Toumaz Technology (Milton Park, UK) reported that it has signed a licensing and product development agreement in early December with an unnamed U.S.-based “strategic partner” — described only as a “leading global medical device business” — for proprietary signal-processing technology for handheld and body worn wireless diagnostic and monitoring products.

Company sources told Diagnostics & Imaging Week that additional information, including the partner’s identity, will be reported sometime next month.

DI&W learned that product development teams for the unnamed strategic partner and Toumaz are currently joined up in California, planning next-generation monitoring products that will be disposable, non-invasive and capable of providing real time critical vital sign information.

The joint announcement with the partner organization said the intention of the strategic alliance is to create new markets worldwide with the objective of becoming the global leader for personal health-monitoring products that “provide highly functional, robust, low cost, disposable and non-intrusive monitors for a wide range of healthcare and lifestyle management applications.”

Toumaz’s AMx processing technology for ultra-low-power signaling between the personal monitoring device and a receiving device, such as a telephone, laptop computers or wall-mounted detectors, uses neither Bluetooth nor conventional radio frequency identification technologies.

The strategic partner will immediately provide Toumaz with funding and then continue to provide funding and resources to advance product development. The partner also agreed to fund any necessary regulatory approvals. In exchange, the partner firm secures exclusive worldwide rights to manufacturing, product marketing, sales and distribution.

Toumaz will retain all the background intellectual property relating to its Sensium platform that integrates system-on-chip vital sign data processing with the AMx technology and will be entitled to explore further revenue streams for the technology outside of the applications used by the strategic alliance.

The UK firm is a wholly owned subsidiary of Nanoscience (Geneva, Switzerland), an investment group that for seven years has funded the research and development of the technology.

Nanoscience said in the announcement that the vital sign-monitoring market currently exceeds $1.5 billion and will see vigorous growth. Nanoscience also notes the point of care diagnostics market worldwide is estimated at $10 billion and growing.

The Sensium technology platform draws from 10 to 100 times less power than conventional digital processing based on software, depending on the sensor being used, whether for heart, motion or temperature. The Sensium signal can be detected up to 30 feet. An onboard memory chip can store vital signs data for short periods when the patient moves out of range.

In mid-November in London, Toumaz demonstrated a prototype product for its system-on-chip called Connected Freedom, a series of bandage-mounted sensors, called “plasters” in the UK, that continuously and remotely sends multiple vital signs including heart rate, body temperature and respiration.

Ultra-low-power consumption creates a competitive advantage in the market as battery size is substantially reduced, and thus the weight, and the autonomy of the medical device is extended.

In a demonstration at the World of Health IT in Vienna in early November, Toumaz showed a temperature-monitoring device powered by a slip of black paper, called PowerPaper, which is capable of transmitting body temperature readings every 10 minutes for one year.

More power-intensive applications, such as continuous ECG monitoring, requires a commercially available hearing-aid battery.

UK stroke strategy adds £105M for awareness

Under a plan to revolutionize stroke services in the UK unveiled this week by Health Secretary Alan Johnson, anyone in a higher-risk group who suffers a minor stroke will receive an MRI scan within 24 hours.

The strategy aims to accelerate the emergency response to stroke by setting out a framework for care for those affected by stroke and raising awareness about symptoms and risk factors.

The government has committed £105 million to provide national support for improving stroke services.

By following the actions set out in the new strategy, National Health Service officials said up to 6,800 deaths and cases of disability could be avoided every year, and another 1,600 strokes could be averted through preventive work.

Key elements of the stroke program include:

• MRI scans for higher-risk individuals with transient ischemic attacks (TIA), so-called “minor strokes.” Those scans are to be done within 24 hours of the patient experiencing stroke symptoms, within seven days for low-risk individuals. Officials said this step alone could lead to an 80% reduction in the number of people who go on to have a full stroke. Currently, less than 35% of UK healthcare providers manage to treat TIA within seven days.

• Immediate transfer of those with suspected stroke to a specialist center offering immediate clinical assessment, scans and clot-busting drugs. The plan calls for all local areas to have 24/7 coverage by at least one specialist center.

• Those with stroke requiring urgent brain imaging are to be scanned within the next scan slot during normal working hours, and within 60 minutes out of hours.

