Some Interesting Insights into Companion Diagnostics

I have posted a number of previous notes about companion diagnostics (see, as one example, the following: Companion Diagnostics Gaining Ground, But Slowly). Now comes an interesting article that describes in detail about the partnership between a diagnostics company and a pharmaceutical in the future development of such a companion lab test. Below is an excerpt from the article with boldface emphasis mine:

The area of companion diagnostics - ideally defined as a diagnostic developed in tandem with a drug to screen patients for clinical studies and then be commercialized alongside the drug for diagnostic and treatment purposes - has been getting more attention since last year's approval of Selzentry (maraviroc) from New York-based Pfizer. That drug, designed specifically to target HIV patients who test positive for the CCR5 receptor, was developed with the help of Trofile, an HIV co-receptor tropism assay, from Monogram Biosciences. The companies began working together in 2002, and Pfizer used the assay to determine which patients would most likely to respond to treatment for enrollment in clinical studies. In 2006, South San Francisco-based Monogram licensed to Pfizer global rights to Trofile. In that case, "Pfizer came to Monogram," [an analyst] said. "They were developing an entry inhibitor for CCR5 and wanted to select patients appropriately for the trial." And that's the way it likely will have to work between pharma and diagnostics firms in the future, with pharma responsible for driving the development. "For diagnostics firms, it's difficult for them to develop a test without seeing the drug on the other side," [he] said. "It's tough for them to fund that innovation. You wouldn't have seen Monogram developing Trofile on its own, hoping that somebody comes out with a CCR5 therapy."

Here's another quote from the same article:

But [the analyst also] said one of the biggest hurdles is convincing pharmaceutical firms to jump on board the diagnostic train, mostly because pharma has been reluctant to move away from their blockbuster-drug approaches, selling a single pill that can reach a broad market. "Drug companies can be somewhat cautious that having a companion diagnostic might limit the drug's label," .... So "pharma and diagnostics firms aren't really on the same page yet."

All of this makes perfect sense. Big Pharma has been cautious about the wide availability of companion diagnostics in the past because of the belief that such lab testing may constrain the sale of a particular drug. However, as the goal of developing blockbuster drugs begins to fade, Big Pharma now finds it useful to approach diagnostics companies to develop a companion test in parallel with the drug development and clinical trials in order to select the most appropriate subjects for clinical trials and also patients downstream. As I composed this note, I could not help thinking about my previous note (see: Moving Resources from the Therapeutic to the Diagnostic Silo) about using lab tests to monitor therapeutic efficacy. Companion diagnostics provide one of the means by which the right drug can be selected for the right patient.

Comments

[bev M.D.]

If you are a cynic about the pharma industry as I am, this situation seems like a classic Hobsen's choice for them:
they don't want a diagnostic test to see who the drug works for, because it may limit sales, but they need the diagnostic test to pick out people who the drug works for, in order to prove effectiveness to get the drug approved. I find this a delicious irony.