SAN DIEGO, April 28, 2020 /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 the award of CE (Conformité Européene)-IVD Mark
for its Target Selector™ molecular assay EGFR Kit. The CE
Mark confirms that the Company's Target Selector™ kit products meet
the requirements of the European In-Vitro Diagnostic Devices
Directive (98/79/EC) and allows Biocept to commercialize its kits
throughout the European Union and other CE Mark geographies.
Biocept's Target Selector™ molecular assay kits detect key
oncogene mutations through the analysis of both Formalin-Fixed
Paraffin-Embedded (FFPE) tissue gained from surgical biopsies as
well as circulating tumor DNA (ctDNA) gained from blood-based
liquid biopsies. The EGFR pathway can include mutations that
are among the most frequently evaluated biomarkers for lung
cancer. The Biocept assay kit is designed to test for highly
informative EGFR mutations, including those necessary for treatment
decisions such as Del19, L858R and T790M. Biocept's future
plans include submission of additional biomarker Target Selector™
molecular assay kits for CE-IVD Mark.
Biocept's Target Selector™ ctDNA platform also utilizes the
Company's patented Switch-Blocker technology which enriches the
specimen for mutations of interest, resulting in ultra-high assay
sensitivity and specificity compared to other methods currently
used in other laboratories. Biocept's Target Selector™ assay
technology is patent protected in the
United States, seven countries in Europe and five international
territories.
"Obtaining the CE-IVD Mark expands the market opportunity for
our Target Selector™ molecular assay kits in the EU and other major
international markets where we are seeing an acceleration in
adoption of liquid biopsy-based testing," said Michael Nall, President and CEO of
Biocept. "We believe our Target Selector™ molecular assay
kits offer features that uniquely meet the needs of the EU and
other international markets through the highly sensitive detection
of key actional mutations and while being extremely cost
effective.
"Previously we announced CEE-IVD mark for our CEE-Sure™ ambient
temperature blood collection tube and ship kit. We are
excited to now offer laboratories in the EU and other international
markets a complete solution from sample acquisition to shipping and
on through molecular assay reporting for tissue or liquid
biopsy-based testing," he added.
About Biocept's Target Selector™ Molecular Assay Kits
Biocept's Target Selector™ molecular assay kits can enable
molecular laboratories around the world to detect key oncogene
mutations through the analysis of both Formalin-Fixed
Paraffin-Embedded (FFPE) tissue gained from surgical biopsies as
well as ctDNA gained from blood-based liquid biopsies.
Target Selector™ molecular assay kits utilize Biocept's
proprietary and patented Switch-Blocker technology to enable
industry-leading sensitivity for the detection of
mutations/variants of interest in ctDNA (one mutant copy in 10,000
wildtype DNA).
Due to its industry-leading sensitivity and the ability to block
DNA amplification from normal cells, we believe Target Selector™
should allow laboratories to eliminate macro-dissection of tumor
blocks, which can result in major workflow improvements and cost
savings in the pathology laboratory. Target Selector™ assays
can also provide results with small DNA inputs compared to most
tissue-based assays, thus allowing the laboratory to get results
even with small amounts of tissue.
The Target Selector™ assays can be used in combination with a
variety of low-cost analytical platforms including qPCR,
Sanger sequencing, microarrays,
and mass-spectrometry, in addition to next generation sequencing.
Target Selector™ kits offer high content per assay, which can
reduce costs by selectively amplifying multiple mutations/variants
in hot-spot regions of interest in a single reaction. All
Target Selector™ assays are quantitative.
For more information on Biocept's Target Selector™ liquid biopsy
kits, or to order Assay Kits, please contact Biocept Customer
Service at (888) 332-7729 or go to customerservice@biocept.com.
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 outcomes of patients
diagnosed with cancer, the market opportunity for our Target
Selector™ kits, the ability of our Target Selector™ kits to
uniquely meet the needs of the EU and other international markets,
the ability of our Target Selector™ kits to offer research
laboratories a number of efficiencies and cost savings, the ability
of our Target Selector™ kits to provide a result when other FFPE
assays may be unable to do so, and our ability to provide
physicians with clinically actionable information for treating and
monitoring patients diagnosed with cancer, 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.
Investor Contact:
LHA Investor
Relations
Jody Cain
Jcain@lhai.com
(310)
691-7100
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SOURCE Biocept, Inc.