A Diagnostics & Imaging Week

The European Union, through the Sixth Framework Program, has approved a project led by IDIBAPS-Hospital Clinic, with the aim to validate the IBDchip (Inflammatory Bowel Disease DNA Chip) within the European Community

It is said to be the world's first diagnostic DNA chip, and has the main object to predict prognosis and response to therapy of patients suffering from inflammatory bowel disease. The program has a EUR 2.5 million budget for the next three years for conducting several studies, including a total of 3,000 to 4,000 patients in seven European countries.

A consortium that includes seven European centers in inflammatory diseases and genetics; an enterprise with the technology for manufacturing the chip; and an enterprise in laser technology, in charge of optimizing the reading of the chips, has been created for conducting this project.

The consortium is coordinated by Dr. Miquel Sans, researcher of the IDIBAPS Physiopathology of Gastrointestinal Lesions Group and member of the gastroenterology facility of Hospital Clinic de Barcelona.

The IBDchip was developed by the Basque company Progenika Biopharma in collaboration with Sans. The chip is a simple device requiring only a small blood sample. The DNA is obtained from this sample, which is placed in a glass support (the IBDchip) for the detection of 61 mutations using laser technology.

Crohn's disease and colitis ulcerosa are heterogenic pathologies with unpredictable clinical course and drug response, and the prevalence of these diseases has significantly increased in developed countries. In Spain, more than 100,000 people are affected, and the incidence of the disease is 15 to 20 new cases per 100,000 inhabitants annually. The number of patients in Europe is estimated to be 1.5 million.

About 15% of patients have at least one relative suffering from one of these pathologies, which involve an important loss of quality of life. The treatment costs are of EUR 7,382 a year per patient, a total cost of EUR 1 billion a year for public healthcare.

The analysis of the first Spanish IBDchip Study aiming to predict the clinical course of Spanish intestinal bowel disease patients is being conducted. This work, also led by Sans, includes more than 900 patients.

Definitive analysis of the first and second phases of the study is expected within the next two months. The final results will determine the exact usefulness of the IBDchip in Spanish patients.

The new European project also aims to study the European usefulness of the tool. "This step is indispensable due to the fact that there is a large genetic variability among the several geographic areas and ethnic groups of our continent, and the mathematical prediction models resulting from the European study will probably be different from those obtained in Spain,"IDIBAPS said.

One of the first aims of the European IBDchip Project is to identify new genetic factors regarding intestinal bowel disease. The IBDchip's version that will be used in such studies is likely to include more than 200 genetic factors instead of the 61 of the first-phase IBDchip.

Pact on nanomechanical sensors

Researchers from the National Center of Competence in Research at the newly established Swiss Nanoscience Institute (SNI; Basel), together with scientists at Roche (also Basel), have developed a method for the rapid detection of disease- and treatment-relevant genes. The results of this research were published in the December issue of the journal Nature Nanotechnology.

Ulrich Certa, head of functional genomics at the Roche Center for Medical Genomics, said, "Our research results show that these new nanomechanical sensors can be used for the direct and continuous monitoring of patients' response to a given treatment. This promising new technology takes us a step nearer to tailoring treatment directly to patients' needs, hopefully with ever fewer adverse effects."

The new method detects active genes by measuring their transcripts (messenger ribonucleic acid [mRNA]), which represent the intermediate step and link to protein synthesis. Short complementary nucleic acid segments (sensors) are attached to tiny silicon cantilevers that are only 450 nanometers thick and thus react with great sensitivity. The researchers said binding of the targeted gene transcript to its matching counterpart on one of the cantilevers results in optically measurable mechanical bending.

In the Nature Nanotechnology paper, the researchers cite the example of a tumor cell line in which interferon treatment activates a gene for controlling cell growth to show that this nanomechanical method can be used for rapid gene transcript detection. Being so sensitive, this new type of nanomechanical sensor has no need to label or copy the target molecules, thus greatly increasing measurement precision.

Because the method also works within minutes, the researchers said it could be used as a real-time sensor for continuously monitoring biomedical processes. An array of different gene transcripts can even be measured in parallel by aligning appropriately coated cantilevers alongside each other.

The new method complements current techniques such as the gene chip and real-time polymerase chain reaction (PCR) and could be used as a real-time sensor for continuously monitoring various clinical parameters or for detecting rapidly replicating pathogens that make prompt diagnosis essential.

EOS, KaVo Dental in distribution pact

Electro-Optical Sciences (EOS; Irvington, New York) has signed a licensing agreement with KaVo Dental (Biberach, Germany), a dental equipment manufacturer, to develop and commercialize Difoti, an FDA-cleared non-invasive imaging device developed by EOS for the detection of dental caries.

KaVo will pay EOS an undisclosed up-front sum as well as up to a double-digit royalty based on the number of systems sold annually. KaVo said it has made "a multimillion-dollar commitment"to refine the Difoti product for commercial launch.

EOS is focused on developing a noninvasive, point-of-care instrument to assist in the early diagnosis of melanoma. Its flagship product, MelaFind, is a hand-held imaging device that emits multiple wavelengths of light to capture images of suspicious pigmented skin lesions and extract data. The data are then analyzed against EOS's database of melanomas and benign lesions using sophisticated algorithms in order to provide information to the physician and produce a recommendation of whether the lesion should be biopsied.

KaVo has developed products in the areas of prophylactic, minimal invasive and aesthetic dentistry, serving dentists and dental labs.