A Diagnostics & Imaging Week

SciBase (Stockholm, Sweden), developer of a proprietary method for quick, simple and accurate detection of skin cancer, has added Investor Growth Capital as a new investor.

Investor Growth Capital is the wholly owned venture capital arm of Investor AB, the largest industrial holding company in the Nordic region.

Investor Growth Capital, together with previous investors SEB Foretagsinvest and Capman, control 80% of the Swedish medical technology company. CapMan and SEB have provided SEK 50 million of the SEK 100 million total investment in the firm.

The latest investment was done as a new share issue.

"Getting the Investor Growth Capital as a new owner is additional proof that our method and technology have a lot of potential," said SciBase CEO Christer Wallin.

"There is an enormous interest for early, safe and simple detection of skin cancer, and SciBase's method has been welcomed. It can mean saving lives, suffering, time and money. Our ambition is to deliver results in each of these areas, and thereby making SciBase a world leader in the fight against skin cancer," said Wallin.

"SciBase represents an inspiring medical device investment for us at Investor Growth Capital," said Jakob Lindberg of that firm. "There is a large clinical need that is unmet, a market potential in the multibillion SEK range, and a proprietary product with extremely good sensitivity and specificity."

He added: "Skin cancer is one of the fastest-growing types of cancer in the world and as experts in the field already know, the available diagnostic tools are highly unsatisfactory."

The research behind the SciBase product development has been conducted at Karolinska Instititute (also Stockholm), under the direction of Associate Professor Stig Ollmar.

With the SciBase technology it is possible to discover skin cancer within just a few minutes. The area of skin in question can be examined quickly and simply with the help of a probe. At the end of the probe is a disposable sensor that is connected to a computer that interprets the information.

Seven clinical studies have been conducted on more than 1,200 people. Another 700 people are currently participating in clinical studies. The market launch for the product is planned for 2007-2008. Among the potential customers are hospitals, as well as individual clinics.

New guidelines on PillCam endoscopy

Given Imaging (Yokneam, Israel) said that physicians at the International Conference on Capsule Endoscopy (ICCE), held earlier this month in Paris, revised consensus guidelines for PillCam capsule endoscopy use based on the growing body of data presented at the conference.

This year's conference highlighted more than 80 abstracts, of which 19 were accepted for oral presentation. More than 300 physicians participated in the meeting.

"ICCE Paris is an opportunity for European physicians to share the latest information about new and expanded indications for capsule endoscopy. There were several large studies which validated earlier findings about the impact of capsule endoscopy on clinical outcomes, in identifying small-bowel tumors and in definitely detecting Crohn's disease," said Roberto De Franchis, MD, professor of medicine at the University of Milan (Milan, Italy) and co-chairman of the conference.

Three posters were selected for presentation during a plenary session:

• Researchers at the Georges Pompidou European Hospital (Paris) examined the diagnostic yield of capsule endoscopy in detecting lesions outside of the small intestine that are missed by traditional endoscopy. They identified a cause of bleeding outside of the small intestine in 26 patients, or 7% of cases. Lesions were found in the stomach, proximal duodenum and cecum.

• A team of researchers at the Martin-Luther University Hospitals and Clinics in Germany, conducted a 22-patient study comparing the comfort of capsule endoscopy in diagnosing small bowel to MRI and enteroclysis. Patient comfort was graded in a questionnaire on a scale of 0 for no stress at all to 10 for unbearable stress for each imaging method. The mean stress grade for capsule endoscopy was 1.1, significantly less than stress associated with MRI (4.4) and enteroclysis (5.6).

• Physicians from the Digestive Endoscopy Unit at Catholic University (Rome) evaluated the feasibility and safety of non-assisted capsule endoscopy in 11 patients who previously had undergone stomach surgery. In nine of the 11 patients, the capsule passed into the small bowel directly as confirmed by fluoroscopy. In two other patients, endoscopy assisted positioning of the capsule was necessary. Researchers concluded that capsule endoscopy is safe and feasible in patients who have undergone gastro-duodenal surgery.

