SAN DIEGO, Nov. 7, 2019 /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 CE (Conformité Européene) IVD
Marks and availability of its CEE-Sure® Blood Collection Tube and
CEE-Sure® Sample Collection Shipping Kit in Europe. The CE Marks confirm that the
Company's CEE-Sure® products, designed to collect and
transport blood and other liquid biopsy specimens, meet the
requirements of the European In-Vitro Diagnostic Devices Directive
(98/79/EC), which now allows Biocept to commercialize its tubes and
collection/shipping kits throughout the European Union and other CE
Mark geographies.
"We are excited to announce this milestone, that our proprietary
specimen collection tubes and shipping kits are now commercially
available in Europe, consistent
with our quest to brand Biocept globally as a leading technology
provider in the liquid biopsy segment," stated Michael Nall, Biocept's President and CEO. "Our
internally-developed and patented tube technology offers the
ability to preserve and ship specimens containing CTCs, ctDNA, and
ctRNA for use in oncology and prenatal diagnostics, as well as
other molecular testing, throughout the world without refrigeration
or special handling. We believe that these advantages will enable
more patients to benefit from the use of liquid biopsy."
About Biocept's CEE-Sure® Blood Collection
Tube
The CEE-Sure® Blood Collection Tube allows for the intact
transport of liquid biopsy samples at room temperature from the
clinic to central laboratories conducting molecular and cellular
analyses. A unique feature is the ability to preserve CTCs, ctDNA
or ctRNA collected from the patient in the same tube. The CEE-Sure®
technology has a unique patented media that inhibits cell clumping,
thus preventing clogging of microfluidics devices, which is a
common problem with CTC analysis. It also can preserve
high-quality circulating ctDNA or ctRNA for advanced molecular
testing platforms like next generation sequencing (NGS), and
applications such as non-invasive prenatal testing and detection of
gene mutations in cancer. The CEE-Sure® Blood Collection
Tube can be used to collect and transport many specimen types
including blood, cerebrospinal fluid, sputum, and fluid obtained
from pleural effusion. Use of these collection tubes does not
require pre-shipment specimen processing, refrigeration during
shipping, or centrifugation upon receipt, which can be barriers to
the adoption of liquid biopsy. Study data demonstrating the ability
to successfully collect and preserve patient blood samples for use
with single gene tests and a broad liquid biopsy panel were
presented in a poster at the 2017 American Association for Cancer
Research (AACR) Annual Meeting.
About Biocept's CEE-Sure® Sample Collection and Shipping
Kits
Biocept's CEE-Sure® Sample Collection and Shipping Kit contains
Biocept's CEE-Sure® Blood Collection Tubes as well as components
and instructions for collecting and shipping the blood samples.
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
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 CTCs and in plasma (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 enabling more patients to
benefit from the use of liquid biopsy and the potential
clinical utility of our proprietary technology platform, 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.
Contact:
LHA Investor Relations
Jody Cain
Jcain@lhai.com
310-691-7100
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SOURCE Biocept, Inc.