• All individuals with stroke must spend the majority of their time in a stroke unit.

• People affected by stroke and their caregivers should have immediate access to high-quality rehabilitation and support from stroke-skilled services in hospital, and the specialist care should continue for as long as it is needed.

The UK has “made great strides with stroke, heart disease and cancer in recent years,” Johnson said. “However, despite the considerable gains in developing stroke units and falling mortality rates, there remains much to be done to bring stroke services in line with those for cancer and heart disease.”

Of the £105 million committed to improve stroke services, the development of acute and community demonstration sites to pioneer best practices will receive £77 million in funding.

Another £12 million will fund activities aimed at raising stroke awareness nationally, and £1 million will go to training for stroke consultants, nurses and allied health professionals, includes funding for an additional 30 stroke specialist physician training posts in 2008-2009.

Professor Roger Boyle, national clinical director for stroke and heart disease, said raising awareness of how to prevent stroke through healthy living is at the heart of the strategy. “We also need the public and health and social care professionals to recognize stroke symptoms more effectively. [With] only a three-hour window for the use of clot-busting drugs, this means acting fast.”

Two Cepheid MRSA and SA tests released

Cepheid (Sunnyvale, California) reported the release of Xpert MRSA/SA-Blood Cultures (BC) and Xpert MRSA/SA-Skin and Soft Tissue Infection (SSTI) tests under the European Directive on In Vitro Diagnostic Medical Devices.

The company said the tests are designed to enable simultaneous rapid detection of two leading causes of hospital and community acquired infections – methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) — directly from blood cultures and soft tissue infection samples, respectively.

“The incidence of both hospital- and community-acquired MRSA and SA infections [has] been shown to be rapidly increasing,” said CEO John Bishop “We believe that the unique ability of the GeneXpert System to provide test results on an on-demand basis in a short period of time may significantly aid in patient management.”

Both the Xpert MRSA/SA-SSTI and Xpert MRSA/SA-BC products deliver results in about 50 minutes, enabling healthcare professionals to rapidly determine the presence or absence of MRSA and SA with a single test. In addition, both products use a multiplex molecular protocol for potentially avoiding clinical false-positive MRSA results.

“Staphylococcus aureus is a major cause of bloodstream infection, associated with substantial mortality and healthcare cost,” said Professor Marc Struelens of Catholic University Hospital (Brussels) and head of the Belgian Staphylococcal Reference Laboratory. “By analyzing positive blood cultures, we found the Xpert MRSA/SA test to be very reliable for rapid DNA-based detection and identification of S. aureus and MRSA bacteremia.”

F&S sees growth in POC hemotology offerings

The laboratory remains the primary site of hematology tests in Europe due to confidence in established methods of diagnosis, Frost & Sullivan (F&S; London) says in a new report. But it goes on to say that the rising awareness of the benefits of point-of-care- (POC) based of hematology diagnostics will boost uptake in that competing sector.

A new report from F&S, “European Hematology Diagnostics Market,” finds that the market had revenues of $698.8 million in 2006, expected to reach $943.4 million in 2013.

“The expansion of the POC hemoglobin market is inhibited by the preference for laboratory-based tests, [but] there are several factors that ensure that the hematology market continues to grow,” says F&S Research Analyst Gayathry Ramachandran.

Key market participants are developing automated analyzers that will enable laboratories to accelerate throughput. Therefore, the trend in this mature market is projected to be toward the laboratory segment, with laboratories making the most significant contribution to overall market revenues.

POC tests are slowly being preferred in some regions of Europe, as they generate quick results and assist physicians in identifying optimal treatments. Together, these trends are reinforcing overall market growth.

However, F&S said the reliance of physicians on tried-and-tested hematology tests is restricting the use of new test markers. Another challenge relates to the loyalty of laboratories toward particular manufacturers, which posed a significant for market entrants.

“The centralization of laboratories in Europe is minimizing revenue growth,” said Ramachandran. “The end-user base is very narrow – hospitals are the primary site for laboratory analyzers, while emergency units and intensive care units are the principal end-users of POC hematology analyzers – thereby restricting market growth.”

F&S said automation of analyzers will help reduce labor costs and sustain market expansion.