Trovagene's Potential: A Physician's Perspective I’m a physician with a long time interest in molecular diagnostics. I work closely with clinicians in the fields of oncology, radiology and many other medical/surgical subspecialties. I have been closely following the progress Trovagene has made through 2013 and 2014. Here’s my take: Molecular diagnostics is still only in its infancy but will transform the field of medicine. This is a critical component of personalized medicine, particularly in the field of oncology where there is rapid development of targeted therapies which work at the level of the driver mutation of a patient’s particular cancer. The molecular information needed to select the appropriate therapy is often obtained via tissue biopsy when possible. However, many tumors are in difficult to biopsy locations or there is a high risk of hemorrhage in the case of vascular tumors. Noninvasive means to obtain information on the driver mutation is needed in these cases, which can be obtained via cell free DNA in blood or urine. However the real challenge today lies in closely monitoring treatment response and mutational status after a treatment is initiated. Urine would serve as a far more practical and less expensive analyte than blood for numerous reasons. First, frequent sampling is often required which is much easier with urine compared with blood. Second, although the sensitivity of NGS technology is superb these days, the limiting factor in many cases is the volume of the analyte. Large samples of urine are easy to collect. Third, urine can be collected at home and shipped to a CLIA lab without the need for a lab tech to draw blood. Fourth, urine is a more stable analyte than blood which becomes important when samples are collected in remote locations then shipped to the lab (think patient access issues in the developing world such as HPV screening). In my opinion, patient cool headed investors who can stomach volatility will be rewarded as the market capitalization of this innovative company grows significantly over time. We’ll touch base again in 2015
Why not just continue to follow these patient’s with imaging alone? After treatment is initiated we often don’t get follow up imaging until 3 months. It’s an every day occurrence to see significant worsening of disease on follow up imaging which obviously indicates that treatment hasn’t been effective. If there were a way to determine treatment response and mutational status in a noninvasive way after only a few weeks of treatment that would be transformational. Sure, some tumors have blood markers which can be followed, but many do not. Plus if a therapy is not working, we need to know the mutational status to help determine the necessary changes in treatment.
Trovagene could potentially hold the key to addressing many of these challenges which is exciting for clinicians and patients alike. Insurance companies and integrated health care systems will benefit tremendously from the ability to noninvasively monitor treatment response and mutational status in near real time. Why? Because if a treatment which costs $20,000 per month isn’t having the desired effect, we can now become aware of this in a matter of weeks instead of months which will save large sums of money for insurers. But it’s the potential for greatly improved patient outcomes that excites me.
If you are an investor, what will matter most in the short term are meaningful clinical collaborations. This is a truly novel and exciting approach to cancer monitoring, but broad adoption is only possible if industry leaders gain hands on experience with these assays. As clinical validation studies progress, the investigators share their enthusiasm with their colleagues which often leads to additional studies for new indications. Over time, familiarity and awareness of this technology grows, as does the clinical body of evidence. This is what eventually leads to broad clinical adoption of novel technologies and subsequent insurer reimbursem*nt.
It will take time for the clinical validation studies to report out but thus far I am very impressed with what I have seen. These are still early days for Trovagene and molecular diagnostics as a whole, but I believe Trovagene is one of the companies with great potential in this space. Toni Schuh and Mark Erlander are very capable and experienced. They know what it takes to clinically validate this technology, secure insurer reimbursem*nt, and commercialize this novel cancer monitoring platform. Mike Terry has done a superb job of building clinical collaborations and there are more to come. David Moskowitz (IR) has been very busy increasing investor awareness of the Trovagene story as evidenced by the sharp increase in trading volume. He has also been effective at clearly communicating the companies strategy and potential to analysts who, as a result, are very optimistic but also realistic about the time it takes for broad clinical adoption of new medical technologies.
