A Diagnostics & Imaging Week

Given Imaging (Yokneam, Israel) said last week that it has received U.S. FDA clearance to market the latest release of its Rapid software, Rapid 4, for use with the PillCam capsule endoscopy platform. New features include smoother video image flow, fast preview and a medical atlas.

The PillCam platform itself is comprised of a disposable miniature video camera within a capsule that is swallowed by the patient so that it passes naturally through the digestive tract while transmitting a flow of high-quality color images of the esophagus then the small intestine, a data recorder worn around the patient’s waist that receives and records signals transmitted by the video capsule as it passes through the gastrointestinal (GI) tract as the patient continues in normal day-to-day activity, and the computer workstation in which the Rapid software to process the data and produce a video of the GI tract is installed.

Given Imaging said that Rapid 4’s new features and diagnostic tools would “significantly” aid the reading and diagnostic interpretation of the captured video stream.

The features include automatic viewing mode that regulates the rate of image change to more smoothly and efficiently review the video stream; a fast preview feature able to highlight potentially important images; and an “atlas” feature that allows the on-screen case image to be compared with known reference images stored in the database, bringing the accumulated Given experience to all users.

The PillCam SB capsule, which Given Imaging calls “the only naturally ingested method for direct visualization of the entire small intestine,” is currently being marketed in the U.S. and more than 50 other countries. The company is developing a complete line of PillCam video capsules for detecting disorders throughout the GI tract, from the stomach through the colon.

The PillCam ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA.

Activity in avian flu sector

The Americas Center (Houston) and Sun Yatsen University Medical Center (Guangzhou, China) have signed a primary affiliation agreement for work aimed at detecting, preventing and treating the H5N1 virus (commonly referred to as avian or bird flu) and its variants.

Sun Yat-sen University Medical Center is the largest medical center and healthcare provider in southern China. The center includes a medical school, eight affiliated hospitals and two medical service clinics.

The two entities have been working together doing translational research, so the new agreement is seen as increasing and leveraging the existing cooperation between them.

“The H5N1 virus could mutate quickly to become a catastrophic pandemic,” said Americas Center Director Kinn Moursund. “By working closely with the largest and most prestigious medical center in southern China, we can greatly accelerate detection and translational research.”

In a statement, the two organizations noted that in a global pandemic scenario, the ability to quickly institute clinical trials on potential treatments or vaccines will be critical.

The Americas Center is primarily composed of individuals and institutions located within the Texas Medical Center (TMC) in Houston, the largest medical center in the world. The Americas Center focuses on global translational research involving multi-site, complex protocols; technology life cycle management in biomedical engineering and information technology; and telehealth and telemedicine training, consultations and collaborations with global healthcare partners.

In other avian flu-related news, MedCap (Toronto) reported that its Chinese joint venture would produce a rapid diagnostic test kit for bird flu. The company said previous attempts to manufacture the test kit have been hampered by the fact that the joint venture was not able to get access to the avian flu antigens necessary to produce the test strips.

MedCap said its Chinese partners have now acquired access to the antigens that will allow the company to produce the rapid diagnostic test strips. MedCap will contribute its technology developed with its AccuScan test kits.

Two test kits will be developed, one to test birds for the avian flu and one for use on humans. The initial kit will be to detect the avian flu in birds. The company’s technical staff estimates that kit will be available for the market within three to four months.

The current testing for avian flu takes three to seven days and must be done in a laboratory. “During this time the virus spreads rapidly, infecting an entire flock,” said MedCap.

The new test kit will use blood and will give results in less than 20 minutes. The test kit will be used in the field to isolate infected animals, “and will potentially save hundreds of thousands of the flock from being destroyed through early detection,” MedCap said in a statement.

Microbead ‘developer’s kit’ unveiled

Ferrotec (Tokyo) has introduced the Magnetic Nano Particles (MNP) Developer’s Kit, a set of solutions suited for synthesis of microbeads used for in vitro diagnostic (IVD) applications.

The company said its MNP products have the capability of “significantly increasing” the microbead surface area, thus enabling improved responsiveness, accuracy and specificity for IVD applications such as immunoassays, bio-separations and molecular diagnostics.

