Trovagene Announces Commercial Launch Timelines for HPV Carrier and Oncogene
SAN DIEGO, Feb. 12, 2013
SAN DIEGO, Feb. 12, 2013 /PRNewswire/ --Trovagene, Inc. (NASDAQ:TROV) today
announced that the development of its proprietary, urine-based HPV carrier
screening test is progressing well and the Company expects to achieve
analytical and clinical validation of the test in its CLIA laboratory in March
2013. When validation is completed, the test will be available to clinicians
and their patients. In addition to the ongoing HPV validation studies, one
clinical trial has been completed in India and two additional trials are
underway in collaboration with the Barretos Cancer Center, Brazil and Strand
Life Sciences, India.
The Company has extended its planned offering of urine-based oncogene mutation
tests for 2013 to include a test for the detection of a specific p53 mutation
and a specific double mutation in the hepatitis B virus (HBV). Both markers
are strongly associated with hepatocellular carcinoma (HCC), which is the
third leading cause of cancer mortality worldwide. Availability of the HCC
test is anticipated in the fourth quarter of 2013. Trovagene's KRAS oncogene
mutation test is expected to be introduced in the second quarter 2013. In
support of the Company's BRAF oncogene mutation test, a clinical trial with MD
Anderson focused on mutations in patients with advanced or metastatic cancers
is ongoing. It is anticipated that sufficient clinical specimens will be
obtained to support a third quarter offering of this test. Additional clinical
studies, including a trial to evaluate the detection of PIK3CA oncogene
mutations, are in preparation.
On February 13, 2013, at 9 a.m. ET, Trovagene will present at the Leerink Swan
Global Healthcare Conference hosted at the Waldorf Astoria Hotel in New York
City. A pdf file of the conference presentation will be available at
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 is leveraging its
intellectual property in oncogene mutations via out-licensing and use of its
transrenal technologies to extend oncogene mutation detection using urine as a
sample. As a non-invasive and abundant sample, urine may overcome many of the
cost and collection challenges associated with biopsy, as well as the volume
limitations of blood.
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, as well as other hematologic malignancies.
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.
+1 (858) 952-7593
SOURCE Trovagene, Inc.
Press spacebar to pause and continue. Press esc to stop.