast cancer patients."
The clinical trial is expected to enroll 46 patients with breast
cancer who are undergoing lumbar puncture to detect the presence of
LM. The primary study objective is to determine whether Biocept's
Target Selector™ circulating tumor cell (CTC) technology has higher
sensitivity for the detection of LM, as compared to standard
cytopathological analysis. Secondary study objectives include
the following:
- Comparing each patient's CTCs and cfDNA collected in CSF with
blood samples.
- Comparing the performance of Biocept's Target Selector™ CTC
platform to standard cytopathology in diagnosing LM within 2
subgroups: patients with LM confirmed by MRI and those with
suspicious LM findings from MRI.
- Exploring CTC and cfDNA levels from the CSF of patients with an
initial negative LM finding using standard cytopathologic and CTC
analysis.
- Assessing the feasibility of determining estrogen, progesterone
and HER2 receptor status on CTCs collected from CSF samples using
Biocept's Target Selector™ technology.
- Assessing concordance between the receptor status of the
primary and/or metastatic tumor and that of the LM cells collected
using Biocept's Target Selector™ technology.
"We are very pleased to again collaborate with Dr. Kalinsky and
Columbia University Medical Center in
this study designed to further validate the clinical utility of our
Target Selector™ platform in order to improve the diagnosis and
treatment of LM," said Michael W.
Nall, Biocept's President and CEO. "Among the
significant advantages of our technology is its versatility, which
enables applications in a variety of clinical situations and for
use with multiple biofluids, potentially opening up future markets
and expanded commercial opportunities."
About Leptomeningeal Disease in Breast Cancer
Leptomeningeal metastasis (LM) is a condition in which cancer
cells seed the meninges (nerve tissue in the spine and brain) and
may go on to invade the brain, spinal cord, cranial nerves or
peripheral nerves. It is a devastating complication of breast
cancer, and is often considered in the differential diagnosis when
patients with breast cancer present with new neurological symptoms.
It was previously thought to be a rare occurrence, but autopsy
series have shown the true overall incidence to be up to 8%. In
fact, while the incidence of meningeal metastasis in other cancers
has decreased, the opposite is true of breast cancer, in which the
clinical evidence suggests an increasing incidence.
Diagnosing LM can be difficult. The diagnosis is traditionally
based on CSF cytologic analysis, but more recently, MRIs of the
brain and spine are being used as first-line diagnostics because of
their noninvasive nature. However, MRI findings can be ambiguous,
and confirmatory findings may be difficult with cytopathologic
analysis. CSF cytopathologic analysis is used to provide diagnostic
confirmation of LM, but is associated with relatively low
sensitivity (~50% on the first lumbar puncture) and is highly
examiner dependent. Repeat multi-site and high volume lumbar
punctures are often required, which may increase sensitivity up to
90%, but are associated with patient discomfort, treatment delays,
and complications.
About Biocept
Biocept, Inc. is a molecular diagnostics company with
commercialized assays for lung, breast, gastric, colorectal and
prostate cancers, and melanoma. The Company uses its proprietary
liquid biopsy technology to provide physicians with clinically
actionable information for treating and monitoring patients
diagnosed with cancer. The Company's patented Target Selector™
liquid biopsy technology platform captures and analyzes
tumor-associated molecular markers in both circulating tumor cells
(CTCs) and in circulating tumor DNA (ctDNA). With thousands of
tests performed, the platform has demonstrated the ability to
identify cancer mutations and alterations to inform physicians
about a patient's disease and therapeutic options. For additional
information, please visit www.biocept.com.
Forward-Looking Statements Disclaimer Statement
This 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
have been 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 release are not strictly historical, including
without limitation statements as to our ability to improve the
outcome of cancer patients, the clinical utility of our liquid
biopsy technology to improve the diagnosis and treatment of LM, and
the future market opportunities and commercial expansion of our
liquid biopsy technology, 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 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, which
can be accessed over the Internet at the SEC's website located at
www.sec.gov.
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SOURCE Biocept, Inc.