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Exclusive Life Science Feature N o industry trend is more promising, and yet more conflicted, than personalized medicine (PM). In its ratio- nale, PM is almost logically invincible; who can argue with matching individual patients with medicines to which they are most likely to respond? But in prac- tice, despite citable though qualified successes, the rationale often breaks down. Expensive and complicated tests, gaps in companion-diagnostics regula- tion, meandering business models, tiny patient segments, and record-high prices as the apparent trade-off for volume sales all tarnish the beauty of PM logic. So, it is natural to be a bit skepti- cal when a new voice comes on the scene to proclaim another technologi- cal revolution in the PM sphere. That voice belongs to Dr. Anita Goel, CEO of Nanobiosym, who combines her busi- ness message with a grand vision of global medicine transformed by what she calls "nanodiagnostics." Nanodiagnostics is an accurate term in Goel's case, because her company's Gene-RADAR chip, developed so far pri- marily through U.S. defense and other federal grants, probes DNA molecules at the nanometer scale. "What we are doing in our Gene-RADAR is using a very high degree of precision control with nano-scaled schemes to control DNA molecules, and the nano motors that read and write information into the mol- ecules enable controlling them on very precise scales to achieve faster, better, cheaper readouts of the DNA." But the "nano" label does not apply to all single-unit, nonlaboratory diag- nostic tools now in development. Thus, here we use the more widely applicable term "rapid mobile diagnostics" (RMDx) to encompass all the micro, milli, and other portable-scale Dx technologies. (Another, less-specific term in general use is "point-of-care" diagnostics.) And, as a new technological space containing all the alternatives, the most practical and immediate application for RMDx may be in clinical trials. Beyond portability and speed, many RMDx technologies also claim higher accuracy than current lab-based, ELISA (enzyme-linked immunosorbent assay) tests. Some of the new technologies, like Gene-RADAR, vie to replace the old light-sensing, antibody-targeted assays with much more accurate but ephemeral DNA detection, thereby also dethroning PCR (polymerase chain reaction). Other RMDx devices measure non-DNA indica- tors of drug response and disease status, such as oxygen molecules. Microfluidics is a popular platform, but new modes, such as MRI or LCD technology, are always popping up. In an ideal world for all RMDx developers, their technologies would spread across the entire clinical spectrum, from research to mainstream treatment. Goel and others in the RMDx space maintain the technology could speed up trials and regulatory reviews by quickly selecting ideal patients and expediting the collection and analysis of patient response data. For regulators, the review process would operate in a higher gear thanks to the higher-quality data and higher benefit-risk ratios as predicted by the patient selection. "You find patients in a target population before you enroll them in a clinical trial, and you accel- erate the drug development process, decreasing the cost and time in getting FDA approval, because you've focused your patient population in such a way, based on their biomarkers, that they will be more likely to show increased efficacy and decreased toxicity," says Goel. A WORLD OF PLAYERS In a nutshell, Nanobiosym's initiative spans all the possible fields of play in the RMDx game, from research to fight- ing the world's worst epidemics. But its Gene-RADAR technology has plenty of competition from other companies, platforms, products, and applications. In addition to an untold number of small, entrepreneurial companies, large med- ical-device makers like Roche, Abbott, and Siemens are developing RMDx. To gather a core sample of the lesser-known startups, we spoke with several other companies for this report — Rheonix, T2 Biosystems, and SuperNova Diagnostics — each with its own unique platform. Although every new technology may have its own list of initial disease targets, most aim for maximum flexibility in cus- tomization, so it is likely many of them will overlap in promise and in practice. Some developers share Goel's vision that RMDx use in the developing world will lead to its adoption in the devel- oped world; others do not. But essen- tially all players agree that commercial competition in the major markets will ultimately shrink the field. Clinical trials logically present the first large competitive space for RMDx tech- nologies. Diagnostics in general already have wide use in clinical development; a simple search for "diagnostic test AND "There are two big trends in medicine. One is the personalization of medicine, and the second is the mobilization of medicine." Dr. Anita Goel, CEO, Nanobiosym September 2012 LifeScienceLeader.com 39