Companies to take next step following
successful completion of feasibility studies
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostics, and
Biocept, Inc. (NASDAQ:BIOC), a molecular diagnostics company
commercializing and developing blood-based liquid biopsies to
improve the detection and treatment of cancer, announce the
successful completion of feasibility studies under a previously
announced collaboration to evaluate the use of Biocept's patented
microfluidic channel technology to extract circulating tumor cells
(CTCs) from blood and Rosetta Genomics' technical expertise and
proprietary qRT-PCR platform to characterize microRNAs isolated
from those CTCs.
In the next phase of the collaboration, Rosetta and Biocept will
test for markers currently offered by Rosetta, as well as pursue
new markers. This joint proof-of-concept study will initially seek
to determine whether lung cancer CTCs provide microRNA signatures
similar to those from tissue biopsy as previously demonstrated by
Rosetta through its Philadelphia-based, CLIA laboratory and that
are in clinical use today. Biocept’s technology allows for the
study of tumor cells from a simple blood draw starting with the
point-of-diagnosis and continuing throughout treatment. This
includes valuable insights when a patient's disease progresses
while on therapy due to emerging resistance, thus allowing the
clinician to plot the optimal next course of treatment. MicroRNA
analysis can provide unique insight into the biomarker profiles of
these cells. Combining current and new microRNA profiles through
the use of CTC capture could expand the role and utility of
microRNA signatures in various solid tumor diseases.
Feasibility studies were conducted using two lung cancer cell
lines: A549 and H727. The objectives were to determine whether
Biocept’s preservatives affect the microRNA profile of tested cell
lines and to determine the feasibility of profiling microRNAs using
Rosetta’s platform in samples containing a small number of
cells.
- In the first study, Biocept treated two
cell lines with two types of preservatives. The cells were then
sent to Rosetta for processing on its microarray platform to assess
the effects of these preservatives on miRNA expression. The results
indicated that the expression of Rosetta’s lung cancer microRNA
biomarker panel was unaffected.
- In the second study, Rosetta used its
qRT-PCR platform to profile samples containing a small number of
cancer cells (10-200 cells), using a select list of microRNAs based
on the first study. The results showed that all tested microRNAs
were detected in all samples tested.
“We are excited about advancing this collaboration to
proof-of-concept studies and to determine opportunities for next
steps in developing advanced diagnostics,” noted Kenneth A. Berlin,
President and Chief Executive Officer of Rosetta Genomics. “This
could include next-generation versions of certain tests that would
use CTCs from blood as ‘liquid biopsies’ in place of current
invasive approaches to provide clinicians with actionable
information to guide patient treatment protocols. With
proof-of-concept data, the joint platform could also be of value to
strategic partners seeking ways to use liquid biopsies along with
microRNA profiling and other downstream modalities, like
next-generation sequencing mutational profiles, to predict and
monitor responses to therapies.”
“Our liquid biopsy approach has advantages over invasive and
expensive surgical tissue biopsy procedures and we are encouraged
about the potential to expand its use by combining our CTC and
Rosetta’s microRNA technologies,” said Michael W. Nall, President
and Chief Executive Officer of Biocept. “Liquid biopsy is
particularly important in gaining biomarker information from
patients with lung cancer, where patients are often very sick,
making the collection of tissue biopsies impractical and often
impossible. Our blood-based biopsies also address the limitation of
tumor heterogeneity associated with tissue biopsies through the
ability to capture a more complete look at the tumor’s overall
makeup.”
About RosettaGX Cancer Testing Services
RosettaGX Cancer Tests are a series of microRNA-based and other
molecular diagnostic testing services offered by Rosetta Genomics.
