Trovagene may have solved the elusive Liquid Biopsy Print E-mail
By A.J. Deniken, Contributor   
Tuesday, 17 July 2012 12:55
icon_closerlookFor several decades, researches have been developing technology that will pinpoint cancer cells or DNA fragments (nucleic acids) in blood to detect cancer in patients.  Several factors have held this technology back; one the most difficult hurdles is the need for large amount of blood samples.

It is not feasible to take large blood samples from patients multiple time in a year, and it is very expensive to find the one cell or gene fragment which is targeted.  Trovagene, Inc. (NASDAQ:TROV) has found what they believe is a solution.  Trovagene’s technology was developed to commercialize the discovery that post in-vitro cellular death, nucleic acids from these deceased cells circulate in the blood and then pass through the kidneys and are expelled from the body in urine.  These are called Transrenal Nucleic Acids (TNA).  Trovagene’s technology detects and identifies the TNA’s to determine if a person has certain diseases.  Trovagene’s management believes they can develop urine based molecular diagnostic tests for multiple markets, including Cancer Tumor Markers, Viral, Bacterial and Parasitic Pathogens, Fetal DNA Markers and Transplant Markers. 

Trovagene plans on focusing on the cancer market while seeking partners to develop the other markets where the Company believes their technology will be effective.  Trovagene currently has assays running in their labs evaluating the K-RAS gene mutation, which is highly prevalent in pancreatic cancer.  Initial comparisons show that urine based testing for the K-RAS mutation is more sensitive than current blood based tests.  Trovagene takes the urine samples and isolates the Transrenal DNA in the urine, using simple proprietary methods, followed by detection of DNA fragments bearing specific genetic markets.  The detection of the DNA fragments is done by readily available analytical equipment such as Digital PCR Assays.  The cost of DNA sequencing equipment and testing has come down to the point where tests cost $10 to $20 dollars to conduct, this is in contrast to the cost of about $1,500 just three years ago.  These technology and cost advances, along with the ability to use urine samples, in several high volume markets, make Trovagene’s technology a potential market changer. 

Trovagene foresees their technology platform utilized for inexpensive, accurate testing for early detection of cancer in high-risk patients.  Also, the Company expects to test for cancer in post-operative patients to ensure successful surgeries and follow-up treatments.  Due to the fact that the tests are urine based there is no limitations of volume sample availability, as with blood, or frequency of testing. 

In the cancer research community, one of the most prevalent discussions is gene mutation detection in cancer patients.  Trovagene is positioned to become a leader in this area.   Trovagene is currently planning to start assay development studies on the 20 most frequent cancers, as well as validate the performance of the K-RAS assay.  These studies should be completed in 2013. 

Trovagene has spent this year building out their management team, scientific advisory board, improving their share structure, raising $10 million and looking for partners for their technology outside of cancer.  On June 7th, Trovagene announced they were collaborating with Strand Life Science to validate and offer a urine-based HPV screening test in India and South Asia.  The press release stated, ”Strand intends to establish Trovagene's proprietary HPV assay technology in its molecular diagnostic laboratory operations and to perform extended analytical and clinical validation studies in its target markets.  The initial validation will assess the diagnostic accuracy using urine as a specimen for HPV testing in various stages of disease progression, ranging from low-grade erosions to established cervical cancer.  This will be compared to standard cytology and PAP staining as well as a commercially available standard molecular test for the detection of HPV DNA from cervical smears…. A urine test holds the promise to identify individuals free of high-risk HPV in an entirely non-invasive fashion." 

Trovagene has had a productive year, but much of this success has not been reflected in their stock price.  The Company has enough cash to get them into 2014, and they are moving quickly to develop and study addition assays for various cancers.  It is only a matter of time before the Company garners partners for the other remaining markets for their platform.  A look at Sequenom, Inc. (NASDAQ; SQNM), one of the closest comps to Trovagene, reveals a company with a market cap of over $400 million with revenues and income in the trailing twelve months of $57 million and a loss of $85 million respectively, according to Yahoo Finance.  The revenue potential of Trovagene’s platform in the cancer monitoring market alone is strong.  Trovagene believes this market can be greater than $10 billion.  They use the estimate of 18 million cancer patients and survivors by 2020 in the US only, and forecast 2 tests per case per year at $300.  The market for early detection of cancer could be significantly greater in the US.  Trovagene currently has a market cap of around $50 million and enough cash on hand to continue product development.  If Trovagene continues to have developmental success and gets their product to market, a valuation greater than SQNM is not out of the question 3 to 4 years down the road.  At the current valuation investors may be wise to begin accumulation initial positions and ride along with Trovagene’s future success. 

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