A Diagnostics & Imaging Week

Iceland Genomics (IGC; Reykjavik, Iceland) and Roche Diagnostics (Basel, Switzerland) have entered into a cancer biomarker discovery collaboration aimed at developing diagnostic tests to predict recurrence of cancer.

The companies said they would jointly analyze patient samples to validate molecular markers for diagnostic tests to predict recurrence of cancer for selected tumor entities.

IGC said the agreement would give it access to certain gene expression data and support for further biological characterization of the patient samples in the company's BioBank in Iceland.

Financial terms of the agreement were not disclosed.

Dana Hosseini, CEO of the Iceland company, called the agreement "a significant opportunity for IGC. We look forward to working with Roche Diagnostics as a discovery partner to add significant value to our well-established BioBank and to further our knowledge of cancer."

Privately held Iceland Genomics said it uses a "clinical genomics" approach to understand the underlying mechanisms of cancer, isolate and characterize new therapeutic targets for cancer, assess the outcomes of specific therapies in genetically defined subcategories of cancer patients and optimize clinical trials.

The company was incorporated in Delaware in 1998. One of several genomics-based biotech companies operating in Iceland, it is the only one solely focused on cancer biology.

Another patent for IVMD

IVMD (Inverness, Scotland) said it has filed for a 12th patent for its medical diagnostic technology. It said the patent application is for the sensitive measurement of blood flow in tissue and includes the measurement of blood flow and concentration in skin and other body tissue through the non-invasive use of magnetic fields.

John Fuller, president and CEO, said the patent filing "is consistent with our strategy of patenting broad areas so that we can create a number of different products, each with large, global markets in the point-of-care arena."

He said the company's next steps will be to find "appropriate development partners to take this technology and create groundbreaking products."

Saying that blood flow and concentration "is an important consideration in many diseases," Fuller noted that skin blood flow testing already is in use for some allergies and mental health conditions. "In these cases," he said, "a reagent, applied to the skin, causes a blood flow change dependent upon sensitivity to a particular condition. Until now it was only possible to measure this visually, or with expensive Doppler ultrasound or laser measurement techniques. Hence the measurement is either very imprecise or prohibitively expensive to obtain."

He said that IVMD envisions that devices developed from this patent can provide specific outputs and be substantially less expensive and easier to use. "This can result in products that will be suitable for point-of-care use for a much larger patient population," Fuller said.

One example of the potential diagnostic use of this technology could be in the much earlier and accurate detection of schizophrenia, he said. With the prevalence rate for schizophrenia reported to be about 1.1% of the population 18 years or older, he said this means that at any one time as many as 51 million people worldwide suffer from schizophrenia.

IVMD consists of two wholly owned subsidiaries based in the UK IVMD (UK) Ltd. and Jopejo Ltd. IVMD (UK) is in the final stage of its first medical device for the cardiovascular market. Other medical conditions being addressed by its patented technology include the diabetes market and other areas where imaging is essential.

BSP reports HyperQ FDA-cleared

BSP Biological Signal Processing (Tel Aviv) reported receiving FDA approval for the marketing and sale of its HyperQ System.

BSP, a pioneer in the field of high-frequency ECG (HF ECG), has developed an ECG technology that it describes as having "breakthrough diagnostic value" for detecting and monitoring ischemic heart diseases (IHD) the leading cause of death in the developed world.

BSP's HyperQ System is a PC-based stress ECG device that records, analyzes and displays both conventional stress ECG and HF ECG for detection of myocardial ischemia.

BSP says the system uses proprietary signal acquisition and signal processing technology with a "user-friendly interface," numerical readout of the results, and self-explanatory graphs to demonstrate changes in the high frequency components of the QRS complex.

BSP reported recently concluding a large-scale, 1,000-patient study, the results currently being developed for publication.

"Studies in animals and humans demonstrated a distinct pattern of decrease in the high-frequency QRS components during acute myocardial ischemia," said Dr. Irit Yaniv, vice president of clinical and business development for BSP. "Moreover, reperfusion yielded the opposite pattern, suggesting that the HyperQ technology offers a great potential in detecting ischemic conditions and reperfusion success with unmatched accuracy."

Dr. Amir Beker, BSP's CEO and founder, said, "BSP's first FDA approval is an exciting and essential milestone in the road to global recognition of our technology. Together with the already received European ISO and CE certificates, it enables the introduction of our products to the U.S. and European markets."

BSP said that it also is developing products that include rest and monitoring systems, telemedicine devices and application for implantable cardiac devices.

Founded in 2000, BSP describes its team as consisting of "top signal processing experts, biomedical engineers and clinicians."