RosettaGX Cancer Origin™ can accurately identify the primary tumor
type in primary and metastatic cancer including cancer of unknown
or uncertain primary (CUP). The mi-LUNG™ assay accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The mi-KIDNEY™ assay accurately classifies
the four most common kidney tumors: clear cell renal cell carcinoma
(RCC), papillary RCC, chromophobe RCC and oncocytoma. RosettaGX
Reveal™, is a first-of-its-kind microRNA-based assay for the
classification of indeterminate thyroid nodules. Rosetta’s assays
are designed to provide objective diagnostic data. In the U.S.
alone, Rosetta estimates that 150,000 patients a year may benefit
from the RosettaGX Cancer Origin test, 62,000 patients a year from
the mi-KIDNEY assay, 222,000 patients a year from the mi-LUNG assay
and 150,000 patients a year from RosettaGX Reveal™ for
indeterminate thyroid FNAs. Rosetta’s assays are offered directly
by Rosetta in the U.S., and through distributors around the world.
With the acquisition of PersonalizeDx in April 2015, Rosetta now
offers a broader menu of molecular and other assays for bladder,
lung, prostate and breast cancer patients. For more information,
please visit www.rosettagx.com. Parties interested in ordering any
of these tests can contact Rosetta at (215) 382-9000.
About Rosetta Genomics
Rosetta develops and commercializes a full range of
microRNA-based and other molecular diagnostics. Rosetta’s
integrative research platform combining bioinformatics and
state-of-the-art laboratory processes has led to the discovery of
hundreds of biologically validated novel human microRNAs. Building
on its strong patent position and proprietary platform
technologies, Rosetta is working on the application of these
technologies in the development and commercialization of a full
range of microRNA-based diagnostic tools. Through the acquisition
of PersonalizeDx, Rosetta offers core FISH, IHC and PCR-based
testing capabilities and partnerships in oncology and urology that
provide additional content and platforms that complement the
Rosetta offerings. Rosetta’s and PersonalizeDx’s cancer testing
services are commercially available through the Philadelphia, PA-
and Lake Forest, CA-based CAP-accredited, CLIA-certified labs,
respectively. For more information visit www.rosettagx.com.
About Biocept
Biocept, Inc. is a commercial-stage molecular diagnostics
company that utilizes a proprietary technology platform and a
standard blood sample to provide physicians with important
prognostic and predictive information to enhance individual
treatment of patients with cancer. Biocept’s patented technology
platform captures and analyzes circulating tumor DNA, both in CTCs
and in plasma (ctDNA). Biocept currently offers assays for gastric
cancer, breast cancer, lung cancer, colorectal cancer and melanoma,
and plans to introduce CLIA-validated assays for prostate cancer
and other solid tumors in the near term. For additional
information, please visit www.biocept.com.
Rosetta Genomics Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future
expectations, plans and prospects, including but not limited
to statements that the collaboration between Rosetta and
Biocept will be successful and expand the role and utility of
microRNA signatures in treating cancer, that the collaboration
between Rosetta and Biocept will lead to the development of
advanced diagnostics, Rosetta’s expectations regarding the market
size for its diagnostic testing services and Rosetta’s ability to
develop and commercialize microRNA-based diagnostic tools
constitute forward-looking statements for the purposes of the safe
harbor provisions under The Private Securities Litigation Reform
Act of 1995. Actual results may differ materially from those
indicated by these forward-looking statements as a result of
various important factors, including those risks more fully
discussed in the "Risk Factors" section of Rosetta’s Annual Report
on Form 20-F for the year ended December 31, 2014 as filed
with the Securities and Exchange Commission (SEC). In addition, any
forward-looking statements represent Rosetta’s views only as of the
date of this release and should not be relied upon as representing
its views as of any subsequent date. Rosetta does not assume any
obligation to update any forward-looking statements unless required
by law.
Biocept 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 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," "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 the collaboration between
Rosetta and Biocept being successful and expanding the role and
utility of microRNA signatures in treating cancer, the
collaboration between Rosetta and Biocept leading to the
development of advanced diagnostics, Biocept being able to improve
the detection and treatment of cancer and enhance individual
treatment of patients 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 risk factors as set forth in Biocept’s 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. 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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version on businesswire.com: http://www.businesswire.com/news/home/20151214005402/en/
Rosetta Genomics:Ken Berlin, President & CEO,
609-419-9003investors@rosettagenomics.comorRosetta Genomics
Investors:LHAAnne Marie Fields,
212-838-3777afields@lhai.comorBiocept Investors:LHAJody
Cain, 310-691-7100jcain@lhai.com
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