SAN DIEGO, June 18, 2019 /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 commercial launch of its Target Selector™ NGS
Breast Panel, the Company's multi-gene liquid biopsy panel
specifically developed for breast cancer. The panel runs on Thermo
Fisher Scientific's Ion Torrent™ next generation sequencing (NGS)
platform and will be marketed to physicians and researchers for the
detection and monitoring of actionable genomic biomarkers
associated with breast cancer.
The Target Selector™ NGS Breast Panel combines Biocept's
laboratory and commercial infrastructure, as well as the Company's
expertise in blood sample preservation and DNA/RNA isolation, with
Thermo Fisher's industry-leading NGS
panel and informatics technology, branded as Oncomine™.
Biocept believes that this offering also has potential to
further enrich the content supporting Biocept's collaboration with
artificial intelligence solutions provider Prognos Health, Inc.
Breast cancer is the most commonly diagnosed cancer in
women and the second leading cause of cancer death among
women1. It is estimated that each year over
250,000 women in the United States
will be diagnosed and more than 40,000 will die from the
disease1. Molecular profiling is used to
determine the status of actionable biomarkers such as ER, PR and
HER2 to guide clinicians in their treatment selection for women
with breast cancer. These key targets help doctors understand
which therapies may have the best chance of success and can also be
used to help breast cancer patients qualify for clinical
trials.
Published guidelines from the American Society of Clinical
Oncology (ASCO) and the College of American Pathologists (CAP)
outline standards for determining biomarker status in patients
diagnosed with breast cancer2-5. Excision
biopsies to retest initial negative results are included in
clinical practice recommendations.5 These
guidelines help to ensure that patients with breast cancer have an
opportunity to qualify for potentially effective targeted
therapies. However, for many breast cancer patients a metastatic
biopsy may be difficult or impossible to obtain due to the physical
location of a distal lesion, such as the bone, lung, brain or other
hard to biopsy site. Biocept's innovative liquid biopsy solutions
allow clinicians to evaluate or monitor biomarker status in
patients with metastatic breast cancer utilizing its 12-gene Target
Selector™ NGS Breast Panel, or its Target Selector™ single
biomarker tests based on the Company's proprietary circulating
tumor DNA (ctDNA) or recently expanded circulating tumor cell (CTC)
detection platforms.
"We are extremely pleased to launch our second multi-gene liquid
biopsy panel, this one tailored to breast cancer, which expands our
Target Selector family of offerings to physicians and researchers
in both academic centers and the pharmaceutical industry," said
Michael Nall, Biocept's President
and Chief Executive Officer. "This additional offering
provides a unique liquid biopsy platform interrogating both CTCs
and ctDNA in patients with breast cancer. We believe this dual
approach enhances the identification of actionable genomic
alterations to provide personalized treatment options.
"The multi-gene panel has undergone robust and extensive
analytical and clinical validation to identify all main classes of
genomic aberrations encountered in breast cancer, with an overall
clinical accuracy of 99.8%, specificity of greater than 99% and
sensitivity of greater than 90%," he added. "Biocept remains
the only commercial liquid biopsy company that can offer customers
the flexibility to order either customized single biomarker assays
or a larger NGS-based liquid biopsy test panel for use when more
comprehensive testing is desired."
About Biocept's Target Selector™ NGS Breast
Panel
Biocept's multi-gene tumor-specific NGS-based liquid biopsy
panels allow physicians and researchers to use a simple blood
sample to analyze actionable biomarkers associated with specific
solid tumor types. The biomarkers included in the Target Selector™
NGS Breast Panel are those physicians frequently rely upon when
making treatment decisions for their patients diagnosed with breast
cancer and includes reporting powered by the Oncomine™ Knowledge
Reporter. For more information about the Target Selector™ NGS Lung
Panel, please contact Biocept Customer Services at
888-332-7729.
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 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 CTCs and 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 potential clinical
utility of our proprietary technology platform, the commercial
success of our Target Selector™ NGS Breast Panel and the success of
our collaboration with Prognos Health, Inc., 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 http://www.sec.gov/.
References:
[1] National Breast Cancer Foundation;
https://www.nationalbreastcancer.org/breast-cancer-facts.
[2] Andre, F., Ismaila, N., Henry, N. L., Somerfield, M. R.,
Bast, R. C., Barlow, W., Collyar, D. E., Hammond, M. E., Kuderer,
N. M., Liu, M. C., Poznak, C. V., Wolff, A. C., and Stearns, V.
(2019) Use of Biomarkers to Guide Decisions on Adjuvant Systemic
Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO
Clinical Practice Guideline Update—Integration of Results From
TAILORx, Journal of Clinical Oncology 37,
JCO.19.00945.
[3] Burstein, H. J., Lacchetti, C., Anderson, H., Buchholz, T.
A., Davidson, N. E., Gelmon, K. A., Giordano, S. H., Hudis, C. A.,
Solky, A. J., Stearns, V., Winer, E. P., and Griggs, J. J. (2019)
Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive
Breast Cancer: ASCO Clinical Practice Guideline Focused Update,
Journal of clinical oncology : official journal of the American
Society of Clinical Oncology 37, 423-438.
[4] Giordano, S. H., Temin, S., Chandarlapaty, S., Crews, J. R.,
Esteva, F. J., Kirshner, J. J., Krop, I. E., Levinson, J., Lin, N.
U., Modi, S., Patt, D. A., Perlmutter, J., Ramakrishna, N., Winer,
E. P., and Davidson, N. E. (2018) Systemic Therapy for Patients
With Advanced Human Epidermal Growth Factor Receptor 2-Positive
Breast Cancer: ASCO Clinical Practice Guideline Update, Journal
of clinical oncology : official journal of the American Society of
Clinical Oncology 36, 2736-2740.
[5] Wolff, A. C., Hammond, M. E. H., Allison, K. H., Harvey, B.
E., Mangu, P. B., Bartlett, J. M. S., Bilous, M., Ellis, I. O.,
Fitzgibbons, P., Hanna, W., Jenkins, R. B., Press, M. F., Spears,
P. A., Vance, G. H., Viale, G., McShane, L. M., and Dowsett, M.
(2018) Human Epidermal Growth Factor Receptor 2 Testing in Breast
Cancer: American Society of Clinical Oncology/College of American
Pathologists Clinical Practice Guideline Focused Update,
Archives of pathology & laboratory medicine 142,
1364-1382.
Contact:
LHA Investor Relations
Jody Cain
Jcain@lhai.com
310-691-7100
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SOURCE Biocept, Inc.