Our R&D Pipeline

Trovagene intends to develop and expand its transrenal molecular technology into a pipeline of potentially groundbreaking commercial medical testing and screening products that will be an integral part of the projected growth in personalized medicine over the next five to ten years.

Planned Assays

Assays in Development

Trovagene will develop urine-based assays to detect mutations or signature profiles implicated in both solid and hematologic cancers. These assays may prove extremely useful as an aid in the personalized management of patients with various types of cancer including colorectal, breast, lung, pancreatic, etc. These tests will be ideal in those circumstances where regular monitoring is recommended, including for treatment response, non-response, or recurrence.

The first three assays in development include KRAS, BRAF and PIK3CA. These mutations have a broad applicability across numerous cancers – and in the case of KRAS and BRAF there are already several targeted therapies on the market today where treatment response or non-response is dependent upon the presence or absence of these mutations in primary or metastatic cancers. The following chart summarizes the US-only market for these three mutations, covering more than 2 million individual cancer patients who could potentially benefit from this technology.

Forthcoming Services

Transrenal molecular testing will make it easier to address important health problems worldwide and will lead to significant advances in personalized medicine for improved patient care. Trovagene anticipates that TrNA analysis will have great utility in monitoring oncogene mutations following treatment, for detection of minimal residual disease, and for early detection of recurrence. Since TrNA analysis uses a truly non-invasive sample, it may replace the need to perform serial tissue biopsies and blood and bone marrow tests; as well as CT, MRI and PET scans conducted for monitoring purposes.

Assays planned to be available through Trovagene's CLIA laboratory include:

• KRAS mutation detection and monitoring: These mutations are frequently found in pancreatic, colorectal, lung, and ovarian cancers, among others. This test, which will monitor KRAS mutations in TrNA, is planned for launch in early 2013.

• BRAF mutation detection and monitoring: Found frequently in skin, thyroid, and colon cancers as well as in hairy cell leukemia

• PIK3CA mutation detection and monitoring: These mutations occur frequently in cancers of the breast, colon, and endometrium.

• NPM1 detection and monitoring: This marker has been linked to the prognosis of patients with acute myelogenous leukemia (AML).

• SF3B1 in Chronic Lymphocytic Leukemia: Mutations in the SF3B1 gene have been shown to be associated with chemotherapy response in CLL (chronic lymphocytic leukemia) patients. Trovagene is further developing the clinical application of these mutations with key opinion leaders in the US.

• HPV Assay: This assay is being transfered to our CLIA laboratory for commercial use. Our proprietary test amplifies the E1 genomic region of high risk HPV types. In a 320 patient trial, presented at the 2010 AACC meeting, the test had a sensitivity of 93% and a specificity of 96%,

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We plan to leverage the CLIA laboratory operations as a development and commercialization platform for novel tests intended to detect minimal residual disease in oncology, based on tumor-specific mutations detectable in a patient's urine.

Antonius Schuh, Ph.D. Chief Executive Officer