Biocept’s CNSide Cerebrospinal Fluid Assay Identifies Actionable HER2 Mutations in Patients with Breast Cancer that has Metastasized to the Brain
09 Dezembro 2021 - 10:17AM
Business Wire
Spotlight Presentation at SABCS showed that in
38% of patients the HER2 status of the metastatic cancer differed
from the primary tumor, offering new information to aid treatment
decisions
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, presented a study
demonstrating the ability of its CNSide™ assay to identify HER2 and
other actionable tumor alterations in the cerebrospinal fluid of
patients with breast cancer and leptomeningeal disease (LMD). The
poster was chosen for a Spotlight Presentation at the San Antonio
Breast Cancer Symposium on Dec. 8, 2021.
LMD is a devastating complication in which cancer spreads to the
membrane surrounding the brain and spinal cord. The current
standard of care for diagnosing LMD is through clinical evaluation,
imaging and cytology, which have limited sensitivity and are unable
to identify important tumor biomarkers such as HER2. HER2-targeted
treatment for patients with breast cancer and LMD may provide
substantial survival advantages over the expected median survival
of less than three months.
In this analysis, cerebrospinal fluid (CSF) of 63 patients with
stage IV breast cancer and LMD was collected, and CSF tumor cells
were captured and characterized using CNSide. HER2 amplification
was detected in 56% of all patients. HER2 status differed between
the primary tumor and LMD in 38% of cases, with more than 80% of
those patients exhibiting a switch from a HER2-negative primary
tumor to HER2-positive LMD.
“Knowing if a patient’s tumor is HER2 positive or negative, and
especially whether HER2 status has changed from primary tumor to
LMD, allows us to more precisely treat those patients and achieve a
better response,” said Amir Azadi, M.D., a neuro-oncologist at
Banner MD Anderson, who participated in a key opinion leader
webcast event earlier this year discussing the advantages of CNSide
in detecting central nervous system metastases. “Patients with
brain metastases and leptomeningeal disease have a very poor
prognosis. CNSide provides new information to help guide treatment
decisions that may extend life expectancy and improve quality of
life for these patients.”
“Our CNSide assay can be used both to confirm the presence of
tumors and to identify important biomarkers in LMD such as HER2,”
said Michael Dugan, M.D., Chief Medical Officer and Medical
Director of Biocept. “Finding HER2 amplification in breast cancer
tumor cells in the CSF is critical because anti-HER2 targeted
therapy provides one of the best options for physicians treating
patients with breast cancer who have developed the life-threatening
complications of LMD.”
The CNSide CSF assay is designed to help physicians better
detect and manage treatment of metastatic cancers involving the
central nervous system. It provides a timely and accurate method to
help diagnose these tumors, identify actionable biomarkers and
assess response to therapy, with the goal of improving patient
survival and quality of life. The assay is based on Biocept’s
proprietary quantitative tumor cell capture and detection method,
paired with assays to identify actionable molecular treatment
targets. CNSide has the ability to answer key questions that may
help inform treatment decisions: Is there involvement by tumor? Is
there a target for treatment? Is there a trend with respect to
treatment response?
The poster, titled, “Characterization of HER2 Amplification in
the Cerebrospinal Fluid of Patients with Leptomeningeal Disease in
Stage IV Patients with Breast Cancer,” can be accessed here.
About Biocept
Biocept, Inc. develops and commercializes molecular diagnostic
assays that provide physicians with clinically actionable
information to aid in the diagnosis, treatment and monitoring of
patients with cancer. In addition to its broad portfolio of
blood-based liquid biopsy tests, the company has developed the
CNSide™ cerebrospinal fluid assay, designed to diagnose cancer that
has metastasized to the central nervous system. Biocept also is
leveraging its molecular diagnostic capabilities to offer
nationwide RT-PCR-based COVID-19 testing and services to support
public health efforts during this unprecedented pandemic. For more
information, visit www.biocept.com. Follow Biocept on Facebook,
LinkedIn and Twitter.
Forward-Looking Statements Disclaimer
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 Biocept believes that the
expectations reflected in the forward-looking statements and the
assumptions upon which they are based are reasonable, Biocept 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," "could,"
"expect," or "believe" 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 capabilities
and potential benefits of Biocept’s CNSide assay and the ability of
Biocept’s assays to provide physicians with clinically actional
information, 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 Biocept’s products and services may not
perform as expected. These and other risks are described in greater
detail under the "Risk Factors" heading of Biocept’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2021, filed
with the Securities and Exchange Commission (SEC) on November 15,
2021. The effects of such risks and uncertainties could cause
Biocept’s actual results to differ materially from the
forward-looking statements contained in this release. Biocept does
not plan to update any such forward-looking statements and
expressly disclaims any duty to update the information contained in
this press release except as required by law. Readers are advised
to review Biocept’s 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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Media Contact: Andrea Sampson, Sampson PR Group
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Investor Contact: Jody Cain, LHA Investor Relations
Jcain@lhai.com, 310-691-7100
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