-
‣Product Development
TrovaGene is developing a transrenal molecular diagnostic assay platform ideal for human in-vitro diagnostic testing. Proof of principle experiments have been completed for each of four major clinical applications: cancer detection and monitoring, infectious disease testing, organ transplant rejection monitoring and non-invasive prenatal genetic testing.
TrovaGene is currently focusing its product development efforts on diagnostic assays for the early detection and identification of infectious diseases.
Within infectious disease, our short-term priority is to leverage our HPV-related “Freedom To Operate” incorporating our extremely unique primer pair and novel approach to amplifying high risk HPV types pervasive within the E1 genomic region, in conjunction with our previous clinical success with an HPV urine-based assay, to further develop and subsequently commercialize a simple, non-invasive and convenient HPV test with the utmost of sensitivity and specificity. Such a test could be completed in the privacy of the patient’s own home. Our HPV test, once commercialized, would provide an ideal means to predict cervical cancer risk.
Aside from urine, TrovaGene intends to maximize the value of our aforementioned “Freedom To Operate” by developing tests employing other HPV screening specimens (i.e. cervical and/or self collection). This will be accomplished most likely with corporate partners.
Secondarily within infectious diseases, we will develop and leverage our tests to screen for, detect, identify and monitor for opportunistic infections in immunosuppressed patients. This will incorporate immunosuppression caused by disease as well patients treated with immunosuppressive therapy (i.e. tumor necrosis factor (TNF) inhibitors, inhibitors of various integrin subtypes, etc.).
Our simple tests will detect viruses (i.e., JC virus, BK virus, HBV, etc.), opportunistic fungal infections (i.e. Candidiasis, Aspergillosis, etc.), bacteria (i.e. meningitis, etc.). In addition, we are developing infectious disease assays for diseases with high unmet market need (i.e. chronic undiagnosed Lyme Disease).
HPV Assay
TrovaGene has completed a pilot clinical study with a urine-based DNA test. The initial data clearly shows that the TrovaGene developed assay provides comparable if not superior performance to the current market leader’s assay. Urine based HPV testing offers a significant advantage for the identification of HPV where cervical swab sample collection presents a logistic, invasive or privacy concern.
We have completed a clinical study protocol after consulting Key Opinion Leaders in the US and Europe. In 2011, we are commencing a clinical validation study which eventually will lead to clearance of our test by the European regulatory agency and subsequent commercialization in Europe. Commercialization in other geographies where compliance with cervical swabs is problematic (i.e. Asia) will subsequently be pursued.
JC Virus Assay
Progressive multifocal leukoencephalopathy (PML) is a fatal demyelinating disease of the brain which occurs in immunosuppressed individuals and is caused by JC virus (JCV). Recent publications have clearly elucidated certain mutations in the virus VP-1 gene and the role this mutant gene plays in enabling the virus to infect oligodendrocytes in the brain.
TrovaGene has been developing a series of real-time PCR assays which allow the sensitive identification of persistent but asymptomatic JC virus. The assays are suitable for urine, blood, and spinal tap-based specimens.
Multi-Analyte Assay for Opportunistic Infections
An area with a high unmet market need involves opportunistic infections in immunocomprimised patients, either due to disease or drug therapy (i.e. patients treated with immunosuppressive drugs such as TNF (tumor necrosis factor) or integrin inhibitors. These drug classes are used for treating such conditions as rheumatoid arthritis, multiple sclerosis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease.
In September 2008, the U.S. Food and Drug Administration (FDA) issued a warning that patients on TNF inhibitors are at increased risk of opportunistic fungal infections, such as pulmonary and disseminated histoplasmosis, coccidioidomycosis, and blastomycosis. They encourage clinicians to consider empiric antifungal therapy in all patients at risk until the pathogen is identified.
Trovagene is developing assays to test for various bacterial, fungal and viral pathogens frequently implicated in opportunistic infections. Our robust and simple tests will enable patient monitoring and proactive intervention when necessary, avoiding the need for costly empiric treatment with antibiotics, antifungals and/or antivirals. The integrin inhibitors have also encountered major hurdles due to opportunistic infection risks. One such product has been pulled from the US market and another product has a “black box” warning and heavily restricted distribution, all due to infection risks.
Lyme Disease Assay
One of the important infectious disease assays that TrovaGene has targeted for development and introduction to the market is a test to aid in the differential diagnosis of patients with Lyme disease. This disease is particularly difficult to diagnose, often leading to misdiagnoses, prolonged infection and ultimately a more severe form of the disease. The intent of the assay is for the early and accurate detection of the organism which causes this disease. Additionally, we will validate the test in patients suffering from vague symptoms which may point to a chronic infection that was not properly diagnosed and treated. Our urine-based test is ideally suited for these circumstances.
Screening for mutation profiles and expression signatures implicated in various cancers
Longer term, TrovaGene will develop, most likely in conjunction with a partner, urine-based assays to detect mutations or signature profiles implicated in solid or hematologic cancers. These assays would be extremely useful as an aid in the personalized management of patients with various types of cancer including colorectal, breast, lung, pancreatic, etc. The information from these assays will lead to better personalized medicine so that the right patient gets the right treatments based on their genetic profile. Our tests will also be ideal in those circumstances where regular monitoring is required (i.e. for treatment success or failure, relapse/recurrence, etc. We are especially excited by the applicability and prospects for our tests with miRNA in the detection of cancer-related signature profiles.
TROV.PK
For more information on partnering opportunities please contact busdev@trovagene.com.
TROVAGENE INC (TROV.PK)
