Medicare Issues Local Coverage Determination for Biocept’s Target Selector™ Breast Cancer Assay to Detect the HER2 Biomar...
July 21 2021 - 8:17AM
Business Wire
Reimbursement decision expands access to
testing that provides critical information used to guide targeted
treatment options for patients with breast cancer
Company provides updates on other initiatives
including CNSide™, its proprietary test for neuro-oncology, and
COVID-19 testing volume, which has now reached over 450,000
samples
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays and services, has received a positive final Local
Coverage Determination (LCD) that expands Medicare coverage for use
of its Target Selector assay to identify the HER2 biomarker from
circulating tumor cells (CTCs). This coverage determination from
the Centers for Medicare & Medicaid Services (CMS) Molecular
Diagnostics Program (MolDx) was effective July 4, 2021.
About 20% of breast cancers are HER2-positive, with metastatic
cancers more likely to be HER2-positive and approximately 20% of
HER2-positive patients experiencing recurrence each year. Given the
efficacy of various anti-HER2 therapies, testing for HER2 is one of
the most important sources of information used by oncologists in
making treatment decisions for patients with breast cancer. As a
result, guidelines for breast cancer recommend that all patients
with new primary or newly metastatic breast cancer be tested for
HER2. Traditionally, testing has been performed using tissue.
However, adequate tissue from the original biopsy may not be
available, and additional invasive biopsy procedures are often
impractical and associated with complications.
“Target Selector is a highly sensitive assay for identifying
HER2 status that is less invasive, more time-efficient and more
cost-effective than tissue biopsy,” said Michael Dugan, M.D.,
Biocept’s Senior Vice President, Chief Medical Officer and Medical
Director. “Metastatic tumors often show genetic changes that are
associated with disease progression and frequently have features of
HER2 gene amplification that are not present in the primary tumor.
Target Selector’s ability to both detect and characterize the tumor
cells provides critical information to help identify patients who
may benefit from advanced targeted therapies, with the potential to
significantly improve patient outcomes.”
The MolDx program was developed by CMS to identify and establish
coverage and reimbursement for molecular diagnostic tests. To
receive a favorable MolDx coverage determination, assays must
demonstrate clinical utility, fulfill the CMS reasonable and
necessary criteria, and meet analytical and clinical validity
standards. The LCD, which includes other cancer biomarkers in
addition to HER2, is posted on the CMS website and can be accessed
here.
“This coverage determination for our Target Selector assay is
important for physicians and patients, as it expands access to a
test that can provide the opportunity to find answers that may
otherwise not be available from traditional approaches,” said
Michael Nall, President and CEO of Biocept. “We are very pleased
with this achievement and are excited to be making significant
progress on a number of fronts that address critical needs in
oncology and support public health efforts.”
Biocept’s combined cell-based and cell-free liquid biopsy tests
assess actionable cancer biomarkers from a patient’s blood and,
uniquely, from cerebrospinal fluid (CSF) as well. Following the
full commercial launch of its CSF assay, CNSide, Biocept submitted
an initial application for Breakthrough Device Designation to the
U.S. Food and Drug Administration (FDA). While the initial
submission was recently denied, the company continues to pursue
Breakthrough Device Designation for CNSide and is gathering data
based on the feedback provided by the FDA to further support its
submission. The test is currently marketed as a Lab Developed Test
(LDT) in Biocept’s CLIA certified and CAP accredited lab. CNSide is
designed to improve the clinical management of patients with
suspected metastatic cancer involving the central nervous
system.
The company also continues to provide COVID-19 testing services
to help manage the impact of COVID-19 in long-term care facilities,
schools and other public facilities it serves. Biocept has received
more than 450,000 samples for SARS-CoV-2 testing since launching
this service in June 2020. The samples are processed using
Biocept’s RT-PCR-based technology at its CLIA-certified,
CAP-accredited, high-complexity molecular laboratory in San
Diego.
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 news 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
be correct. To the extent that statements in this news release are
not strictly historical, including, without limitation, statements
regarding the benefits that can be provided by our Target Selector
assay, our ability to receive FDA breakthrough device designation
for CNSide, and the ability of our assays to provide physicians
with clinically actionable information for treating and monitoring
patients diagnosed with a variety of cancers, 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 the
prevalence of HER2 in breast cancer patients will decline in the
future to a point where guidelines for breast cancer may no longer
recommend that all patients with new primary or newly metastatic
breast cancer be tested for HER2, which in turn would impact demand
for our Target Selector assay and could also impact its LCD, the
risk that we may not receive breakthrough device designation by the
FDA for CNSide, and even if we do, such designation may not lead to
a faster development, regulatory review or clearance process, and
it may not increase the likelihood that the assay will receive
marketing authorization from the FDA, and the risk that our
products and services may not perform as expected. 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
March 31, 2021, as filed with the Securities and Exchange
Commission (SEC) on May 12, 2021. The effects of such risks and
uncertainties could cause actual results to differ materially from
the forward-looking statements contained in this news 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 at http://www.sec.gov/.
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version on businesswire.com: https://www.businesswire.com/news/home/20210721005281/en/
Media Contact: Andrea Sampson, Sampson PR Group
asampson@sampsonprgroup.com, 562-304-0301
Investor Contact: Jody Cain, LHA Investor Relations
Jcain@lhai.com, 310-691-7100
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