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Get Ready For Big Action In Cancer Diagnostics
Currently, investors who are following the cancer diagnostics space are watching the two battling colon cancer companies ? Exact Sciences and Epigenomics ? ahead of important FDA advisory committee meetings for colorectal cancer (CRC) diagnostic tests. At these meetings, a panel of physicians will review and thoroughly discuss the application for approval of a new medical product. Voting members will then vote on whether or not they agree that the FDA should approve the product.
By Bio Insights
Mar 25, 2014 12:36:28 PM PDT
-Epigenomics AG is about to have an FDA panel review of the PMA for colorectal cancer screening test Epi proColon on March 26th
-Exact Sciences will have an FDA panel review of the PMA for ColoGuard shortly after, on March 27th
-VolitionRx reported new results for NuQ, showing accurate detection of prostate and colon cancer
Currently, investors who are following the cancer diagnostics space are watching the two battling colon cancer companies ? Exact Sciences and Epigenomics ? ahead of important FDA advisory committee meetings for colorectal cancer (CRC) diagnostic tests. At these meetings, a panel of physicians will review and thoroughly discuss the application for approval of a new medical product. Voting members will then vote on whether or not they agree that the FDA should approve the product.
Generally speaking, these advisory committee meetings are just as meaningful as FDA approvals when they are skewed either towards the positive or negative side. It is possible that the stock market will adjust for a positive or negative FDA decision just on the vote provided by the advisory committee meeting.
Exact Sciences and Cologuard
Cologuard has an advisory committee meeting scheduled for March 27th, 2014. Based on the Phase III DeeP-C trial, the market seems to think that the data are good enough to warrant approval.
Earlier this month, we saw a great peer reviewed article on Cologuard in the DeeP-C trial published in the New England Journal of Medicine. In it, we saw a confirmation of the 92% CRC detection rate, which was superior to the 74% detection rate seen for fecal immunochemical tests in that trial. One of the main reasons that this trial drew so much attention was due to the large patient population (10,000 total), which added significant weight to the results. I also think that it is the sheer size of the trial, and the positive results that have allowed Exact Sciences to achieve a $1 billion valuation.
Exact Sciences is currently not generating revenue according to the recent annual report, but it is holding around $13 million in cash and $120 million in short term investments. Based on the company?s cash burn rate of $47 million per annum, EXAS has over two years to generate significant revenues from Cologuard to offset operating losses. The success of this company is heavily dependent on Cologuard.
Epigenomics and Epi proColon
Less known in the US than Cologuard is the Epi proColon test, which is the colorectal cancer diagnostic being developed by the German company Epigenomics AG (ECX). Epi proColon has an FDA advisory committee meeting scheduled for March 26th 2014.
Epigenomics will be introducing an improved test for Septin 9, which is currently one of the best biomarkers for CRC other than hemoglobin. Although the data for Epi proColon appear to be worse than data for Cologuard, it is worth consider that this is a blood-based test that will not have as many issues with patient compliance. I also believe that the data produced by Epigenomics are also more ambiguous, and that we may see better rates in a redesigned trial.
According to their recent annual report, Epigenomics CEO Thomas Taapken showed great enthusiasm over what he called the ?primary value driver? of the company ? Epi proColon.
The company?s financial position was also improved after raising a total of 12.5 million (EUR) in 2013. The should about about $10 million EUR is cash at this point, which should give the company about one and a half years based on 6.5 million EUR cash burn for fiscal year 2013. Epi proColon has also been approved in a number of countries outside of the US, which will produce revenue to offset cash burn from US operations.
VolitionRx and NuQ
VolitionRx (VNRX) is the youngest of the three potential upcoming CRC diagnostic companies, and has a very unique approach to CRC detection and screening that should allow this company to market an equally effective blood-based test for less money than Cologuard or even fecal immunochemical tests. NuQ is in an earlier stage in development, although it is valued significantly lower than Cologuard and Epi proColon.
VolitionRx is also working on a blood test, although it will be using epigenetic biomarkers that have never been used before by cancer diagnostics. These biomarkers, which would be found on nucleosomes circulating in the patient?s blood, can also be unique to specific types of cancer. For instance, as mentioned by the company in a recent release, H3K9(Me)3 is a biomarker that can be used for CRC but not prostate cancer.
After raising about $3 million in a private placement, VolitionRx is in a more comfortable position with around $3.5 million in cash and a quarterly burn of about $926,000. The company should have enough to fund operations going into 2015, and before that we?re expecting more robust data from the NuQ development programs.
Importance of CRC Screening
The topic of CRC screening has been beaten to death in the oncology community, but public awareness of the benefits of CRC screening can definitely be improved. Because of the failure to detect CRC in the early stages, it is the second most deadly cancer in the United States,
Currently, the fecal immunochemical test (FIT) dominates CRC screening. This is a pretty simple lab test that requires a stool sample, and tells the physician whether or not there is blood in the stool. But despite its impressive~70-90% specificity and sensitivity for CRC, it is terrible for precancer detection. Polyps, which can sometimes develop into cancers, are usually worth finding and removing.
What Should We Expect?
Wednesday and Thursday will certainly be interesting for anyone invested in the colorectal and cancer diagnostic space, because it will give us a lot of insight into the way that physicians associated with the FDA view cancer screening products.
Because of the unmet need in this space and the lackluster performance of existing diagnostics, I am expecting favorable votes to come through for both CRC screening products. If this is the case, FDA approval is much more likely, and the market will account for higher likelihood of success for these new CRC screening products. I think this would lead to bullishness towards EXAS, ECX, and VNRX and perhaps some bearishness towards existing diagnostics vendors due to the current stranglehold that the fecal immunochemical test has on the CRC screening market.
At the same time, there are definitely some risks to consider. Not only are the three stocks I mentioned here volatile, but they are dependent upon their success in the CRC screening space. This is especially true for Exact Sciences, which has breached a $1 billion valuation based on the implied success of one product in the US market.
Even if the FDA eventually approves the PMAs for Cologuard and Epi proColon later this year, there is no guarantee that these screening tests will be successful once they hit the market. Many physicians will have to replace fecal immunochemical tests to justify the current valuation of Epigenomics, and especially Exact Sciences. Later on, this will also be applicable to NuQ.
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