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.
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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.
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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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