J. Craig Venter and colleagues have launched a full frontal assault on direct-to-consumer genetic firms, by publishing an opinion piece in Nature that calls into question the value of DTC genetic tests. By conducting a small experiment that compared tests from two competing companies (23andMe of Mountain View, CA, and Navigenics of Foster City, CA), the team showed the presence of some serious inconsistencies between the results. Moreover, Venter’s group questions how much practical and actionable information one could gain from these tests, and suggests stronger, more effective reporting standards for this newly emerging direct-to-consumer technology.
Opinion in Nature: An agenda for personalized medicine…
Editorial in Nature: Putting DNA to the test

Researchers from the University of Michigan and University of Minnesota successfully used gene transfer therapy to improve the function of cardiomyopathic hearts. The belief is that this kind of “closed heart surgery” may one day prove effective as a clinical therapy.

To make this advance, Herron [Todd J. Herron, Ph.D., research assistant professor of molecular and integrative physiology at the University of Michigan --ed.] and colleagues treated heart muscle cells from the failing hearts of rabbits and humans with a virus (adenovirus) modified to carry a gene which produces a protein that enables heart cells to contract normally (fast molecular motor) or a gene that becomes active in failing hearts, which is believed to be part of the body’s way of coping with its perilous situation (slow molecular motor). Heart cells treated with the gene to express the fast molecular motor contracted better, while those treated with the gene to express the slow molecular motor were unaffected.
"Helping hearts heal themselves, rather than prescribing yet another drug to sustain a failing organ, would be a major advance for doctors and patients alike," said Gerald Weissmann, M.D., editor-in-chief of the FASEB Journal. "Equally important, it shows that gene therapy remains one of the most promising approaches to treating the world’s most common and deadliest diseases."
Current clinical agents and treatments focus on the amount of calcium available for contraction, which can provide short-term cardiac benefits, but are associated with an increased mortality in the long-term. Results from this study show that calcium-independent treatments could have implications for heart diseases associated with depressed heart function, due to the effectiveness of fast molecular motor gene transfer on the improved contractions of human heart muscle cells.

Abstract in FASEB Journal: Ca²⁺-independent positive molecular inotropy for failing rabbit and human cardiac muscle by {alpha}-myosin motor gene transfer
University of Michigan: Scientists jump-start heart cells by gene transfer…

There’s a great deal of speculation about the effect RFID (radio frequency identification) technology has on medical equipment. So the researchers from Georgia Tech, backed by an industry trade group, have setup shop to find out what consequences RFID might have on medgadgets. From implantable devices like pacemakers and deep brain stimulators to clinical equipment like infusion pumps and pulse oxymeters, the goal is to setup a set of protocols to evaluate just about any medical gadget-RFID interaction imaginable.

The test protocol development is being overseen by AIM Global, the international trade association representing automatic identification and mobility technology solution providers, and also includes MET Laboratories, a company that provides testing and certification services for medical devices.
The researchers will test whether radio frequency-emitting devices cause any negative effects on the medical devices, and under what conditions these effects might occur. Testing will also determine whether specific medical devices are particularly susceptible to certain radio frequency identification characteristics and if any corrective actions can be taken to mitigate such susceptibility.
Medical device testing is not new for GTRI, which established its Medical Device Test Center more than 14 years ago. The facility was created to enable manufacturers of implantable cardiac pacemakers and defibrillators to work with providers of electronic article surveillance (EAS) systems, used by retailers, libraries and other establishments to prevent theft and track inventory. The center’s original mission was to help manufacturers improve compatibility between implantable medical devices and EAS systems that radiate electromagnetic energy. In 2006, GTRI expanded its operations and facilities to test new types of security and logistical systems (SLS), including RFID.
To test the effects of RFID systems on medical devices, the researchers simulate real-world conditions by placing a medical device in a tank of saline solution that simulates the electrical characteristics of body tissue and fluid. The medical device is then exposed to different RFID technologies. Several tests are performed with the device placed in different orientations to represent how people typically interact with the emissions.
“We think the testing procedure for RFID systems will be similar to the EAS system procedure, but there are a few more challenges with the RFID systems because a person doesn’t always pass through a portal,” noted Bennett, who is also a member of AIM Global’s RFID Experts Group. “Medical devices can be affected by active tags with stronger signals or RFID systems reading passive tag signals.”
The test protocols developed by GTRI will be submitted to the U.S. Food and Drug Administration for concurrence, after which a worldwide certification program will be launched and other testing facilities will be invited to participate.

Press release: New Protocols Will Test Effects of RFID Systems on Medical Devices…