Introduction

Trovagene is developing transrenal molecular assays ideal for human in vitro diagnostics. We are focused on four major clinical applications areas: cancer mutation detection and monitoring, organ transplant rejection monitoring, infectious disease testing and non-invasive prenatal genetic testing.

What are Transrenal Nucleic Acids (TrNAs)?

In the human body about 10¹¹ - 10¹² cells die each day primarily as a consequence of physiological programs for tissue and organ maintenance, but also as a result of disease processes. Together, these dead and dying cells contain more than 1 gram of DNA, which is mostly degraded into short fragments by specific enzymes.

A small proportion of these cell-free nucleic acids escape complete degradation and appear in the bloodstream. Scientists at Trovagene were the first to discover that circulating cell-free nucleic acids cross the kidney barrier and can be found in the urine as TrNAs. This simple yet remarkable discovery that genetic information from various cells throughout the body is present in urine enabled the development of new, noninvasive techniques for molecular diagnostics and genetic testing.

How can TrNAs be used in diagnostics?

Determing DNA and RNA signatures using urine as a "systemic biopsy" may provide a more powerful and effective tool for following and uncovering both pre-clinical and clinical changes, e.g.:

Monitoring cancer patients to determine therapeutic response or non-response and disease recurrence.
Following organ transplant status must to watch for rejection.
Non-invasively securing samples for the clinical diagnosis of infectious diseases.
Screening and testing expectant mothers who are at risk for certain genetic abnormalities.

Currently, these clinical needs are met by invasive blood and bone marrow tests, tissue biopsies, amniocentesis along with costly CT, MRI and PET scans.

Isolation of Nucleic Acids from Urine

Urine is a relatively simple aqueous solution and, unlike plasma, contains few components that can attack and break down TrNA fragments. Since urine does not contain many cells, proteins and other contaminants, isolation of TrNA isolation is a procedure which can be easily automated for high throughput screening applications. These TrNA fragments can be accurately analyzed using conventional methods that are either in use or in development within many molecular genomics laboratories.

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Major clinical application areas:

Oncology
Transplant
Infectious Disease
Prenatal Genetics

TrNA Overview:

Presence in urine first discovered by Trovagene scientists
Released by millions of dying cells everyday
Comprise >1 gram of DNA daily
Released in urine as short fragments
Enable use of urine as ideal sample for molecular and genetic testing

Science Backgrounder

We have compiled a literature review to summarize the state of science in the field of circulating nucleic acid detection and the promise their detection holds, particularly in the management of cancer patients.

» download The Detection of Transrenal Nucleic Acids for Patient Management PDF