Ferrotec describes itself as the industry leader in producing nano-scale ferrofluids. It noted that superparamagnetic polymer microbeads are used in many of today’s most advanced biotechnology and life science processes.

“Coated with material that traps target elements [such as] antibodies, DNA or proteins and then enables the surrounding materials to be washed away, microbeads are used in genomics, proteomics, and many diagnostic techniques,” the company said.

At the heart of these tiny beads are magnetic particles that shape the bead’s performance. Ferrotec’s MNP Developer’s Kit is a collection of seven samples of nanoparticle suspensions that are optimized for synthesizing microbead polymers with different performance characteristics.

“With the MNP Developer’s Kit, we’re leveraging our particle technology expertise to enable core improvements the fields of biotechnology, life science and diagnostic healthcare,” said Shiro Tsuda, general manager of the Ferrofluid division of Ferrotec. “[The kit] provides diagnostic researchers and engineers with nanoscale particle solutions with performance characteristics previously unavailable in the life sciences industry for microbeads with dramatically improved receptor attachment.”

VScan TB kit gets Ukraine recommendation

Medical Services International (MSI; Edmonton, Alberta) said it has completed testing of its VScan Tuberculosis (TB) test kit with the National Institute of Tuberculosis in the Republic of Ukraine, with “excellent results,” according to the company.

The results showed that the VScan TB test kit had greater than 80% accuracy. The company said there is no other rapid test kit available on the market that has results as high as its kit.

It said the institute recommended that the VScan TB test kit be used in practical investigation for TB, as well as for specialized diagnostic medicine in the Ukraine.

MSI said the recommendation will allow it to get approval in up to four additional countries in Eastern Europe, and said it is reasonable to expect sales of 3 million to 5 million VScan TB test kits in the first year.

The company said tuberculosis is “extremely prevalent” throughout Eastern Europe.

Medical Services International also said it has received an order from a Dubai-based company for 1 million VScan test kits to be delivered throughout 2006. The majority of the kits ordered will be the VScan HIV kits.

iCAD system set for use in China screening

iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) solutions, reported that its SecondLook systems have been selected for use in the new “Million Women Breast Cancer Screening” project to be undertaken by the Chinese Anti-Cancer Association.

With breast cancer seen as a growing women’s health issue in China, the Million Women screening program is intended to increase early detection throughout the country. The Chinese Anti-Cancer Association has entered into a five-year agreement with iCAD’s distributor in China for a minimum of 100 SecondLook systems.

iCAD said it has received the first order under the agreement, in the amount of about $426,000, for 20 film-based CAD systems that are designed and configured for the Chinese agency. The company said it expects the systems to be shipped this month.

Japanese distribution agreement signed

Pressure BioSciences (West Bridgewater, Massachusetts) said it has signed a one-year distribution agreement with Veritas (Tokyo). Under the terms of the agreement, Veritas will have exclusive distribution rights to all PBI products in Japan, including the recently released Barocycler NEP3229 Bench Top model.

The agreement also contains a provision to extend the Dec. 31, 2006, expiration date for an additional three years with the consent of both companies.

Veritas has purchased two Barocycler NEP3229 Bench Top units for demonstration, training and instructional purposes and unveiled the product at last week’s annual meeting of the Molecular Biology Society of Japan in Fukuoka.

Following the sale of substantially all the assets and selected liabilities of its BBI Diagnostics and BBI Biotech divisions to SeraCare Life Sciences in September 2004, Boston Biomedica changed its name to Pressure BioSciences.

The company is focused on development of its Pressure Cycling Technology for use in genomic and proteomic sample preparation, pathogen inactivation, control of enzymes, immunodiagnostics and protein purification.

Another SurePath contract award

TriPath Imaging (Burlington, North Carolina) said Medical Solutions (Leeds, UK), its distributor in the UK), has been awarded a five-year contract to supply the company’s SurePath liquid-based Pap test to the South York-shire Cytology Trusts.

Ray Swanson, senior vice president of commercial operations of TriPath Imaging, said that with the new contract, the company has cumulative commitments that represent nearly 36% of the liquid-based Pap test market in the UK, 38% in England and Wales.

“We expect to continue to grow our opportunity in the UK as other regions finalize their decisions,” he said.