Early Health Model Begins to Merge with Personalized Medicine

In a previous note (see: Five Alternative IVD + Software Business Models), I suggested that there were five major business model being pursued in our industry that involved a linkage between in-vitro diagnostics (IVD) and clinical lab software. Below are the five models that I listed in the note:

• In-vitro diagnostics + medical imaging
• In-vitro diagnostics + pharmaceuticals
• LIS software + upstream IVD instruments
• National reference lab + lab portal software + personalized testing
• Home lab testing + home monitoring software.

Although I did not consider these models to be mutually exclusive, there was enough separation between them at that time that I felt comfortable identifying them as distinct. Companies cited in the first category were GE Medical and Siemens Medical Solutions Diagnostics. I presented Roche as an example of the second category. A recent announcement (see: GE and Lilly Announce Research Collaboration to Co-Develop Molecular In Vitro Diagnostics for Cancer Treatments) suggests that some of the boundaries that I described in the note are now becoming more fuzzy. Below is an excerpt from the article (boldface emphasis mine):

GE Global Research...and GE Healthcare today announced a three-year collaborative research agreement with Eli Lilly ... to discover and develop advanced in vitro diagnostic assays that may predict cancer treatment response to targeted therapies. In addition to Lilly’s existing chemotherapy agents, Lilly is developing targeted cancer therapeutics, which are now in both early and late stage clinical development. GE is developing advanced multiplexed tissue-based assays and image analysis tools that can measure multiple biological pathways. The goal of this collaboration is to discover key protein and gene signatures that will predict the likelihood that a medication will be effective in treating certain cancers. Once identified the signatures can then be used to pre-select patients who are good candidates for the targeted therapy....Through the use of molecular diagnostic tools that can discover key protein or gene signatures, pharmaceutical companies can begin to use that information to determine which patients are most likely to respond to a particular medication based on their particular genetic makeup. The agreement between GE and Lilly will provide GE with access to clinical tissue samples from unidentified patients enrolled in Lilly’s clinical trials. In turn, Lilly will have access to GE’s advanced technologies in automated tissue-based image analysis and molecular reagents. These tools can be used during drug development to aid Lilly in evaluating the effectiveness of their drug candidates and potentially select patients for future trials.

I would make the following observations and draw the following conclusions based on this important emerging news:

• I like the reference to targeted therapies in the article. It's closely related to the term personalized medicine but I think has more punch and will resonate more with both physicians and consumers.
• Note the reference in the article to multiplexed tissue-based assays. I have posted multiple previous notes about tissue biomarkers and hyperspectral tissue analysis. This is what Dr. Mike Feldman refers to as "slow cytometry" as opposed to "flow cytometry." Multiplexing enables the simultaneous identification and quantification of multiple tissue biomarkers. Recall that molecular imaging is moving in a direction whereby more information about a tumor than its location and size can be obtained such as its diagnosis. Couple this imaging modality with fine-needle aspiration of a tumor at the same time and you have an opportunity to determine, for example, the aggressiveness of the lesion and its propensity to metastasize.
• Finally, note the reference to GE's new access to clinical tissue samples in Lilly's clinical trials. Look for advanced imaging technologies to be more closely integrated into clinical trials on the basis of partnerships such as this one. Such agreements will also provide the means by which GE will place advanced imaging equipment into academic medical centers as part of its early health model campaign. Such integration of imaging into drug trials will make the approval of research protocols more complicated but, in the long run, will link new imaging modalities to the clinical trials. Win-win all the way around.