Trovagene: Built on experience and starting to move Print E-mail
By Staff and Wire Reports   
FDA CalendarShares of  Trovagene (TROV.PK) rose 11.25% after we first told our premium subscribers about this intriguing diagnostics play on Thursday.

The founder of Gen-Probe and the former CEO of Sequenom have formed a new venture with Inhibitex (INHX) player Gabriele Cerrone in diagnostics. The firm, Trovagene, is currently listed as a fully reporting pink-sheet company that is about to be uplisted (according to our own sources) to the OTCBB in relative short order. The stock has doubled since we first heard about it a couple of weeks ago and there is still considerable upside.

Here is the story:

In 1984, Dr. Thomas Adams founded Gen-Probe (GPRO), now a leading molecular diagnostic products and services company. He went on to serve in senior management positions with several leading medical device and diagnostic companies, including IRIS International (IRIS), where he serves in the capacity of Chief Technology Officer and a director of the company. Eleven years after his tenure as CEO of Gen-Probe, Dr. Adams has joined yet another molecular diagnostics firm - Trovagene (TROV.PK) - as Chairman of the board.

Gabriele Cerrone, a principal investor and founder of Trovagene, was also the founder and Chairman of FermaVir Pharmaceuticals, which was bought out by Inhibitex (INHX) in 2007. He was appointed a Director of the acquiring company, which in turn was acquired by Bristol-Myers Squibb (BMY) earlier this year. Cerrone was one of the largest shareholders in Inhibitex when Bristol-Myers Squibb offered $2.5 Billion to acquire what the pharmaceutical giant called 'an innovative medicine for treating Hepatitis C'. According to a recent disclosure in a SC 13G filing Cerrone now serves as a Director of Trovagen, where he holds an 11.4% vested interest.

Trovagene, which believes it has a next-generation technology to screen for diseases using a patient's urine sample, is developing safe, non-invasive, simple, and, importantly, cost-effective methods for screening infectious diseases, detecting and monitoring tumors, and tests for other clinical utilities. The company's proprietary technology rests on the detection of trans-renal nucleic acids in urine, or "DNA in urine". As the following diagram shows, cell-free fragments of DNA that cross the kidney barrier can be detected in urine. These fragments are then used as genetic markers of disease.


Trovagene differentiates itself from competitors like Gen-Probe (GPRO), Sequenom (SQNM) and Transgenomic (TBIO.OB) by providing a non-invasive, safe, and inexpensive platform for disease detection that holds the potential to replace complex and less robust earlier technologies based on circulating cells and nucleic acids in blood. Inevitably, tissue and blood samples that are used to test for disease require administration by a physician, whereas a urine sample can be collected by patients themselves. Another interesting advantage to Trovagene's platform is its accuracy in detecting markers of disease. Trovagene conducted a trial of their HPV urine-based test to identify women at risk for developing cervical cancer. The results were as follows:

"The study, conducted in India, enrolled 320 patients. In this study, 31 out of 38 cervical swab samples that were initially classified as “negative” were subsequently determined to be positive by PCR followed by DNA sequencing of the urine using our urine-based platform.  Additionally, 24 out of 34 cervical swab samples initially classified as “positive” were determined to be negative based on DNA sequencing of the urine. Our urine-based test only had 10 false negatives and 7 false positives, an impressive 93% sensitivity and 96% specificity. As a result we believe that the sensitivity and specificity of our urine-based test is at least similar to and potentially better than the currently used cervical-cell-based tests."

What these results demonstrate is that Trovagene can answer the call for an efficacious technology that will allow for earlier detection of disease - a call that the company estimates will be worth at least $20 Billion worldwide, by 2013.  

Interestingly, Dr. Antonius Schuh, who served as Sequenom's Chief Executive from 2000 to 2005, was appointed CEO of Trovagene late last year. He served as CEO of Arcturus Biosciences in 2005; the company was acquired by Molecular Devices a year later. In 2006 Dr. Schuh founded AviaraDx, a molecular diagnostic innovator in oncology. AviaraDx was sold to bioMerieux in 2008. Schuh is also currently a Director of Transgenomic.
The convergence of highly-experienced and respected leaders in biotechnology - specifically the diagnostics industry - is unprecedented in a company with an emerging technology. Dr. Adams, Dr. Schuh, and Mr. Cerrone comprise a talented group of entrepreneurs who have successfully built and sold technologies in the very same space where Trovagene will look to make a name for itself. Importantly, serving in the capacity of Directors of other biotechnology companies allows TrovaGene's leaders to keep a pulse on disruptive technologies that could change industries going forward.

Trovagene's patent-protected, new-generation molecular diagnostics platform could transform the molecular in-vitro diagnostics industry as it's known today.

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