SAN DIEGO, Nov. 28, 2017 /PRNewswire/ -- Biocept, Inc.
(NASDAQ: BIOC), a leading commercial provider of liquid biopsy
tests designed to provide physicians with clinically actionable
information to improve the outcomes of patients diagnosed with
cancer, announces entering into a clinical study agreement with the
University of California San Diego
(UCSD) Medical Center. Led by recognized immune-oncology and
precision medicine specialist Sandip
Patel, M.D., Assistant Professor at UCSD School of Medicine,
the 100-patient study is designed to clinically validate Biocept's
Target Selectorâ„¢ PD-L1 assay for patients diagnosed with non-small
cell lung cancer (NSCLC). Importantly, Biocept's assay for PD-L1
will be evaluated using the two common antibody clones for PD-L1
detection, 28-8 and 22C3, which have the potential to offer high
biomarker detection rates using liquid biopsy. The study's primary
endpoint is concordance between tissue biopsy and liquid biopsy for
the detection of PD-L1 protein expression. Correlation between
treatment response and PD-L1 status as detected using liquid biopsy
will be examined as a secondary endpoint in the study.
"Liquid biopsies have revolutionized oncology and precision
medicine with the ability to obtain important biomarker information
to identify patients for targeted therapy," said Dr. Patel.
"In particular, identification of key driver mutations such as
EGFR, ALK, and ROS1, among others, are crucial in advanced NSCLC,
and liquid biopsy plays an important role in assessing for these
targetable pathways. Equally important is PD-L1 staining in
front-line NSCLC to assess for a 50% tumor-proportion score, which
is key for the utilization of immunotherapy. To date,
primarily tissue testing has been available to assess PD-L1 status,
and this study attempts to broaden the use of liquid biopsies to
encompass PD-L1 scoring, which is crucial in determining whether
immunotherapy may be appropriate for a patient in a given disease
setting."
"Immunotherapy has become an important treatment strategy for
patients diagnosed with cancer and we believe that our unique
liquid biopsy assay for PD-L1 offers a solution for rapid and
non-invasive detection of this critical biomarker," said Biocept's
President and Chief Executive Officer Michael Nall. "We continue to evaluate our
Target Selectorâ„¢ platform in clinical studies in which the
identification of clinically actionable biomarkers, like PD-L1
protein expression, can help guide treatment decisions resulting in
improved patient outcomes. We are excited to initiate this study
with Dr. Patel and the UCSD Medical Center."
About PD-L1 Biomarker Expression Using Liquid
Biopsy
PD-L1 immunohistochemistry (IHC) on tumor tissue is
an important predictive biomarker for anti-PD-1/anti-PD-L1 cancer
immunotherapy. PD-L1 IHC is a companion diagnostic for the
utilization of anti-PD-1 directed therapies in non-small cell lung
cancer (NSCLC) and bladder cancer, and can predict response to
immune checkpoint blockade. However, tissue biopsy is not always
available or may be insufficient to accurately test for PD-L1
expression and biopsy samples may not reflect the actual PD-L1
expression of the tumor due to tumor heterogeneity. Given this
heterogeneity and the risks inherent with tissue biopsy, the
ability to detect tumor PD-L1 status with a simple blood draw would
be a major advance in this field. In addition to minimizing patient
risk from a tissue biopsy, a circulating biomarker assay can avoid
biopsy selection bias and provide a snapshot of the dynamic tumor
landscape. Biocept has developed proprietary, minimally-invasive
blood-based assays for the analysis of biomarkers on tumor-derived
cells and cell-free DNA with the purpose of detecting predictive
genomic and protein expression markers such as PD-L1 to aid in
therapeutic selection.
About Biocept
Biocept, Inc. is a molecular diagnostics
company with commercialized assays for lung, breast, gastric,
colorectal and prostate cancers, and melanoma. The Company
leverages its proprietary liquid biopsy technology to provide
physicians with clinically actionable information for treating and
monitoring patients diagnosed with cancer. Biocept's patented
Target Selectorâ„¢ 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
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 our ability to
improve the outcomes of patients diagnosed with cancer, the success
of the UC San Diego Medical Center study and its ability to meet
its objectives, our ability to further validate our liquid biopsy
technology, and our ability to increase the clinical adoption of
our testing services, 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 www.sec.gov
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SOURCE Biocept, Inc.