A Medical Device Daily
Orchid BioSciences (Princeton, New Jersey), a worldwide provider of identity DNA testing services, last week reported the launch of a new testing kit for scrapie susceptibility based on what it described as its "highly accurate and robust proprietary genotyping assay."
The largest provider of scrapie susceptibility genotyping in the world, Orchid already has used the assay to genotype more than 1.3 million sheep in its UK-based, high-throughput scrapie susceptibility testing service.
Scrapie is a fatal transmissible spongiform encephalopathy (TSE) that affects sheep worldwide and, according to Orchid, "has the potential to cause significant economic losses to farmers through the destruction of infected animals and by affecting confidence in the safety of the food supply."
The company said the new kit has been designed for customers with lower-throughput testing requirements who want to benefit from the accuracy of this analytical approach when conducting sheep genotyping in their own laboratories.
David Hartshorne, commercial director of Orchid Europe (Abingdon, UK), said, "This new offering reinforces our focus on exceptional service, whereby we work with our customers to determine the most practical and cost-effective scrapie genotyping solution for their needs, whether it be conducted in our facility or in their own laboratory."
European Union legislation requires countries to introduce compulsory scrapie genotyping programs beginning in April.
Orchid also reported that it has signed an agreement with Prion Diagnostica (Milan, Italy) to commercialize the new scrapie susceptibility testing kit in that country. Prion develops diagnostic products and services in a number of different veterinary and food safety applications and is a leading provider of rapid diagnostic tests for bovine spongiform encephalopathy ("mad cow" disease).
Italy has an estimated sheep population of more than 11 million and, like most European countries, has occasionally found prion-infected sheep in its flocks.
Since 2001, Orchid has been a supplier of genotyping services to UK sheep farmers under the government's National Scrapie Plan, which is designed to help farmers breed sheep with reduced susceptibility to scrapie. Scientists have discovered a number of genetic variations that affect an individual sheep's susceptibility to scrapie. By selecting those sheep with high genetic resistance as breeding stock, over time farmers expect to produce flocks with greatly reduced vulnerability to the condition.
Orchid also is the exclusive genotyping supplier to the Northern Ireland Scrapie Plan and provides a commercial testing service directly to farmers in the UK. It established its European headquarters in 2001 through the acquisition of Cellmark Diagnostics, one of the world's first commercial DNA testing laboratories.
SCM eyes healthcard terminal market
SCM Microsystems (Fremont, California) last week unveiled plans to enter the market for hardware terminals designed to read the new German electronic healthcard. The announcement was made at the CeBIT exhibition in Hanover, Germany, where SCM is showing prototypes of the new terminal for doctors and pharmacies from through Wednesday.
The company also is demonstrating the new terminal at the booth of its partners, Giesecke & Devrient, and another booth operated by IBM and Giesecke & Devrient.
Germany is in the process of deploying a new "intelligent" electronic healthcard to its citizens, with 80 million intelligent healthcards expected to be in use by 2006.
SCM said the new chip-based healthcards "are intended to bring greater efficiency and cost control to the German healthcare system while safeguarding confidential patient-related data."
The healthcards will require a new terminal infrastructure for healthcare providers. Beginning in 4Q05, it is anticipated that 1.2 million terminals will be shipped to doctors and dentists' offices, pharmacies, clinics and hospitals in that country.
SCM's new terminal solution will read and operate both with Germany's current memory card-based healthcard as well as with the new intelligent chip-based healthcard. The SCM terminal can be connected via USB or a serial interface to stand-alone PCs or alternatively can be used in a network environment within or between doctors' offices, pharmacies and hospitals.
Within the new healthcard program, three different types of cards will be used: the electronic healthcard for people covered by their health insurance, a health professional card for doctors and pharmacists and a secure module card in a SIM card form factor. SCM, which said it would participate in this market together with its partners, indicated that its terminals are designed to read all three types of cards.
SCM Microsystems' European headquarters is in Ismaning, Germany.
Funding from Finland for CRF
CRF (Waltham, Massachusetts/Helsinki, Finland), a global provider of electronic patient-reported outcomes (ePRO) and wireless data collection solutions, said it has secured $1.3 million (EUR 1 million) from the National Technology Agency of Finland (Tekes; Helsinki).
The company will use the funds to continue research and development of its ePRO technology, TrialMax. TrialMax is a customizable ePRO technology that provides real-time patient monitoring, outstanding data accuracy and increased safety. Its features enable clinical trial sponsors to collect more valuable data faster and conduct complex clinical trials with greater flexibility than other ePRO solutions.
CRF said this latest round of funding will enable it to further advance the capabilities of TrialMax in pharmaceutical clinical trials and to broaden the company's reach into post-clinical trial monitoring and personal health management applications.
"Initial funding from Tekes in 2003 enabled us to develop TrialMax and establish an undisputed technology advantage," said Timo Ahopelto, vice president of operations and co-founder of CRF. "We've built upon this technology platform with unparalleled customer support and a results-driven approach that has secured our status as a trusted partner in the pharmaceutical industry."
Ahopelto said the latest investment from Tekes "will assist us in our efforts to expand the role of ePRO technology in healthcare."
"CRF is one of the most prominent technology companies in Finland," said Juha Tanskanen, technology advisor at Tekes. "In addition to their technological prowess, they also know how technology is best designed to help customers in their most important processes."
Tekes is the main public financing and expert organization for research and technological development in Finland. It has a budget of EUR 400 million, a source of funding for 2,000 projects annually.