SAN JOSE, Calif. The promise of personalized health care based on DNA analysis has yet to be realized due to the technical and market complexities establishing this emerging field. A handful of products use DNA and protein analysis to tailor use of prescription drugs, but to date they have not gained much traction.
"It's not a gold rush, but I'm convinced we are at the beginning of a new era in personal health care," said Mike Samoszuk, chief medical officer of Roche Diagnostics, speaking at the Biomed Device event here last week.
Roche has developed one microarray-based test, the AmpliChip, to determine how individual patients will metabolize a variety of drugs including antidepressants. However, so far at least three major health care providers have decided not to reimburse for use of AmpliChip, he said.
Part of the problem is Roche has not made the uses and benefits of AmpliChip clear enough, Samoszuk said. "You have got to tell a simple, clear story that payers, patients and doctors can understand," he said.
Nevertheless, Roche has been expanding its group of at least five different diagnostic divisions in the race to personal health products based on biomarkers, biological parameters that define a disease process or a patient's reaction to a drug treatment.
"Roche is engaged in intense work to develop biomarkers for all our drugs," he said. "Biomarkers are incredibly complex--there are literally thousands of possible biomarkers for any disease," he added.
Samoszuk's comments were among many at the event indicating both the promise and the pitfalls ahead for the medial electronics community. The design and regulation of so-called convergent devices that blend a device with a drug was another hot topic for a wide range of speakers including executives from implant-maker Medtronic and a handful of practices physicians.
The recently installed chief scientist of the Food and Drug Administration was also on hand to talk about his plan to bolster the agency's science prowess. Frank Torti, who joined the FDA in May, said the group's recent hiring of 1,300 new staff members was just a beginning of its plan to keep pace with increasing globalization and technological change in medical devices.
On the show floor, many small design firms pitched for what they see as a growing business in outsourced medical designs at a time when new products are increasingly geared to consumers using health devices a home. Thus those devices are becoming more responsive to the needs for fast time to market and good industrial design, they said.
Also of note on the show floor were vendors of two USB microscopes. Peter White, sales and marketing director of Bodelin Technologies (Seattle), demonstrates the USB-based ProScope HR (see below). It and a competing device--the Dino-Lite from BigC (Torrance, Calif.)--are seeing increasing use for electronics inspection and a host of other uses, especially now that they support live video microscopy imaging over the Web.