Trovagene to Introduce First Urine-Based Molecular Diagnostic Test for Transrenal Cancer Mutation Monitoring

    Trovagene to Introduce First Urine-Based Molecular Diagnostic Test for
                    Transrenal Cancer Mutation Monitoring

PR Newswire

SAN DIEGO, Nov. 28, 2012

SAN DIEGO, Nov. 28, 2012 /PRNewswire/ --Trovagene, Inc. (NASDAQ: TROV) today
announced successful development of its first molecular diagnostic test
capable of detecting KRAS mutations from a urine specimen. Transfer of the
transrenal KRAS test to the company's CLIA lab is expected to be completed in
December 2012 with commercial availability expected in January 2013.

(Logo: http://photos.prnewswire.com/prnh/20120620/LA28014LOGO)

"Our scientific team has developed the first commercially viable process for
quantitative detection of KRAS mutations in transrenal DNA isolated from a
simple urine specimen," said Charlie Rodi, Ph.D., chief technology officer of
Trovagene. "This represents a breakthrough in cancer monitoring, and will
provide oncologists and surgeons with the ability to frequently check mutation
status before, during, and after therapy."

Cell-free nucleic acids originate from both normal and diseased cells,
circulate through the bloodstream, cross the kidney barrier, and can be
detected in urine as transrenal DNA. As interest in this technology grows
among leading academic cancer centers, Trovagene continues to engage with new
collaborators to develop a series of transrenal molecular diagnostic tests to
detect and monitor cancer mutations. Trovagene's initial oncogene mutation
tests will include KRAS, BRAF and PIK3CA. Potential uses of this non-invasive
technology include monitoring for recurrence of disease, determining response
to therapy and disease detection.

Solid tumors represent more than 90% of all cancers, and approximately 24% of
these are KRAS mutation positive. Based on current cancer incidence rates in
the US, each year an estimated 360,000 newly diagnosed patients are expected
to have KRAS mutation-positive cancers.

"Over the next six months, we plan to introduce a variety of assays that may
offer significant clinical benefits for physicians and patients, as well as
potential savings for the healthcare system," stated Antonius Schuh, Ph.D.,
chief executive officer of Trovagene. "The ability to test, detect and confirm
cancer mutation status non-invasively represents an enabling technology that
can be used across a variety of clinical applications."

Clinicians interested in utilizing the transrenal KRAS test should contact
Trovagene Client Services at 888-391-7992.

About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is developing its patented
technology for the detection of transrenal DNA and RNA, short nucleic acid
fragments, originating from normal and diseased cell death that cross the
kidney barrier and can be detected in urine. Trovagene has a strong patent
position as it relates to transrenal molecular testing. It has U.S. and
European patent applications and issued patents that cover testing for HPV and
other infectious diseases, cancer, transplantation, prenatal and genetic
testing. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an
informative biomarker for acute myelogenous leukemia (AML) and mutations in
the SF3B1 gene, which have been shown to be associated with chemotherapy
response in chronic lymphocytic leukemia (CLL) patients.

Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimated" and "intend," among others.
These forward-looking statements are based on Trovagene's current expectations
and actual results could differ materially. There are a number of factors that
could cause actual events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not limited to,
substantial competition; our ability to continue as a going concern; our need
for additional financing; uncertainties of patent protection and litigation;
uncertainties of government or third party payer reimbursement; limited sales
and marketing efforts and dependence upon third parties; and risks related to
failure to obtain FDA clearances or approvals and noncompliance with FDA
regulations. As with any medical diagnostic tests under development, there are
significant risks in the development, regulatory approval and
commercialization of new products. There are no guarantees that future
clinical trials discussed in this press release will be completed or
successful or that any product will receive regulatory approval for any
indication or prove to be commercially successful. Trovagene does not
undertake an obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in Trovagene's Form 10-K for
the year ended December 31, 2011 and other periodic reports filed with the
Securities and Exchange Commission.

Contact

Trovagene, Inc.
Investor Relations
Amy Caterina
Investor Relations
Trovagene, Inc.
858-952-7593
acaterina@trovagene.com

SOURCE Trovagene, Inc.

Website: http://www.trovagene.com
 
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