Navigation Links
Trovagene Announces Commercial Launch Timelines for HPV Carrier and Oncogene Mutation Tests

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.


Trovagene, Inc.
Amy Caterina
Investor Relations
+1 (858) 952-7593 

SOURCE Trovagene, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Trovagene to Introduce First Urine-Based Molecular Diagnostic Test for Transrenal Cancer Mutation Monitoring
2. Trovagene and Barretos Cancer Hospital, Brazil, to Evaluate Urine-Based HPV Assay as Potential Pap Smear Replacement
3. Trovagene Announces Closing of Private Placement of $3.76 Million from the Sale of Restricted Common Stock and Warrants
4. Dr. Paul Billings joins Trovagenes Scientific Advisory Board
5. Trovagene, Inc., Announces Third Quarter and Year to Date Earnings, Provides Milestone Update
6. Trovagene and Strand Life Sciences Agree to Validate and Commercialize Urine-Based HPV Test in India and South Asia
7. Trovagene, Inc. Announces Second Quarter and Year to Date Earnings, Provides Milestone Update
8. Trovagene, Inc., Announces Issuance of U.S. Patent for NPM Mutants to Diagnose and Monitor Acute Myeloid Leukemia
9. Trovagene to Study Trans-Renal KRAS Mutation Detection in Pancreatic Cancer
10. Trovagene Announces Plans to Develop Proprietary Test for High Risk HPV Carrier Screening from Urine
11. Keith McCormick Joins Trovagene, Inc. as Head of Commercial Operations
Post Your Comments:
(Date:11/29/2015)... , Nov. 29, 2015   Royal Philips  ... driven radiology solutions at the 2015 Radiological Society of ... 4 at McCormick Place in Chicago ... will experience the company,s broad portfolio of integrated Diagnostic ... solutions to increase clinical performance, improve workflow and create ...
(Date:11/29/2015)... Germany , Nov. 29, 2015  At this ... attendees to experience the most complete mobile C-arm portfolio ... display is Ziehm Vision RFD 3D, the world,s only ... cm edge length per scan volume. In addition, Ziehm ... fully motorized mobile C-arm in four axes which is ...
(Date:11/29/2015)...  The GE Health Cloud 1 was unveiled today ... North America (RSNA) meeting in ... new cloud ecosystem and its applications will connect radiologists and ... multidisciplinary teams – both inside and outside the hospital setting. ... GE. "As the digital industrial leader, we are betting big ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question ... from last year? , This question has not been an easy question to answer. ... retirement age and the younger workforce don’t share the same discipline around working long ...
(Date:11/27/2015)... ... November 27, 2015 , ... The rapid speed at which ... age, more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions ... overworked. The forgotten part of this equation: 80 percent of medical care occurs ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Lizzie’s Lice Pickers ... company is offering customers 10% off of their purchase of lice treatment product. In ... full price. According to a company spokesperson. “Finding lice is a sure way to ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... through sharing, the 2016 Building Better Radiology Marketing Programs meeting will ... on Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... innovative online platform for mental health and wellness consultation, has collaborated with a ... will bridge the knowledge gap experienced by parents and bring advice from parenting ...
Breaking Medicine News(10 mins):