26 Dec 2012, Mr Cameron Reynolds , BioSpectrum
The diagnostics market is growing rapidly as patients demand earlier diagnosis of diseases through the use of less invasive diagnostic techniques. There is also greater awareness and demand of genetics-based diagnostics to provide patients with a personalized approach-to-care. Beyond genomic analysis, we believe that epigenomics will continue to grow rapidly, proving to be as important, if not more, as compared to simple genetic analysis.
During the late 2012, we launched our NuQ range of epigenetics immunoassays for the research community. The kits are based on our proprietary platform Nucleosomics, a tool for epigenetic profiling using serum, plasma or other biofluids. The kits, which are based on a simple ELISA, measure and analyze nucleosome structures, with kits available to detect histone variants and post-translational modifications as well as DNA modifications in intact nucleosomes; as well as nucleosome-protein adduct assays for cell free nucleosomes. In the year 2013, we aim to build a robust customer base within the research community for these kits.
Concurrently, we will continue to validate our tests for a range of cancers through multiple clinical trials with a view to making our first CE application in 2013, and beginning the FDA approval process. Initially we are focusing on four major cancers: breast, lung, pancreatic and colorectal, although we are also carrying out a larger study into the 20 most prevalent cancers.
Despite some negativity in Europe over the European Community's financial future, we have had an excellent experience working with the Walloon Region of Belgium, who furnished us with a generous grant. The local scientists that we have employed are entrepreneurial and skillful, and we have made excellent contacts with local companies of all sizes at conferences run by regional bodies like BioWin.
As always, the American market has been incredibly supportive both before and since our listing in 2010, and we look forward to establishing a permanent foothold there from 2013.
The main challenge for a small company is driving innovation and attracting talent, while securing the financial resources to implement its business plan. The launch in late 2012 of our research products will provide revenue to fund our clinical trials in 2013. The other main issue for us in 2012 has been accessing quality patient samples for our clinical trials. Given the large amount of work done, and the success of our results in 2012, we are gaining access to much larger numbers of patient samples for our trials.