Some huge takeaways from the lengthy, but informative article:
1)There is a growing imperative, both clinical and budgetary, to accompany therapies with diagnostic tools of increasing sensitivity and specificity to better identify the patients in the relevant disease subtype and most likely benefit from therapy. The marketing model forseen for most specialists in the future will include a companioin diagnostic as a key element. (Hello. Recaf will be that companion diagnostic they are referring to).
2)They talk about current markers and any having 90% sensitivity and 90% specificity or higher are extremely rare and there is a need to improve the effectiveness of these diagnostics. (Wow. Isn't that exactly what recaf has recently been proven to do by Dr Moro at the 2009 ISOBM?......elimination of all false positives to the most widely used current markers and boost results above 90%.......we have what medicine has been crying for. That is why we will be used as a companion test and that is how management will likely refer to recaf).
3)Dr Moro did you know government funds are being committed for research projects for personalized medicine? Maybe apply for a grant before you dilute shareholders.
4)Inverness acquired Matria Healthcare in 2008 as part of a disease management division and we certainly fit in under disease mangement when you consider those that have been stricken with cancer will forever need to managed by checking their blood levels for recaf.
5)Originally Beckman-Coulter was to buy Biosite, but Biosite withdrew from the deal and was acquired by Inverness. ( I believe the Biosite division is doing the heavy lifting on recaf for Inverness). We could have been partnered with Beckman-Coulter and if I was management I would present this case to Beckman to see if they would like the last semi-exclusive license for recaf. Beckman bought the diagnostic's system of Olympus this year and they do the ultrahigh throughput diagnostics. Hmmm? The plot thickens.
6)This year Inverness bought Acon.......they are into lateral flow immunoassays and are huge outside the US. Nice!!!
7)Others: Siemens is in discussions now with Labcorp......possibility for us. Bayer is focusing more on diabetes so count them out, don't know much about Bio-Rad so who knows?
8)The FDA is encouraging greater use of biomarkers and diagnostics to accompany drug development and prescribing.
9)The pathway to US approval of new biomarkers is thru a 510k and the EMEA's biomarker testing is far less stringent.
Nice article.
