Therefore, one strategy the Company is pursuing once clinical trials are established is to seek IND for a new theranostic drug. An alternate, but not mutually exclusive, strategy is to separately develop the blood–based diagnostic biomarker in parallel with the new drug/biologic. This is an important, if nuanced, difference since the new category of theranostics are tied to widely available and standardized chemical or immunologic tests. Our platform of blood-based diagnostic biomarkers for concussion represents a new diagnostic approach utilizing hybrid nucleic acid, protein and spinning disk or microarray technology. This hybrid approach, since it will involve more than one analyte, would fall under the heading of In Vitro Diagnostic Multi-Analyte Assays (IVDMIAs). We anticipate that this will result in an “analyte specific reagent” (ASR) as used within the concussion situation as described above and for other neurologic disorders as well. As such, in its proprietary approach to this problem the Company is developing new specialized reagents, equipment and expertise. Within this context, the Company may seek direct FDA approval for a “test kit” and/or device. The FDA may grant approval based on different criteria for such an ASR compared to those for standardized tests. We may seek to partner and/or joint venture with diagnostic developers or device manufacturer. Although it takes longer then seeking an ASR approval from the FDA we might also seek approval while in Phase 2 or Phase 3 clinical trials. One advantage is a simpler reimbursement process, however, there may be other problems we might encounter such as test quality and comparison amongst different manufacturers. This might involve partnering with more than one kit manufacturer but as another advantage of providing a revenue stream for the therapeutic development portfolio.
This strategy is not without challenges especially from the marketing perspective. We seek to develop a “gold standard” diagnostic kit for concussion but are mindful of the possibility that this will detract both resources and energy from the therapeutic portfolio. We are aware that new theranostics can actually impact sales negatively of drugs, which they are connected and, clearly, this would not be ideal. However, such tests have been developed historically not by the biotech company but by academic researchers, by third-party payers and even by large Pharma, who might be viewed as competitors for the therapeutic. At this point in time, it is the pHLOGISTIX strategy to develop the companion diagnostic in parallel with the therapeutic portfolio.
