Rosetta Genomics has
developed a suite of microRNA-based diagnostics that were discovered through the
company’s proprietary microRNAs and platform technologies. These technologies
have made considerable headway in the medical field, demonstrating how
microRNAs have the potential to accurately diagnose and classify cancer, as
well as to identify the origin of metastases, or where the cancer originated in
the body.
Founded in 2000, Rosetta can
be credited with building the field of microRNAs, and was one of the first to
demonstrate that serum microRNAs can be novel biomarkers, which are molecular
“flags” indicative of a biological state or condition. Thus far, the company
has discovered more than 300 biologically validated novel human microRNAs.
This discovery is
significant, considering that microRNAs have already demonstrated potential to
revolutionize cancer diagnostics. The company has also identified microRNAs’ central
role to a host of other conditions, including autoimmune and inflammatory
diseases, cardiovascular diseases, diabetes and obesity, infectious diseases,
and neurological disorders.
Rosetta’s technologies are
packed into an intellectual property portfolio that currently consists of 33
issued patents, two allowed patents, and 46 patent applications. Building on
this strong patent position and proprietary platform technologies, Rosetta is
working to apply these technologies in the development and commercialization of
a full range of microRNA-based diagnostic tools.
Rosetta currently has four
revenue-generating microRNA-based diagnostic tests targeting: cancer origin;
lung cancer; kidney cancer; and mesothelioma, a form of cancer most commonly
found in the chest and abdomen, generally connected to asbestos exposure.
• The Rosetta Cancer Origin Test™ accurately identifies the
primary tumor type in primary and metastatic cancer by measuring the expression
levels of 64 microRNAs, which are then processed through the company’s
proprietary algorithm. The test results can accurately identify the origin of
the patients’ tumor for 49 cancer origins with 85% sensitivity and 99%
specificity. By determining cancer origin, clinicians can better diagnose
patients and determine optimal treatment options.
• The Rosetta Lung Cancer Test™ accurately identifies the
four main subtypes of lung cancer: squamous Non-Small Cell Lung Cancer (NSCLC),
non-squamous NSCLC, Small Cell Lung Cancer or carcinoid. The test is based on the
expression level of eight microRNAs extracted via cytological procedures such
as fine-needle aspiration (FNA), bronchial brushing and washing, and biopsy
sample.
• The Rosetta Kidney Cancer Test™ uses 24 microRNAs to
accurately classify the four most common kidney tumors: Clear cell RCC,
Papillary RCC, Chromophobe RCC, and benign Oncocytoma. A validation set of 201
independent samples was classified using the test and analyzed blindly. The
test produced results for 92% of the samples with an accuracy of 95%.
• The Rosetta Mesothelioma Test™ leverages the high
specificity of microRNAs as biomarkers to differentiate mesothelioma, a
malignant tumor connected to asbestos exposure, from carcinomas in the lung and
pleura, a medically and legally important differential diagnosis.
Distinguishing between the two conditions is vital, and allows for specific and
treatment regimens for each condition. Currently there is no other single
diagnostic test that is conclusive for this differentiation.
Cancer obviously isn’t
constrained by geological boundaries, and to capture its portion of the global
diagnostics market Rosetta offers its four commercial-stage oncology tests in
multiple countries around the world; implemented a global comprehensive sales
and marketing effort for its cancer origin test; obtained Medicare and private
pay coverage for the origin test; initiated a master service provider agreement
with a global biopharmaceutical company; and plans to execute collaboration
deals with additional pharma/biotech and Dx companies.
In 2013, Rosetta raised more
than $3 million in financing and at year-end reported more than $20 million in
cash, which the company says is enough to fund operations well into 2015.
Furthermore, the company has no debt.
These factors position
Rosetta with room to leverage microRNAs as stable, sensitive, and specific
markers, and to advance and develop multiple diagnostic programs in cancer and
for various other indications to enable accurate diagnosis and targeted
treatment. The company’s current product pipeline consists of programs in
various stages of development and/or marketing: thyroid neoplasia, the
company’s lead product with launch expected in 205; bladder, ovarian and breast
cancers; heart failure, kidney rejection; Alzheimer’s disease; and
cytomegalovirus (CMV) therapeutics.
For more information visit
www.rosettagenomics.com
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