Things to come?
About 30 months ago, I wrote an editorial discussing the inevitability of drug and diagnostic codevelopment, using as evidence then-recent initiatives by the FDA to define this practice and a variety of companies to explore this marketspace. Two-and-a-half years later, I have been somewhat surprised (and a little chastened) at the lack of significant movement toward this goal despite the noise that has been made (not just by me).
In recent weeks, however, I have taken heart—is this a codependent relationship, or what—at two events that I believe bode well for this effort to truly get underway. The first was a move by General Electric into this field and the second was a simple television commercial.
A couple of weeks ago, GE Global Research and GE Healthcare announced the signing of 3-year collaborative research agreement with Eli Lilly & Co. to discover and develop in vitro diagnostic (IVD) assays that would predict patient response to Lilly's existing and exploratory oncology therapeutics. In effect, GE will leverage its expertise in molecular imaging with samples from Lilly's clinical trials to identify gene and protein signatures.
"The co-development of diagnostics and therapeutics is a major strategy of GE Healthcare's 'Early Health' vision, and our collaboration with Lilly and our expansion into in vitro diagnostics is right in line with this strategy," says Dr. Michael Montalto, GE Global Research's head of molecular imaging and diagnostics. "Through the application of molecular and cell biology to understanding disease, we can provide pharmaceutical companies with more advanced tools to develop more optimal drug therapies for cancer patients."
Oh sure, it sounds like the same rhetoric spilled out by hundreds of company execs, but this is definitely one case where the messenger is as important (or perhaps more important) than the message. If I have learned nothing over the last 40 years or so, I am confident that General Electric does not enter a market hastily, and when they do enter, they come with a mission and a plan. What other company has the technological depth that GE leverages from industry to industry? This could get interesting.
And as I said, the second event was a television commercial I watched the other day while relaxing at home. The unassuming ad merely wanted to let women know that a negative Pap smear was apparently no guarantee of being negative for cervical cancer and that if they really wanted to be sure, they should talk to their physician about getting a test for HPV. The commercial was brought to us from Digene.
What made me sit up was that unlike other ads for diagnostic tests such as blood glucose meters and pregnancy/fertility tests, this ad was pushing a test that a physician would have to order and a hospital or reference lab perform. And unlike a mammogram or prostate exam reminder from a nonprofit health organization, the ad was produced by a company that manufactures the test.
IVD has taken its first tentative steps into the DTC advertising age.
If successful, this little ad could begin the ball rolling for an existing industry that has largely focused its attention on clinical lab technologists and family physicians. And if that takes root, there will be added impetus to get more IVD systems to market. A solid tie-in with a pharmaceutical industry looking to get existing drugs safely to the patients who will most benefit from them (and also not suffer debilitating side effects) will only add monetary fuel to this fire.
But then, I've been down this road before, only to have the diagnostics industry tell me it will be different next time. I guess I'm hopeless.