SAN DIEGO, Dec. 7, 2016 /PRNewswire/ -- Biocept, Inc.
(NASDAQ: BIOC), a leading commercial provider of clinically
actionable liquid biopsy tests to improve the management of cancer
patients, announces the analytical validation study results for its
blood-based PD-L1 assay, which demonstrate the highly sensitive,
specific, and reproducible performance of this immunotherapy
biomarker test. The study results, "Validation of PD-L1 Expression
on Circulating Tumor Cells in Lung Cancer," were presented today in
a poster session at the IASLC World Conference on Lung Cancer in
Vienna, Austria, in collaboration
with David Rimm, M.D., Ph.D.,
Professor of Pathology and Medical Oncology at the Yale University School of Medicine and renowned
PD-L1 diagnostics thought leader.
In the study, introduced cell lines derived from multiple
cancers were tested with Biocept's PD-L1 assay using its
proprietary Target Selector™ platform to capture and interrogate
tumor cells for PD-L1 expression. Results yielded 100%
concordance between PD-L1 expression of the tumor cells and their
original PD-L1 status, whether positive or negative. Further
clinical testing demonstrated the ability of Biocept's PD-L1 assay
to successfully determine PD-L1 status on the circulating tumor
cells (CTCs) of clinical samples.
"Assessing PD-L1 status of a cancer patient has become
increasingly important, as immuno-oncology treatments such as
Merck's Keytruda® and Bristol-Myers Squibb's Opdivo® target the
immune checkpoint pathway and expression of this biomarker," stated
Dr. Rimm. "These pilot results demonstrate the ability of Biocept's
blood-based circulating tumor cell assay to identify the presence
of PD-L1 on circulating tumor cells, which can have important
implications in cases when a tissue biopsy is insufficient or not
practical."
The human immune system can recognize and eliminate tumor cells
through immunosurveillance, however, certain cancer cell types
suppress immune function by expressing programmed cell death ligand
1 (PD-L1), which binds to its receptor, PD-1, on T cells to prevent
their activation. As a result, high levels of PD-L1 expression are
associated with poor patient prognosis. Immunotherapies such as
Keytruda ® and Opdivo® inhibit the PD-1/PD-L1 pathway and allow the
body's natural defenses to combat the tumor. To determine which
patients are suitable candidates for receiving immunotherapy,
levels of PD-L1 expression are traditionally determined from tumor
biopsies. However, the amount of tumor tissue or the variability in
tumor tissue composition (tumor heterogeneity) can confound these
results, creating the need for a non-invasive methodology for the
identification and subsequent monitoring of tumor-associated PD-L1
expression.
"These data support the high sensitivity of our Target Selector™
platforms and our focus on providing clinically actionable
information to oncologists and their patients based on a simple
blood test," stated Lyle Arnold,
Ph.D., Biocept's Chief Scientific Officer. "Our proprietary liquid
biopsy technology offers the unique ability to analyze oncogene
mutations, amplifications, fusions and tumor-associated proteins
such as PD-L1, enabling an analysis of cancer-driving molecular
alterations to improve patient care."
"The presentation of these study results at a major cancer
conference significantly increases our visibility with lung cancer
specialists and further supports the use of our high performance
liquid biopsy platform," said Michael W.
Nall, President and Chief Executive Officer of
Biocept. "We remain focused on providing the most clinically
relevant menu of cancer biomarkers in a liquid biopsy platform to
provide oncologists with the actionable information they need to
improve the care of their patients."
About the IASLC World Conference on Lung Cancer
The IASLC World Conference on Lung Cancer is the world's largest
meeting dedicated to lung cancer and other thoracic malignancies.
More than 7,000 delegates come from more than 100 countries
to discuss the latest developments in thoracic malignancy research.
Attendees include surgeons, medical oncologists, radiation
oncologists, pulmonologists, radiologists, pathologists,
epidemiologists, research scientists, nurses and patients.
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
management, diagnosis and treatment of cancer, the ability of our
tests to provide clinically actionable information to oncologist
and their patients, and our ability to expand the adoption of our
tests, 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.