Rosetta Genomics Completes Acquisition of PersonalizeDx
April 14 2015 - 8:30AM
Business Wire
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostics,
announces the closing of its acquisition of CynoGen, Inc. (d/b/a
PersonalizeDx) from Prelude Corporation.
“We are delighted to complete this important, strategic
acquisition and look forward to integrating PersonalizeDx into
Rosetta Genomics,” said Kenneth A. Berlin, President and Chief
Executive Officer of Rosetta Genomics. “There are multiple areas of
product synergies between these two businesses, notably in urologic
and lung cancers. Furthermore, including the PersonalizeDx
pipeline, Rosetta Genomics is poised to launch five novel,
differentiated assays within the next 12 months. This acquisition
and the near term product launches will provide a foundation for
growth well into the future and will expand our leadership position
in bringing to market differentiated content in the area of
personalized medicine.”
PersonalizeDx is a rapidly growing molecular diagnostics and
services company serving community-based pathologists, urologists,
oncologists and other reference laboratories across the U.S.
PersonalizeDx recorded revenues for 2014 of $6.9 million
(unaudited), a nearly three-fold increase compared with 2013
(unaudited). Through this transaction Rosetta Genomics gains
proprietary tests in prostate, bladder and lung cancer, strong
commercial and laboratory operations capabilities and a
state-of-the-art, high-complexity CLIA laboratory in Lake Forest,
California.
“The complementary molecular test offerings of PersonalizeDx and
Rosetta Genomics will allow us to provide urologists with a broad
range of unique solutions for the various tumor types they treat,
and assist with difficult clinical decisions for their prostate,
bladder and kidney cancer patients,” said Chris Emery, General
Manager of PersonalizeDx. “We are also excited for the combined
companies to maximize the commercial potential of the current
PersonalizeDx offerings and pipeline opportunities in lung and
breast cancer,” he added.
PersonalizeDx is focused on the detection of genomic changes
through FISH technology, which helps to detect cancer, measure the
potential aggressiveness of the disease and identify patients most
likely to respond to targeted therapies. The company offers a “FISH
Local” technical-only service option for all of its FISH-based
tests, which allows pathologists to deliver expert case results to
oncologists and urologists through reports that are customizable to
the local pathology brand. The FISH service offered by
PersonalizeDx is best-in-class with a highly competitive success
rate in obtaining informative FISH results of 98% and excellent
turnaround time of three to four days.
PersonalizeDx has the following additional novel content, which
enables clinicians to practice personalized medicine:
- ERG is a proprietary prognostic test
for patients with prostate cancer that provides urologists with
results of favorable versus poor prognosis to help inform the
decision to proceed with surgery or active surveillance. This
product is available as a global or technical-only FISH service and
is offered in combination with PTEN for a comprehensive overall
prognostic assessment. ERG was launched in 2014 and the annual U.S.
market for ERG/PTEN testing is approximately $100 million.
- FGFR3 mutation analysis identifies
low-grade bladder cancer from urine and tissue-based specimens.
Test results help urologists to monitor patients, and also assist
with prognosis and tumor grading. When used in conjunction with the
company’s leading FISH testing, the combined offering will provide
a highly sensitive and specific diagnostic test for all stages of
bladder cancer. FGFR3 addresses an annual U.S. market opportunity
of approximately $250 million and is expected to launch prior to
the end of 2015.
In addition to these differentiated products, in connection with
this transaction Rosetta Genomics gains certain rights to market
Prelude’s novel assay for ductal carcinoma in situ (DCIS). Prelude
DCIS is a novel, proprietary prognostic test for breast cancer with
the goal of decreasing radiation overtreatment in patients with
DCIS (stage 0 breast cancer). This product differentiates DCIS
patients at high risk versus low risk for recurrence, as well as
DCIS patients who are likely to respond to therapy versus those who
are not likely to respond. Prelude DCIS addresses an approximate
$200 million annual U.S. market opportunity. Rosetta Genomics
expects to market Prelude DCIS as a laboratory developed test
within the next six months.
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic
testing services offered by Rosetta Genomics. The Rosetta Cancer
Origin Test™ can accurately identify the primary tumor type in
primary and metastatic cancer including cancer of unknown or
uncertain primary (CUP). The Rosetta Lung Cancer Test™ accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately
classifies the four most common kidney tumors: clear cell renal
cell carcinoma (RCC), papillary RCC, chromophobe RCC and
oncocytoma. Rosetta’s assays are designed to provide objective
diagnostic data; it is the treating physician’s responsibility to
diagnose and administer the appropriate treatment. In the U.S.
alone, Rosetta Genomics estimates that 200,000 patients a year may
benefit from the Rosetta Cancer Origin Test™, 65,000 from the
Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta
Lung Cancer Test™. The Company’s assays are offered directly by
Rosetta Genomics in the U.S., and through distributors around the
world. In addition, Rosetta markets the Rosetta Genomics PGxOne™
test and the EGFR and KRAS sequencing services for Admera Health.
For more information, please visit www.rosettagenomics.com. Parties
interested in ordering any of these tests should contact Rosetta
Genomics at (215) 382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of
microRNA-based molecular diagnostics. Founded in 2000, 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. Rosetta’s cancer testing
services are commercially available through its Philadelphia-based
CAP-accredited, CLIA-certified lab.
Forward-Looking Statement Disclaimer
Various statements in this news release concerning Rosetta’s
future expectations, plans and prospects, including without
limitation, that Rosetta will launch five assays within the next 12
months, that the acquisition of PersonalizeDx and the near term
product launches will provide a foundation for growth well into the
future and will expand Rosetta’s leadership position , the timing
of commercial launch of the FGFR3 test and the Prelude DCIS test,
the potential market opportunities for certain tests and services,
and that the combined companies will maximize the commercial
potential of the current PersonalizeDx offerings and pipeline
opportunities, 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 SEC. In addition, any forward-looking statements
represent Rosetta’s views only as of the date of this news 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.
Rosetta Genomics Ltd.Ken Berlin, 609-419-9003President
& CEOinvestors@rosettagenomics.comorInvestorsLHAAnne
Marie Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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