Tm signs Dutch distributor for RVP

Tm Bioscience (Toronto), a developer of genetic tests, said it has signed a distribution agreement with Sanbio to commercialize the company's ID-Tag Respiratory Viral Panel (RVP) in the Netherlands. The ID-Tag RVP detects and discriminates between 20 respiratory viruses, including avian flu and sudden acute respiratory syndrome (SARS).

"Signing our first European distribution agreement for our ID-Tag RVP is an important milestone in our global commercialization strategy for this product," said Greg Hines, president and CEO of Tm Bioscience. He said the company intends to complete a series of distribution agreements across Europe over the coming months to be positioned for the rapid commercialization of the test upon gaining European regulatory clearance, which Tm anticipates achieving yet this year.

The company said the ID-Tag Respiratory Viral Panel is a molecular diagnostic test that has the potential to play a key role in the diagnosis of respiratory viruses in clinical settings in addition to its role as a tool to assist in managing the pandemic threat of avian flu. Tm Bioscience's strategy is to make the ID-Tag RVP product a worldwide standard for use in patient and resource management in clinical environments as well as for use in public health programs.

Sanbio is a leading distribution company based in the Netherlands which supplies products for research and diagnostics in the Benelux countries to universities, research institutes, pharmaceutical and biotech companies. It also develops and manufactures a broad line of monoclonal antibodies under its own brand name, Monosan, which are sold through worldwide distribution on network.

Tm Bioscience expects that the ID-Tag RVP will address two key markets – first as a cornerstone diagnostic product in the clinical setting for the more efficient management and treatment of patients who may be infected by respiratory viruses, and also in managing potential pandemic threats via adoption by the global public health community.

Tm Bioscience is a DNA-based diagnostics company developing a suite of genetic tests. Its product pipeline includes tests for genetic disorders, drug metabolism and infectious diseases.

MSI eyes CE-mark certification

Medical Services International (MSI; Edmonton, Alberta) said it has completed the necessary documentation to apply for CE-mark certification of its VScan HIV test kits in Europe.

As reported earlier, MSI has agreed to a proposal from a European pharmaceutical company whereby they would pay the costs necessary, look after the submission of all data and complete any and all other procedures required to obtain certification of the VScan HIV test kit.

The European firm has now received all required documentation from Medical Services and has indicated that the application will be submitted to the appropriate authorities as soon as possible, MSI said.

Certification of the Vscan HIV test kit would allow the VScan HIV test kit to be sold in an additional 25 countries and should result in additional sales of up to $4 million per year, according to Medical Services International.

"Preliminary marketing in several of these countries shows that there is significant demand for an HIV test kit that is accurate and easy to use using whole blood," said MSI. "Testing throughout the world by health departments continues to show that the VScan HIV test kit fits this criteria."

Development accord with Chinese firm

Paradigm Medical Industries (Salt Lake City), a producer of ultrasound devices for the ophthalmic and medical industries, said it has signed a definitive agreement with MEDA Co. Ltd. (Tianjin, China) to jointly engineer and develop Paradigm's next generation of ultrasound and other medical products.

MEDA is one of China's leading developers and producers of ultrasound devices.

"We are pleased to be working with MEDA. Their engineering, research, and production capabilities are among the best in the world," said Paradigm Medical President and CEO Raymond Cannefax.

He said, "Initial ultrasound products have been received from MEDA and Paradigm has made initial sales of these devices in Europe. We expect all of our distributors worldwide to be carrying these products by mid-2006."

Cannefax said that after receiving U.S. and European regulatory approval in 2005 for its third-generation Ultrasound BioMicroscope (UBM), the P60, Paradigm "now [is] working with MEDA on the next-generation UBM as well as other new products and enhancement of our current devices."

He said that Paradigm Medical is presently the only company that manufactures and sells more than one UBM. "Upon completion of this new UBM project, the company will offer four Ultrasound BioMicroscopes for medical and research sciences applications."

Paradigm Medical expects to be manufacturing its products at both its facility in Salt Lake City and in Tianjin. "We expect to have a series of new, collaborative products on display at the AAO [American Academy of Ophthalmology] convention later this year," Cannefax said.