A Medical Device Daily

HemoCue (Angelholm, Sweden) has unveiled an entirely new single-analyte point-of-care (POC) testing system for determination of total white blood cell count.

The new system was on display at last week's American Association of Clinical Chemistry (Washington) annual meeting in Chicago. The company said the test is so simple that it can be performed in any physician's office within minutes and will be, it added, “a valuable tool in the diagnosis of bacterial infections.”

The HemoCue WBC testing system for total white blood cell (WBC) count will be used to rapidly diagnose infections and will substantially improve quality in primary care, the company said. Instead of sending blood samples to a reference lab, the system will provide immediate and reliable results with the same precision and accuracy as a lab test, onsite and within minutes, HemoCue said.

Since an increased total WBC count is typically seen in patients with bacterial infections, HemoCue WBC will assist physicians in the decision on whether to prescribe antibiotics or not. The company said over-prescription of antibiotics is a major concern resulting in an increasing number of bacterial strains being resistant to antibiotics.

“Our new point-of-care system for measuring total WBC will help physicians prescribe antibiotics to patients in need of it without unnecessary delay and to avoid prescribing it to patients where it has no effect,” says Stellan Lindberg, director of R&D at HemoCue. “So far we have presented HemoCue WBC to a small number of experts at large central hospital laboratories and to physicians in primary care settings. They have been very impressed by the simplicity and accuracy of our system.”

The WBC system is based on HemoCue's proven cuv-ette technology and is specifically designed for receiving a waived categorization under the U.S. government's Clinical Laboratory Improvements Amendments program. The system will be tested on a large scale in the beginning of next year by a number of clinics in Sweden and the U.S., with anticipated commercialization in 2Q07.

HemoCue is owned by EQT , a leading Northern Europe private equity group.

First Ablatherm in Portugal begins service

EDAP TMS (Lyon, France), a leader in products for high-intensity focused ultrasound (HIFU) treatment of prostate cancer, reported the launch of Ablatherm-HIFU services at Hospital Privado da Boavista (Porto, Portugal), the first HIFU treatment center in that country. The hospital will be using the Ablatherm-HIFU device under EDAP's fixed installation revenue-per-procedure model.

The company said Dr. Miguel Silva-Ramos of Boavista treated the first Portuguese patients with the Ablatherm system earlier this year, and the center then decided to contract for a fixed-RPP model.

In July additional patients were treated on the Ablatherm-HIFU device using the integrated imaging system. Dr. Adriano Pimenta, head of urology, said, “The decision to begin with HIFU treatments was logical since it is a minimally invasive treatment with very few and often light side effects, with oncologic results similar to other therapies with curative intent.”

Silva-Ramos said, “Ablatherm-HIFU represents a new level of noninvasive care for our patients who are not candidates for surgery or desire a treatment with a minimum of disruption in their lifestyle. The Ablatherm is clearly the most advanced HIFU device for localized prostate cancer, offering patients an effective, safe and attractive treatment choice for their consideration.

The launch of service in Portugal continues the rollout of Ablatherm-HIFU in Europe, where treatment now is available at more than 100 centers in several countries.

Genome analysis kit launched

Kreatech Biotechnology (Amsterdam, the Netherlands) reported the launch of its Genome-pULSe, arrayCGH Whole Genome Amplification and Labeling Kit, the latest addition to the company's product portfolio for arrayCGH analysis.

This kit combines Qiagen 's (Venlo, the Netherlands) whole-genome amplification (WGA) technology, which allows amplification of very small amounts of genomic DNA isolated from tissue or cells, with Kreatech's ULS reagents necessary to label these samples for arrayCGH analysis, thus offering what the latter firm characterized as “a more complete solution to scientists carrying out arrayCGH analysis.”

The Genome-pULSe Kit is available with the ULS labeling molecule bound to Cy3 and Cy5 dyes licensed from GE Healthcare (Chalfont St. Giles, UK). The WGA technology included in the kit is the REPLI-g kit from Qiagen.

Kreatech said ArrayCGH analysis of particular samples, such as small-needle tumor biopsies, can be limited by the small amount of sample available. It said that traditional methods of genomic DNA amplification include the time-consuming process of creating EBV-transformed cell lines followed by whole-genome amplification using random or degenerate oligonucleotide-primed polymerase chain reaction (PCR).

However, the company noted that PCR-based methods can generate non-specific amplification artefacts, resulting in the incomplete coverage of loci. In addition, conventional methods that are based on enzymatic incorporation of modified nucleotides used to label the amplified DNA for subsequent microarray analysis could further increase the bias in locus representation.

The Genome-pULSe Kit delivers a novel procedure for the uniform amplification and subsequent direct (non-enzymatic) labeling of whole-genome DNA from small samples, a method designed to provide a quick and highly reproducible amplification and labeling procedure for arrayCGH analysis.

Kreatech's vice president of commercial operations, Brent Keller, said, “This is the first amplification and labeling kit available for arrayCGH analysis that enables customers to detect genetic aberrations without introducing bias during the amplification and labeling unlike conventional amplification and enzymatic labeling procedures”