Target Selector™ EGFR assays offer ultra-high
sensitivity and require less tumor sample than most commercial
assays
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, will collaborate with
Protean BioDiagnostics Inc. to research the ability of Biocept’s
Target Selector™ molecular assay to determine EGFR status in
non-small cell lung cancer (NSCLC) patients. The research will be
conducted in an independent pathology laboratory setting.
Protean BioDiagnostics also expects to validate the analytical
performance of a laboratory developed test (LDT) based on Biocept’s
EGFR assay test kit in accordance with the requirements of the
College of American Pathologists (CAP) validation process.
Biocept’s novel molecular assay kit, available for
research-use-only and with CE-IVD mark, enables molecular
laboratories around the world to utilize its Target Selector
platform to analyze both formalin-fixed paraffin-embedded (FFPE)
tissue samples and circulating tumor DNA (ctDNA) from biological
fluids. Target Selector leverages patented Switch-Blocker
technology to enrich specimens for mutations of interest and block
DNA amplification from normal cells, requiring less tumor sample
and resulting in higher assay sensitivity than most commercial
assays. Biocept’s molecular assays have been validated for the
detection of frequent oncogenic mutations EGFR, KRAS and BRAF,
which are among the most frequently evaluated biomarkers for lung
cancer and melanoma.
“We are pleased to collaborate with Biocept to demonstrate the
potential of its assay in determining EGFR status,” said Anthony M.
Magliocco, MD, President and CEO of Protean BioDiagnostics.
“Obtaining adequate tissue sample for genomic profiling continues
to be a challenge in first-line therapy selection for patients with
NSCLC. Target Selector EGFR assays require 50% less tumor input
sample than most commercial assays, making it a potentially
powerful tool in helping qualify more patients for targeted
tyrosine kinase inhibitor, or TKI, therapy. This potential
advantage is coupled with previous studies demonstrating Target
Selector assays’ best-in-class low-end limit of detection of
mutations in both FFPE and liquid biopsy samples.”
“Protean BioDiagnostics is the ideal partner for this
collaboration, as we share a joint commitment to advancing the best
possible care for patients with cancer,” said Michael Nall, Biocept
President and CEO. “Protean has extensive experience working with
some of the world’s leading biotechnology companies. Together, our
goal is to demonstrate how Target Selector assays can help
physicians create more personalized, responsive treatment plans for
their patients.”
About Target Selector™ Molecular Assay Kits Target
Selector molecular assay kits are marketed for research-use-only
(RUO) in the U.S. and CE-IVD in the European Union and other CE
Mark geographies, offering industry-leading sensitivity for the
detection of mutations/variants of interest in both FFPE and ctDNA.
Target Selector assays with Switch-Blocker technology can also
provide results with smaller DNA inputs (minimum 4.6 ng) than most
tissue-based assays, allowing laboratories to get results even with
small amounts of tissue. These capabilities should allow
laboratories to eliminate macro-dissection of tumor blocks,
potentially resulting in major workflow improvements and cost
savings.
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 (RUO and CE-IVD) 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.
Target Selector molecular assay kits (RUO and CE-IVD) are
currently available for EGFR and BRAF mutations. Additional test
kits for other oncogene mutations are planned for launch in the
future. For more information on Biocept's Target Selector molecular
assay kits, contact Biocept Customer Service at (888) 332-7729 or
customerservice@biocept.com.
About Protean BioDiagnostics Protean BioDiagnostics Inc
is a disruptive biotechnology company developing and
commercializing novel cancer diagnostics supporting precision
oncology. Protean has created Oncology MAPS™ - a unique and
innovative, fully integrated diagnostic system for oncologists.
This easy-to-deploy system enables rapid access to precision
diagnostics for underserved community-based cancer doctors and
their patients wherever they practice. Oncology MAPS™ includes
comprehensive support and access to the latest genetic, molecular
and cancer blood monitoring tests as well as educational and
telemedicine support.
Protean is transforming cancer practice using a big data
approach which integrates digital pathology, multi-omics, and
artificial intelligence. Protean also provides support for contract
research, clinical trials, and novel biomarker development using
its CAP-accredited, CLIA-certified laboratories and through its
extensive client networks.
Companion diagnostics can be quickly evaluated and deployed
leveraging Protean’s extensive laboratory capabilities, expertise,
and extensive global research networks.
About Biocept Biocept, Inc. is a molecular diagnostics
company developing and commercializing assays for lung, breast,
gastric, colorectal and prostate cancers, and melanoma. The Company
uses its proprietary technology to provide physicians with
clinically actionable information for treating and monitoring
patients diagnosed with cancer. The Company’s patented Target
Selector™ molecular diagnostic 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.
Additionally, Biocept is offering nationwide COVID-19 polymerase
chain reaction (PCR) testing to support public health efforts
during this unprecedented pandemic. For additional information,
please visit www.biocept.com. Follow Biocept on Facebook, LinkedIn
and Twitter.
Forward-Looking Statements 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 regarding the ability of our assays to improve the
outcomes of patients diagnosed with cancer, the ability of our
Target Selector molecular assay to determine EGFR status in NSCLC
patients, the potential validation of the analytical performance of
an LDT based on our EGFR assay test kit, the potential of our assay
to determine EGFR status, the ability of our Target Selector assays
to help physicians create more personalized, responsive treatment
plans for their patients, the ability of our Target Selector assay
to allow laboratories to eliminate macro-dissection of tumor blocks
and improve workflow and cost savings, our future launch of test
kits for additional oncogene mutations and the speed with which
companion diagnostics can be evaluated and deployed, 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 risks and uncertainties, including the risk that our
products and services may not perform as expected and the risk that
we will not be able to enter into additional services agreements.
These and other risks are described in greater detail under the
"Risk Factors" heading of our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020. 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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version on businesswire.com: https://www.businesswire.com/news/home/20210223005381/en/
Media contact—Biocept Andrea Sampson, Sampson PR Group
asampson@sampsonprgroup.com 562-304-0301 Investor
Contact—Biocept Jody Cain, LHA Investor Relations
Jcain@lhai.com 310-691-7100 Media Contact—Protean
BioDiagnostics Paul Moon Paul.moon@proteanbiodx.com
403-390-1676
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