We’re supposedly in the dawn of personalized medicine, where advances in molecular biology are providing doctors the opportunity to optimize each patient’s care. As a Technology Marketing Specialist in Children’s Hospital Boston’s Technology and Innovation Development Office, I should be enjoying the view. But I’m still waiting: how will it happen, when will it happen?
I look around at the hospital and I see our discovery operations humming. We’re generating and characterizing new biomarkers as fast as vendors are releasing applications for the iPhone. We have biomarkers for appendicitis and for an amorphous condition called chronic pelvic pain, as well as an early indicator of prostate cancer. These are all things that consumers would want, and as a consumer, I wonder, “What’s the holdup?”
It seems to me some company would have figured out by now that consumers like me would be willing to pay for a urine dipstick to check their vitamin D levels, or gauge their diabetes risk, or any number of things, with biomarkers. As a professional, I wonder, who should we take these markers to? Pharmaceutical companies? Diagnostic companies? Google? How do you get them to the consumer in a way that makes money? What is the business model?
Right now, the hospital is a bit like a primordial soup. We have all the ingredients: the biomarkers; patients in whom we can validate them; sophisticated platforms to measure them; and informatics to understand what they mean. We are just waiting to see that spark of life: a nifty product, tied up with a bow, that industry can take to consumers or their doctors.
With healthcare reform, barriers may increase. We can expect more and more payors to raise the bar and decline to reimburse creative new diagnostic assays. Instead, they may prefer the “tried and true” 510(k) approval route which requires years of diligence and widespread acceptance by clinicians before new biomarkers are used in clinical practice.
But consumers may not be so hesitant. Just as diabetics test their blood sugar on a daily basis, a patient with fibromyalgia or the parents of an autistic child might want to check some recently discovered biomarkers to help monitor the effects of different lifestyle changes. If we can get past the barriers, we might see diagnostics taking a more active, intimate role in patients’ lives.
The platforms may not yet be small and portable. They may need some work to improve their sensitivity and specificity. The data interpretation may not be perfect. Guidance from the FDA regarding new biomarkers is in flux. But, surely, someone can figure out to sell biomarker information to consumers in a way adds value to their lives. Can’t they? I’ll be watching.