Study Shows Biocept’s Target Selector™ Detects Mutations in “Quantity Not Sufficient” Specimens in Non-Small Cell Lun...
February 16 2021 - 7:00AM
Business Wire
Data to be presented at Molecular Med Tri-Con
Virtual Conference
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, will present data showing
that its Target Selector™ molecular assay kit detects mutations in
up to 50% of tissue biopsy specimens, from patients diagnosed with
non-small cell lung cancer, that were deemed quantity not
sufficient (QNS). The study will be presented at the Molecular Med
Tri-Con Virtual Conference, Feb. 16-18, 2021.
Molecular testing of biopsy specimens is critical to identify
genetic mutations and guide potential treatment with targeted
therapies. However, in up to 40% of cases, specimens lack
sufficient tissue to perform testing1 and are deemed insufficient.
The presence of non-tumor cells can also be an obstacle in
detecting specific mutations. As a result, QNS specimens are a
significant issue in molecular diagnostic testing and a key
challenge faced by oncologists and pathologists in managing cancer
patients.
The pilot study utilized Biocept’s Target Selector molecular
assay with Switch-Blocker technology, which offers ultra-high
sensitivity and requires less tumor sample than most commercial
assays. The assay was used to evaluate the presence of several key
EGFR and KRAS mutations in formalin-fixed paraformaldehyde embedded
(FFPE) tissue slides, supplied by NeoGenomics Laboratories, Inc.
that were deemed QNS for next generation sequencing (NGS) analysis.
Results showed that EGFR mutations were detected in 50% (3/6) of
patient samples, and KRAS mutations in 17% (1/6) of samples.
“We’re looking for rare mutations from a very small tissue
sample in a large background of non-tumor cells to help us guide
treatment decisions for patients,” said Michael C. Dugan, M.D.,
Senior Vice President, Chief Medical Officer and Medical Director
of Biocept. “This collaboration with NeoGenomics confirms that our
Target Selector assay used with FFPE samples has the potential to
provide molecular results when other common platforms can’t,
offering actionable information for physicians to help identify
potential targeted therapy options.”
Biocept’s Target Selector assay kits, available for
research-use-only and CE-IVD, detect mutations in DNA derived from
FFPE or blood plasma to give insight into a patient’s cancer
characteristics and provide tumor biomarker status. Target Selector
utilizes patented Switch-Blocker technology to enrich specimens for
mutations of interest and block DNA amplification from normal
cells, resulting in ultra-high assay sensitivity and specificity
compared to other methods currently used in laboratories. The kits
allow molecular laboratories around the world to use Target
Selector assays to detect key oncogene mutations through the
analysis of both FFPE tissue from surgical biopsies and ctDNA from
blood-based liquid biopsies. Biocept also offers Target Selector
ctDNA-based tests in its CLIA-certified, CAP-accredited
laboratory.
Biocept’s virtual exhibit at the Tri-Con conference will offer
information about the company’s molecular assay technologies that
assist clinicians and researchers in understanding the genomic
basis of cancer. Also at the conference, Dr. Dugan will participate
in a roundtable discussion on understanding the value and
analytical requirements of circulating tumor cell (CTC) analysis as
part of a comprehensive liquid biopsy analysis. The panel, titled
“Introducing CTC Assays to Service Laboratories,” will be held
Wednesday, Feb. 17, at 12:55 p.m. ET. More information about the
roundtable can be found here.
The poster, titled “Detection of EGFR Mutations in Quantity
Insufficient Tissue Slides by High Sensitivity Assay Target
Selector in Patients with Non-Small Cell Lung Cancer,” can be
accessed here.
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 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. 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, 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. These and other
risks are described in greater detail in our filings with the
Securities and Exchange Commission (SEC), including 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.
1. Harada S, Agosto-Arroyo E, Levesque JA, et al. Poor cell
block adequacy rate for molecular testing improved with the
addition of Diff-Quik-stained smears: Need for better cell block
processing. Cancer Cytopathol. 2015; 123(8):480-7.
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Investor Contact: Jody Cain, LHA Investor Relations
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