A Diagnostics & Imaging Week

In Veritas Medical Diagnostics (IVMD; Inverness, Scotland) reported signing a commercial agreement on a joint project with the Ness Foundation, a Scottish-based neuro-developmental research organization.

IVMD said it would apply its low-cost measurement systems together with the foundation's intellectual property to develop a rapid, non-invasive diagnostic product for the early detection of mental illness.

The company said the joint development would focus in the area of phospholipid spectrum disorders and the breakdown in communication between brain cells to evaluate simple, quantitative and diagnostic tests.

John Fuller, president and CEO of In Veritas, said, "Our technology is already proven to measure blood parameters and was the subject of a recent patent application for non-invasive measurement. There is tremendous synergy between our measurement techniques and the type of diagnosis required by the scientists at the Ness Foundation."

Ness Foundation Chairman Douglas Mundie said, "We hope that by using IVMD's technology with our own intellectual property, we can further the understanding and effective treatment of neuro-developmental disorders."

In Veritas, known as In Vivo Medical Diagnostics prior to a name change earlier this spring, said the process currently in use is imprecise, requires skilled interpretation and is costly, preventing any widespread use. It has been estimated that one in six people worldwide will suffer from a medically identified neuro-developmental illness with one in 100 having a serious condition.

World Health Organization (Geneva, Switzerland) statistics show 24 million people worldwide suffer from schizophrenia (0.7% of the adult population) and the cost of treatment alone is $1.44 billion per year.

The Ness Foundation's mission is to improve the quality of life of individuals with neuro-developmental disorders and other related conditions, by conducting research to discover safer, more effective diagnostics and treatments. The conditions that its research is focused on include schizophrenia, bipolar disorder, autism spectrum disorder, dyspraxia, dyslexia, depression and ADHD.

In Veritas Medical Diagnostics consists of two wholly owned subsidiaries based in the UK — IVMD (UK) Ltd. and Jopejo Ltd.

Ukraine approval for VScan test kits

Medical Services International (MSI; Edmonton, Alberta) said it has received regulatory approval to sell its VScan HIV test kits in the Ukraine. The company said market studies show that it should expect to sell in excess of 750,000 HIV test kits in that country in the first year.

In addition to the Ukraine approval, MSI said it anticipates receiving additional approvals in several surrounding countries. The company said it has applied for regulatory approval of its VScan kits in eight eastern European countries, and is in negotiation with distributors in all eight countries. MSI said its market studies show that there will be a "significant demand" for the test kits, with the expectation that it will supply in excess of 4 million test kits into the region within a year.

The company said that most of the rapid test kits for detection of HIV currently used in this region are based on the identification of the IgG antibody, "which does not show up until 90 to 120 days after infection. By then the immune system has been seriously compromised."

The VScan test kit detects HIV exposure upon the formation of any of the antibodies (IgM, IgA, IgD or IgG). The first three antibodies all form before IgG, according to the company. The first antibody that forms after the infection of HIV is IgM, which Medical Services International said is detectable at the earliest stages (two to 11 days) of viral infection. It said that the VScan rapid test kit detects the IgM antibody, "making it much more sensitive and specific to the detection of the HIV infection than any other HIV test kit on the market."

Uganda institute backs Calypte tests

Calypte Biomedical (Pleasanton, California) said that the HIV/AIDS Reference and Quality Assurance Laboratory at the Uganda Virus Research Institute (Entebbe, Uganda) has issued a recommendation that the Uganda National Drug Authority grant approval for the importation of the Calypte rapid HIV 1/2 Antibody Tests using blood, oral fluid and urine as a specimen.

The Calypte assays were assessed during a prospective study that evaluated about 350 subjects and were performed at the Uganda Virus Research Institute. The Calypte Aware (BSP), Aware (U) and Aware (OMT) each were deemed satisfactory for assay accuracy and operational qualities as compared with a standard HIV 1/2 test algorithm.

The evaluation report added: "There is yet to be another rapid urine test with performance similar or superior to the Aware (U) from Calypte Biomedical."

Dr. J. Richard George, president and CEO of Calypte, said, "This is the first regulatory approval that we have received for our rapid HIV testing platform and believe that it will be the first of many. We ... are currently in the process of finalizing an agreement with our distributor in this territory."

As of the end of 2003, it was estimated that about 530,000 adults and children in Uganda were living with HIV/AIDS.

Ex-Im Bank guarantee backs Turkish sale

Exporter Marubeni America (San Francisco) is using a $13.7 million loan guarantee from the Export-Import Bank of the United States (Ex-Im Bank) to sell oncology medical equipment supplied by U.S. suppliers to Hacettepe Universitesi, a leading Turkish hospital located in Ankara.

Suppliers on the export sale include GE Healthcare (Waukesha, Wisconsin), Aras USA (Lyndhurst, New Jersey), Varian Medical Systems (Palo Alto, California), Hill-Rom (Batesville, Indiana), Beckman Coulter (Fullerton, California), Fischer Imaging (Denver) and Steris (Mentor, Ohio).

The Turkish hospital will use the linear accelerator, computerized tomography scanners, magnetic resonance imaging and other equipment to upgrade and expand its oncology facilities.