Thanks, Rudy. Yup, the Xytronyx release came out at just about the same time that we were digging through the EPR, and it seems, to me, to lend credibility to the CIST approach. Note that the assay is approved for detection of "periodontitis, a severe form
of periodontal disease". I "first blush" interpret this to mean that FDA might actually recognize a need for an assay that detects disease at an earlier stage. If you can catch pronounced inflammation at an early stage rather than wait for necrotic lesions, I'd consider it a positive. Furthermore, if the link between the presence of a given bacterial species in periodontal disease is convincingly made with atherosclerosis and/or other systemic diseases, then cost-benefit issues could transform the dentist's office into a haven for disease intervention.
We need to get some diagnostic-type investors interested in this thread. I am not particularly familiar with the regulatory hoops that CIST will be asked to jump through.
I am encouraged by the Xytronyx approval. It indicates that FDA is far advanced on the learning curve that CIST will be traveling (the EPR specifically mentions the possibility of a 510(k) application to the FDA, and the Xytronyx assay could pave this relatively simple route). This could only be a plus for any assay that has competitive advantage. Further, note that Xytronyx has partners for europe and asia. This may provide further incentive for R&D Systems (Techne) to support CIST efforts.
I can't find details of the CIST/Techne agreement, other than Techne (R&D Systems) has "exclusive co-marketing rights". This _could_ mean that CIST retains rights to license the assay for europe and asia. :-)
Another event to watch for..... to my knowledge, the Genzyme agreement expires in 7/98. GENZ will need to obtain IL-1 and kits beyond this date. We should therefore get an indication, in a year if not sooner, of the strength/scope of the PeproTech license.
I still feel that GENZ would be crazy not to consider the fit. And, if there is any viability at all to the periodontal assay, Techne will of course be interested.
Rick |
