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‣Business Strategy
Our short-term strategy is to leverage, with corporate partners where appropriate, our proprietary urine-based nucleic acid testing platform toward the development of diagnostic assays for the screening of infectious diseases. In this regard, our initial priority is to leverage our extremely unique primer pair and novel approach to amplifying high risk HPV types through the E1 region of the HPV genome, and associated “Freedom to Operate” of our cutting edge method, toward the development and commercialization of a simple, non-invasive and cost-effective HPV screening test.
Although our HPV assay is conducive to any specimen (i.e. cervical swab, self-sampling and urine), our initial focus is to employ urine samples to further leverage our very positive clinical data using this particular specimen. Such a urine-based HPV test will offer a non-invasive and convenient (i.e. home-based test) screening option for high-risk HPV types (high risk as defined by that most-likely to be a precursor to cervical cancer). Many women are non-compliant with their doctors’ recommendations to have regular Pap screening, primarily because of the invasive nature of the existing tests that are based on cervical scrapings. Our non-invasive urine-based HPV test should undoubtedly address a huge unmet market need by significantly improving compliance and in turn reducing the incidence of cervical cancer.
Secondarily in the area of infectious diseases, we intend to develop our convenient and robust tests for the screening and periodic monitoring of immunocompromised patients for the onset of opportunistic infections. This will allow for quick differential diagnosis, including identification of the causative pathogens and proactive intervention including the start of the most appropriate anti-infectives. Our tests should serve to reduce the morbidity and mortality associated with such opportunistic infections, and reduce the expenses related to expensive empirical therapy.
In conjunction with corporate partners, we will expand our development and commercialization to include urine-based nucleic acid tests for cancer This could include the identification of miRNA expression profiles or mutant RNA/DNA, all with a focus toward improving detection, prognostics, treatment selection, and the monitoring of treatment response and disease recurrence, all with a goal of enhancing personalized medicine for these patients.
Introduction
TrovaGene’s core business will capitalize on the strong intellectual property position it has created in patent protected transrenal nucleic acid detection and analysis. Leveraging this IP we intend to develop unique molecular diagnostic assays that target a novel class of biomarkers in urine. We will focus initially on the development of molecular diagnostic assays detecting somatic mutations remotely originating from solid cancers and molecular targets associated with infectious diseases. Assays, for example, that detect tumor-specific biomarkers in urine will lead to unique opportunities making it easier to monitor disease progress, patient response to therapy, and tumor relapse. We believe transrenal molecular assays will improve the patient experience and provide information that can be used to advance personalized medicine for all patients. This personalized medicine approach will lead to improved treatments with the right drug at the right time and improved outcomes and quality of life for the individual patient.
The Market Opportunity
Transrenal molecular diagnostics will provide relevant diagnostic information that will lead to improvements in personalized patient management. The worldwide market for molecular testing was $3.7 billion in 2007 and is projected to increase to $6.2 billion by 2012. The market for personalized health and wellness is expected to grow to $452 billion by 2015. The core diagnostic and therapeutic segment of this market is projected to grow to $24 billion in that same time period. Cancer management is where most of the progress in personalized medicine has occurred to-date. New products that facilitate personalized care are emerging in the areas of cardiology, CNS, autism, diabetes, and depression.
TrovaGene intends to develop and expand its platform of transrenal molecular technology platform into a pipeline of potentially groundbreaking commercial medical testing and screening products that will be an integral part of this projected growth in personalized medicine.
Developing World-class Diagnostics
The applicability of our transrenal DNA and RNA IP in the human in-vitro diagnostics market is broad. To capitalize on its potential we will establish partnerships with international diagnostic companies that have the capability of bringing our technology to the global clinical markets in the form of relevant diagnostic products. This will be enhanced by the early introduction of products for research use in order to inform and enable development of a broad range of potentially important commercial applications in international markets.
TrovaGene believes that transrenal molecular diagnostic applications will provide inroads into markets that are currently limited by the difficulty of obtaining testing specimens. Current difficulties include the amount or type of bodily fluid or sample required, the need for preservation or refrigeration for certain samples, transportation or portability difficulties, and certain cultural limitations that may impair sample collection such as those required for HPV testing.
Through licensing our IP, partnering with global diagnostic companies, and our own assay development efforts we expect transrenal DNA and RNA diagnostic testing to make a significant contribution to healthcare and the progression to personalized medicine.
TROV.PK
TROVAGENE INC (TROV.PK)
