A Medical Device Daily

eGene (Irvine, California), developer of genetic analysis technology, said it plans to launch a "complete solution for fast and low-cost bird flu screening" by entering into a distribution agreement with Veredus Laboratories (Singapore) for the AIV-H5N1 PCR Kit using eGene's HDA-GT12 System.

Ming Liu, CEO of eGene, said, "We are entering an agreement with Veredus Labs to apply its AIV-H5N1 PCR kit with our HDA-GT12 system. Our previous testing results indicated that the HDA system, in combination with this single-step RT-PCR assay, is a simple and sensitive assay for H5N1 avian influenza detection that can detect as few as 10 copies of the viral RNA."

Liu said a total of 96 samples can be analyzed in less than 50 minutes. "Initially, we believe a fast, sensitive and low-cost analysis to identify the contamination of the viral RNA in the poultry market can be one of the key factors to prevent the mass spread of the virus."

Veredus Laboratories is a molecular diagnostics company engaged in the development, commercialization and manufacturing of diagnostic assays for diseases. The company's focus is to aid patients via faster, more precise and better diagnostics to enable pathogen-specific treatment of infectious diseases at the earliest detectable stage.

eGene developed the HDA-GT12, a high-performance DNA analyzer for genotyping on 12 channels. The system analyzes the genetic fingerprints of living organisms, performing fast DNA sample screening and high-resolution DNA fragment analysis.

The system also analyzes the quality and quantity of RNA in gene expression market.

LCT to conduct trial in Russia

Living Cell Technologies (LCT; Melbourne, Australia) said its DiabeCell Type 1 diabetes treatment has been approved for a Phase I/IIA clinical trial in Russia designed according to FDA guidelines and monitored by GenyResearch Group (Boston), a contract research organization.

DiabeCell is a porcine pancreatic cell product for the treatment of insulin-dependent diabetes. Natural neo-natal pig islet cells are encased in capsules that allow insulin to be released, but prevents the patient's immune system from attacking the cells.

The islets are simply injected into the body and produce insulin as needed in response to the levels of glucose in the blood.

The company said the trial may enable an expedited route to commercialization within the region. Initial response to treatment will be evident within six months.

The trial will use cells from fully screened and biocertified pigs, bred according to FDA guidelines.

"LCT is taking advantage of the growing interest and availability of funds for biotechnology in Russia," said CEO Paul Tan. "The industry has noted Russia's centralized medical infrastructure and efficient recruitment of patients into clinical trials. The rapid regulatory process in Russia and the accepted use of animal cells in treating human disease may shorten the time to market."

Viking adds distributor in Caribbean

Viking Systems (San Diego), a manufacturer of high-performance laparoscopic vision systems for use in minimally invasive surgical (MIS) procedures, has expanded its global distribution network by adding a new partner, Universal Care Corp. (Unicare), for Puerto Rico, the U.S. Virgin Islands, Dominican Republic and the eastern Caribbean, including Trinidad, Tobago and Barbados

Fernando Ledesma, president of Unicare, said, "In addition to the restoration of depth perception, our surgeons are attracted by the comfort of the head-mounted displays versus the strain of viewing a distant monitor especially during longer procedures." He said the use of minimally invasive techniques is growing rapidly growing in the area his company serves, adding: "We believe Viking's 3Di Digital Vision System will become the standard for minimally invasive surgery in the future."

Donald Tucker, Viking president/CEO, said, "We are particularly interested in this geography because of the high growth rate of minimally invasive surgery. Unicare, with its longstanding high-quality representation, is an ideal partner through which [we] can provide our 3-D vision systems to hospitals to address this growth."

Viking said it continues to pursue strategic partners in key markets globally and expects to further penetrate Latin America, Asia and Europe in the near future.

Fluidigm expands R&D in Singapore

Fluidigm (South San Francisco, California) has accelerated its R&D and manufacturing activities in Singapore, through the launch of its new Biomedical Product Development Center. The center, a core part of Fluidigm's worldwide R&D organization, will be responsible for the full development of a Fluidigm BioMark II series of instrumentation.

The company said the BioMark II system will allow it to expand its business into the biomarker validation market, a rapidly growing sector of the life science industry.

Fluidigm said this development makes it the first biotechnology company to expand its portfolio in Singapore, with leading-edge biochip and system R&D capabilities.

The Singapore research group will undertake 100% of the R&D on a new biochip fluorescence reader and biochip loader, specially designed for high-throughput genotyping and protein expression applications. Fluidigm Singapore also will manufacture the BioMark II system.

Operations for the Biomedical Product Development Center will commence immediately, with its current R&D team of five. The company said additional staff will be recruited from Singapore's large pool of manufacturing and research expertise.

Fluidigm set up Fluidigm Singapore as its first offshore R&D and manufacturing operation, introducing breakthrough nanofluidic biochips, known as Integrated Fluidic Circuits (IFC), into the local biomedical sciences scene. Analogous to microprocessors in the semiconductor industry, these IFC biochips can replace roomfuls of lab equipment in the life sciences industry.

"We are very pleased with Fluidigm Singapore's progress over the last year" said Gajus Worthington, president and CEO of Fluidigm. "We look forward to further strengthening Fluidigm Singapore's development capabilities through new technology transfer and applications development."