Trovagene Announces Plans to Develop Proprietary Test for High Risk HPV Carrier Screening from Urine

   Trovagene Announces Plans to Develop Proprietary Test for High Risk HPV
                         Carrier Screening from Urine

PR Newswire

SAN DIEGO, May 2, 2012

SAN DIEGO, May 2, 2012 /PRNewswire/ -- Trovagene, Inc. (Pink Sheets: TROV)
announced today that the Company has initiated development of a diagnostic
test to determine the presence of high risk Human Papilloma Virus (HPV)
subtypes from urine specimens. The proprietary test (U.S. patent application
pending) might, once available, be particularly useful for the determination
of carrier status in males.

The Company's HPV detection assay is a unique, proprietary(1) method that
preferentially amplifies a specific region of the HPV genome of high risk HPV
types, but not of low risk types. In an explorative validation study the
Company has compared the analytical performance of its assay, which uses urine
as the sample, to a commercially available HPV test, which uses cytology
samples and was performed according to the manufacturer's protocol. Discordant
results were resolved by Sanger DNA sequencing. The results showed that the
Trovagene assay performed with a sensitivity of 93% and a specificity of 96%,
whereas the commercially available LBC test had a sensitivity of 78% and a
specificity of 86%.

Trovagene's HPV assay is compatible with the throughput and reliability
requirements of a clinical-diagnostic laboratory at very competitive cost
levels. The Company believes that the detection of high risk HPV types through
its urine-based assay could have valuable clinical utility for monitoring the
high risk HPV carrier status of an individual. Such infections can lead to
cervical cancer, head-and neck cancer(2), and other cancers.

Charlie Rodi, Ph.D., Trovagene's Chief Technology Officer, stated that "the
Company's HPV assay technology is noteworthy for both its high performance and
its ease of use. The urine sample can be collected in private and shipped at
ambient temperatures to a diagnostic laboratory." He also noted that although
there is no HPV test currently recommended for use by men, that the Company's
urine-based test has the potential to determine male carrier status without
resorting to methods that require scraping to collect cytology samples. Dr.
Rodi added that the Company plans to begin offering the test in 2012.

1. WO2010051261, IPA No. PCT/US2009/062114, Indian Patent Application No.
3673/DELNP/2011

2. Chaturvedi AK, Engels EA, Pfeiffer RM, et al. Human papillomavirus and
rising oropharyngeal cancer incidence in the United States (2011) Journal of
Clinical Oncology 29(32): 4294-4301.

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 dominant 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 myeloid leukemia
(AML) and mutations in the SF3B1 gene, which have been shown to be associated
with chemotherapy response in CLL (chronic lymphocytic leukemia) 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.

Contacts

Trovagene, Inc.
Stephen Zaniboni
Chief Financial Officer
+1 (858) 496-7466
szaniboni@trovagene.com
http://www.trovagene.com

SOURCE Trovagene, Inc.