Diagnostics & Imaging Week

With the introduction of new players in the competitive landscape and accuracy levels improving, rapid tests are beginning to overcome initial resistance. These emerging players have the ability to potentially increase the addressable market and product awareness, according to Frost & Sullivan.

The global consulting firm finds that providers of rapid tests for infectious diseases in Latin America earned revenues of $28 million in 2005 and estimates them to reach $40 million in 2010.

"The ability of new rapid tests to be dispersed at fractionally low cost across large distances makes it an especially attractive market for the Latin American region," says Frost & Sullivan Research Analyst Natalia Scomparin.

Geographical and healthcare barriers restricting access to the basic infrastructure needed to perform traditional testing, together with higher levels of accuracy that the rapid tests technologies are offering, are the two key factors propelling the expected growth of this market.

"Lack of promotion of these techniques together with yet-unexplored potential market users are two avenues to closely consider when targeting growth objectives among this category," notes Scomparin.

As the market reaches a more mature level of development, new Tier 1 entrants expect to use a combination of price and niche product strategy to reach the higher end of the potential addressable market size in the medium and long term.

IDSI presents at Sao Paulo meeting

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida) displayed CT Laser Mammography (CTLM) clinical cases from international partner sites at the 36th annual meeting of the Sao Paulo Society of Radiology (Sao Paulo, Brazil) as part of its push to commercialize the system in Central and South America.

The company said the cases highlight the capability of its CTLM technology to image angiogenesis, usually associated with breast cancer.

The Sao Paulo exhibition marked the third major South American conference attended in a 10-month period, the company said. IDSI exhibited in a booth with Pyramid Medical Systems, one of Brazil's largest medical device distributors.

The CTLM system is the first breast imaging system that utilizes laser technology and patented algorithms to create 3-D cross-sectional images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression.

Applied Imaging a partner in study

Applied Imaging (San Jose, California) said its wholly owned subsidiary, Applied Imaging International, is one of three partners accepted as a collaborator in the DISMAL(1)-project, a European-based, three-year biomarker study directed toward the detection and dissemination of tumor cells.

The venture was organized and funded by the European Union, and is comprised of 11 academic research centers and three commercial partners with long-term expertise in micro metastasis research. It is being led by Dr. Klaus Pantel, professor at the University Medical Center Hamburg-Eppendorf.

In its role in the DISMAL project, Applied Imaging will develop scanning hardware and software for fast and accurate detection of disseminated tumor cells (DTC) based on its Ariol platform's rare cell detection and analysis capabilities.

The project includes developments for improved DTC detection using high speed image processing technology, as well as the development of detection algorithms and data transfer software.

Robin Stracey, president and CEO of Applied Imaging, said, "We are pleased to be the only imaging company collaborating on this high-profile study into the detection and characterization of tumor cells. We expect our work on the DISMAL project will be incorporated into the circulating tumor cell (CTC) system we are developing and will further enhance the presence of our Ariol systems in cancer research and diagnostics in the European market."

The DISMAL project has received research funding from the European Community's Sixth Framework Program.

TomTec unveils RV function software

TomTec Imaging Systems (Munich, Germany) has introduced its 4D RV-Function software, for right ventricular function analysis. The software enables fast measurements of RV functional parameters basing on 3-D echocardiographic datasets.

The company said current limitations in right ventricular diagnostics are mainly caused by the complex shape of the RV and can be overcome with this new product.

TomTec said it worked with cardiologists and pediatricians to develop an application that meets the growing demand for better and more accessible quantifications of right ventricular function, which is important in cases such as heart failure, pulmonary disease and congenital heart disease. Fast and accurate quantifications have an immediate application in managing and treating patients with such conditions.

The firm said the current "gold standard" for assessing right ventricular function is MRI, but the limited availability, high costs and time-consuming evaluation associated with MRI have limited its usefulness.

It added that 2-D echocardiographic techniques for quantitative analysis of the right ventricle, which are easier, low cost and relatively fast, are limited by the complex shape of the right ventricle.

TomTec said its new technology uses 3-D ultrasound data sets "to combine the ease and speed of echocardiography with the accuracy of MRI." The software calculates a 3-D right ventricular surface model automatically from the endocardial contours in the 3-D data set. It uses that model to measure right ventricular end diastolic volume, end systolic volume and ejection fraction.

MSI cites Ukraine test results

Medical Services International (MSI; Edmonton, Alberta), which has been approved to sell VScan HIV test kits in Ukraine since June 2005, said it has just received the official report related to the testing that was completed by health authorities in that country.

The report shows that the VScan HIV test kits had a specificity of 100% and a sensitivity of 99.8%.

MSI said that the Ukraine report, combined with test results from other European health authorities, will be used in the application for CE-mark approval in the European Union.

It is anticipated that the report will be submitted within the next two weeks. The company said approval in the EU will allow it to market the VScan HIV test kit in another 26 countries.

Preliminary market studies indicate that MSI will sell in excess of 1.5 million kits in the first year after receiving EU approval.

The company said the outstanding test results obtained in Eastern Europe are the reason that the VScan test kits are receiving such a positive response elsewhere.

1st Niris system shipped to Australia

Imalux (Cleveland) reported that it has shipped its first Niris imaging system to the Australian market via its exclusive distributor, Device Technologies Australia. The company said the milestone is a key achievement in its market development and product introduction activity in that country.

The initial shipment comes on the heels of other market development activity, including image interpretation training for Device Technologies Australia sales and marketing personnel provided by Imalux staff.

Niris is a point-of-care system that creates images using near-infrared light, providing clinicians with real-time, high spatial resolution, 2-D, cross-sectional depth visualization of normal and abnormal tissue microstructures. Imalux said the spatial resolution of the system is on the order of 0.01 mm, surpassing conventional ultrasound by an order of magnitude.

The Niris imaging system was presented at the Urological Society of Australasia's annual scientific meeting in March, the largest gathering of urology professionals in Australasia. The system is designed to assist physicians in the diagnosis, treatment and monitoring of diseases in multiple specialties, including urology, gastroenterology, gynecology, dermatology, dentistry and ear, nose and throat applications.

Imalux OCT technology has been used with more than 3,000 patients worldwide. The system is FDA-cleared.

Philips donates ultrasound systems

Royal Philips Electronics (Andover, Massachusetts) reported that it has agreed to donate 50 ultrasound systems, valued at an estimated $2.6 million, to the Global Ultrasound Equipment Donation Foundation (GUEDF), a not-for-profit organization that provides ultrasound equipment and training to needy clinics, hospitals and teaching facilities in emerging and developing countries around the world.

The company said the equipment will help patients receive care that is equivalent with many developed nations.

Barbara Franciose, CEO of Philips' ultrasound and monitoring business, said, "This partnership with GUEDF will help give our efforts a significant boost."

The donation includes systems used for echocardiology, radiology and obstetrics. They are equipped with modern ultrasound technologies such as SonoCT and 3-D imaging that the benefiting institutions could not have afforded on their own.

The first system from this donation, a Philips HDI 5000, is being presented to Seoul City General Hospital, East Branch (Seoul, South Korea). Used for general imaging, including ob/gyn, breast, vascular, abdominal and adult cardiology, the system's SonoCT compound imaging and 3-D capabilities will allow the hospital to provide under-served patients in Seoul advanced care currently unavailable to them.

Since established in 2003, GUEDF says it has provided more than 200 ultrasound systems to hospitals and clinics in more than 25 countries.

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