A Medical Device Daily

Given Imaging (Yokneam, Israel) reported that it has obtained the CE mark for the sale of PillCam Colon 2 in Europe. The company also reported what it said are encouraging results from a trial that validated new features of the company's second-generation PillCam Colon video capsule and system.

The company said it intends to reveal PillCam Colon 2 in Europe at the Gastro 2009 conference this fall at which time it will disclose additional details, including product specifications and software enhancements.

Conducted by clinicians at five hospitals in Israel, the study evaluated the performance of PillCam Colon 2 in 98 patients who had risk or warning symptoms of colon pathology. Like other PillCam capsules in Given Imaging's suite of products, PillCam Colon 2 does not require the use of sedation, intubation or air insufflation during the procedure.

"The main purpose of the trial was to evaluate the performance of new technologies embedded in the new capsule and PillCam platform. The results of this feasibility trial confirm the functionality of the system and give us increased confidence about the potential of PillCam Colon 2 as a useful tool for visualizing pathology in the colon. Despite statistical limitations resulting from the size of the trial and the relatively low prevalence of polyps, we are very pleased with the high degree of consistency in the sensitivity and specificity of the data, both of which were high and balanced," said Homi Shamir, president/CEO of Given Imaging. "We are now initiating additional multicenter clinical trials in Europe and Israel and intend to complete these trials over the next few months. Subsequently, we will begin a phased roll out of PillCam Colon 2 in Europe and a few other countries outside of the U.S. in 2010. On a parallel track, we have initiated pre-registration studies in the United States with leading key opinion leaders to prepare for a subsequent FDA pivotal trial."

PillCam Colon currently is not available for sale in the U.S.

MorphoSys unit in collaboration with FIND

MorphoSys (Munich, Germany) reported that its research and diagnostic antibody segment AbD Serotec (Matinsried, Germany) has initiated a research collaboration with the Foundation for Innovative New Diagnostics (FIND; Geneva, Switzerland), a Swiss foundation that develops, evaluates and accelerates the implementation of new diagnostic tools for poverty-related diseases such as tuberculosis, malaria and sleeping sickness. The goal of the research alliance is to establish a series of heat-stable HuCAL-based antibodies as key components of novel diagnostic tests that are robust in tropical climates. Financial details of the agreement were not disclosed.

Using MorphoSys's proprietary HuCAL technology, AbD Serotec will identify heat-stable fully human antibodies specific for rapid diagnostic test applications for parasite detection.

Currently, rapid diagnostic test applications can allow detection of parasite antigens in a finger prick blood sample. However, most commercial diagnostic tests are developed for storage and use at 25-30 C. High disease burden countries usually have higher ambient temperatures, which can lead to test degradation especially when taking into account the need for delivery to relatively remote locations in the developing world. Thus, temperature stability and prolonged shelf-life of diagnostic kits are critical factors for improving infectious disease control.

Under the terms of the agreement, FIND receives the rights for the commercial use of heat-stable HuCAL-derived antibodies for in vitro diagnostics. AbD Serotec will participate in sales of diagnostic tests using such antibodies in industrialized countries. If concluded successfully, the collaboration could be expanded to cover other disease areas of relevance for FIND's objectives.

CellaVision's analysis added at Swedish labs

CellaVision (Lund, Sweden), which develops and sells digital morphology products for the routine analysis of blood and other body fluids, has received a first order from the Swedish county council Region V stra Götaland as a part of the supply agreement from 2008. The order comprises two units of the CellaVision DM96 analyzer, which will be installed at two of the region's university hospitals with clinical chemistry laboratories. The aim is to tie the whole region together by using software for remote access.

"We have been working with Sahlgrenska University Hospital [Gothenburg] since 2002 and we are very pleased that they are upgrading their current analyzers. The fact that the entire region is introducing digital morphology as a standard method of assessing cells in blood and body fluids is an indication that the transition from manual to automated microscopy is fully under way in the Nordic region," says Yvonne M rtensson, CEO of CellaVision.

CellaVision's products will connect the hospitals in the county council, creating a more efficient flow of cell images and analytical information in the health system. Digital morphology is an important part of establishing a diagnosis for a number of diseases, including certain infections as well as diseases of the blood.

"Introducing digital morphology in all our large clinical chemistry laboratories is part of the region's strive for digitalized laboratory medicine," says Stefan Jacobsson, Associate Professor at the Clinical Chemistry laboratory at the Sahlgrenska University Hospital. "Our experience from the Sahlgrenska and Östra [Gothenburg] hospitals is directing us towards using digital morphology in several units. By using CellaVision's technology we no longer have to rely on sample results and images being transported by post or courier. Instead we use our own network to transfer information, making response times shorter and improving diagnostic quality. This technology also allows us to digitally consult colleagues at other laboratories in the region, which is more efficient."

The Region V stra Götaland and CellaVision entered into the agreement in 2008, aiming at four analyzers with both blood and body fluid applications. The first two will now be installed at the Sahlgrenska and Östra University Hospitals in Gothenburg, and the other two will be installed at two county hospitals. The agreement includes software for networks and remote access, CellaVision Remote Review Software, which will allow the university hospital in Mölndal and four other hospitals to assess cell images remotely. In total, nine hospitals in the county will be equipped with the education software CellaVision Competency Software.