A Medical Device Daily

"Lumera" (Bothell, Washington), focused on nanotechnology, reported extending its collaboration with the Institute for Systems Biology (ISB; Seattle) with the goal of using Lumera's ProteomicProcessor to identify biomarkers associated with drug toxicity and cancer.

As previously reported, ISB researchers have demonstrated a label-free assay to determine protein expression patterns using a panel of specific antibodies printed on Lumera's NanoCapture-Gold microarray and analyzed on the company's ProteomicProcessor instrument system.

"We are quite pleased with the progress of the past year," said Dr. Leroy Hood, ISB president. "Lumera's platform provides unique advantages in biomarker discovery, and we are committed to moving the science forward."

"Early results from ISB have been proof positive that our technology adds significant value to the biomarker discovery market. We feel that with a continued emphasis on this project, we will arrive at a very important publication and will establish methods by which others will be able to develop their own assays," said Dr. Timothy Londergan of Lumera's Bioscience Business Unit.

Practical, political hurdles in path of e-card program

An open question among eHealth Week participants in Berlin last month was whether Germany can keep to its schedule.

On a practical level, can the secure connectors — the most sensitive piece of the system — be certified as secure enough for Germany's tough data protection laws that are enforced by a ministerial-level office? And can manufacturers produce and get to market the approved reader-connectors by 2008 when Gematik, the non-profit agency charged with designing, implementing and eventually assuring the operation of the system, has not yet approved any device?

Finally, there is a formidable resistance to both the program and Gematik throughout Germany among multiple interest groups, which could cause the program to grind to a standstill. How many doctors, who are required to purchase and install the equipment, are willing, or even ready, to bring a high-speed connection into their practice?

"From the field tests we have learned the devices work, that much has been established," said Doris Pfeiffer, speaking for Gematik and the Association of the Health Insurance Funds in a plenary discussion during the conference. "Acceptance is another point," she acknowledged, "and we are experiencing growing pains."

Pfeiffer added: "There are critics on the issue of data protection, for example. My experience is that these are largely people who are afraid of a coming transparency the system will create. Patient groups, for example, very much like the transparency and give it strong support. The problem is that patients would be more likely to accept cards if their doctors were in support of it."

Volker Amelung, managing director of the German Managed Care Association (Berlin), said in principle the German healthcare system is self-governing, with decision-making distributed among the 16 autonomous states and hundreds of insurance funds. Traditionally the federal ministry intervenes when there is a conflict or when the process is failing.

Yet the eGK program is unusual because it is a federal program and the Health Ministry itself has become the focus for the ire of the diverse interest groups.

"We have hundreds of associations, insurance funds, physician organizations and the patient organizations," said Amelung. "The decision-making process, which in Germany operates on the principle that everyone must agree on everything, has been exposed for its weaknesses with the e-card."

— John Brosky, Contributing Writer