Diagnostics & Imaging Weeks

First results from a proof-of-concept study of 10 diabetes patients confirm the viability of the everyday monitoring for a novel Swiss multi-sensor device for non-invasive glucose monitoring.

Patients logged 110 days wearing the sensor-loaded armband from Solianis Monitoring (Zurich) that captured data from 10 standard blood glucose measurements each day.

Though the data is transferred wirelessly to a standard pocket computer, there is no display of information for the patient and the data is sent to Solianis each evening for analysis.

The company notes several non-invasive devices for glucose measurements have shown promising results in measuring glucose levels under controlled conditions but failed to address the challenge of everyday conditions that include factors disruptive to reliable measurement, such as changing body temperature, microcirculation, sweat, moisture or thickness of different skin layers.

Tucked in an elastic armband, the Solanis prototype model called FM2b carries software onboard for a hardware package that includes multiple sensors, the electronics for signal generation, data storage, a battery and wireless communication.

CEO Mario Stark said that by the end of September, Solanis will complete two more study phases with concurrent product redesign, at which point the functional design will be frozen.

He told Diagnostics & Imaging Week the next phase will test 16 patients with diabetes Type 1 over 25 days each.

He said Solanis is working with the University Hospital in Zürich for patient selection and support.

Stark said he expects to receive CE-mark approval and launch the monitor in Europe by 2010, targeted at the insulin-dependent diabetes population.

"Solianis' sensor technology lends itself to integration with other technologies," he said, adding that the glucose data can be integrated with insulin pumps as a feedback mechanism, ultimately leading toward a closed-loop system.

Later product generations will address all potential patients with diabetes and impaired glucose tolerance.

Siemens moving diagnostics research center

Siemens Healthcare (Erlangen, Germany) said it will set up its European research center for molecular diagnostics in Cologne, Germany, moving out of the Bayer Technology Services campus in nearby Leverkusen.

The move is part of the heavy lifting as Siemens integrates the operations of Bayer Diagnostics that it bought two years ago for $5.3 billion, catapulting the radiology giant to the top ranks of in vitro diagnostics competitors.

The European center in Cologne specializes in developing innovative biochips, the lab-on-chip tests that use a combination of microfluidics, electro-chemical reactions and diverse sensors to determine the presence of biomarkers linked to specific disease states.

Siemens set out to become a one-stop shop for medical diagnosis by adding to its established line of radiology and imaging products the emerging bio-chemical technologies that promise a more personalized medicine by quickly screening for diseases and then tailoring therapies to address specific patient conditions.

Siemens moved quickly over the course of a year, spending $14 billion to purchase Diagnostic Products Corp., Bayer Diagnostics and Dade Behring, which were integrated into the Siemens Medical division.

The company reports the division's income up 20% to €9.8 billion ($15.2 billion) and the group's profits up 34% at €1.3 billion ($2 billion).

Chlamydia test from Roche OK'd

Roche Molecular Diagnostics (Pleasanton, California) said its new Cobas TaqMan CT Test v2.0 for detection of Chlamydia trachomatis has received CE-mark approval.

The company said the test is designed with a dual-target approach to help ensure reliability of test results even when mutations occur in the bacteria's cryptic plasmid DNA.

According to Eurosurveillance, an independent scientific journal, C. trachomatis is the most commonly reported sexually transmitted disease in Europe. Although it often causes no symptoms, Chlamydia can, if left untreated, lead to complications such as pelvic inflammatory disease or infertility in women.

"Unexpected mutations in the DNA of an infectious agent such as Chlamydia can disrupt laboratory testing and, by extension, proper treatment of patients," said Teresa Wright, MD, chief medical officer at Roche Molecular Diagnostics. "Because it is impossible to predict when these mutations will occur, we have designed this test to detect all Chlamydia strains that may cause a deletion in the cryptic plasmid, including the variant originally detected in Sweden in 2006."

Italian distributor signed by SpectraScience

SpectraScience (San Diego) said it has established a distribution partnership for its WavSTAT Optical Biopsy System in the Italian market through Medimar Italia (Milan).

Michel Vaudry, director of international sales, said, "We are pleased to have added our second European distributor in the past two months. Medimar is a respected and well-established medical device distributor and its decision to add the WavSTAT Optical Biopsy System to its portfolio is a strong validation of our technology."

Medimar's president, Francesco Torelli, said, "SpectraScience's WavSTAT cancer diagnosis system has tremendous potential to impact the marketplace here in Italy. The importance of earlier and more effective screening for colon cancer cannot be stressed enough; we look forward to representing the product and [building] a strong Italian market presence."

The WavSTAT Optical Biopsy System helps physicians discern between normal and pre-cancerous tissue in the GI tract, providing additional information that allows for a more informed decision on leaving polyps on-site if they are not pre-cancerous.

Hospital attaches X-rays to patient health card

In other Siemens-related news, one of Germany's largest hospitals, Klinikum Chemnitz (Chemnitz, Germany), reported that it has integrated radiology services with a patient's electronic health record, using one of the company's systems.

Radiology images, as well as diagnosis and corresponding findings, are merged in a single record with demographic and administrative data for an individual patient who may have received treatment at any of the 22 clinics run by Klinikum Chemnitz in a region that includes Leipzig and Dresden.

Klinikum Chemnitz is one of the Europe's only medical centers to be accredited by Joint Commission International (Oakbrook Terrace, Illinois).

Siemens Medical supplied and implemented the system, including the software for radiology information communication and the Soarian eHealth Solution for the electronic health record.

Patient consent is required to start the automatic data flow which is accessible only to authorized healthcare professionals on a secure system, essential in Germany that features the toughest data protection laws in Europe and has a ministry dedicated to enforcing the rules.

Crossing institutional borders with electronic records "offers cost-cutting potentials to the entire network optimal communication, a basic requirement for smooth workflows between service providers," said Dr. Olaf Schlimpert, head of the medical information technology department at Klinikum Chemnitz.