A Diagnostics & Imaging Week

VivoMetrics (Ventura, California), developer of the LifeShirt – described as "the first real-time physiologic monitoring system" – has partnered with RAE Systems (San Jose, California) to integrate the LifeShirt 300 with the AreaRAE wireless networks.

The partnership brings together responder life-sign data and environmental hazardous material detection in real-time, on the same incident command display. That is expected to "contribute significantly" to increased safety for both first responders and the people they protect, the companies said.

Specifically designed for first responders, hazmat workers, firefighters and military personnel, the LifeShirt 300 is a lightweight chest strap that monitors breath rate, heart rate, activity, posture and skin temperature continuously and in real-time.

The AreaRAE Network System detects hazardous gases and radiation in the environment giving incident commanders instantaneous information to respond accordingly.

Data collected by the LifeShirt will transmitted in real-time using a RAELink2 wireless modem to a remote command center up to two miles away, where first responders and their working conditions are monitored. Real-time information is displayed using ProRAE Remote, PC-based software that continuously displays sensor and physiological data, enabling commanders to intervene if first responders appear to be in danger. ProRAE Remote also supports individual alarms based on each responder's physical fitness.

StatSure Diagnostic Systems (Framingham, Massachusetts) said it has signed a binding term sheet with Inverness Medical Innovations (IMI; Waltham, Massachusetts) to develop and market consumer diagnostic products for HIV using StatSure's "barrel" technology.

The companies said this collaboration will utilize Inverness' leadership in marketing and distributing rapid diagnostic tests throughout the world.

StatSure has developed a technology platform for screening for the presence of antibodies to certain infectious diseases. IMI will receive an exclusive worldwide license for all consumer markets and a non-exclusive license to market the HIV barrel product to the professional markets. StatSure will be responsible for completing the development and for manufacturing the product, as well as for performing clinical trials in cooperation with IMI and obtaining regulatory approvals for sales in both the professional and consumer markets.

StatSure's barrel technology, marketed under the name StatSure, is a self-contained, rapid whole-blood testing format for the detection of antibodies to a broad spectrum of infectious diseases. The sample is obtained though a small (~3 microliters) fingerstick. Results can often be read within several minutes and do not require any instrumentation. This product line is designed for on-site testing in clinics, doctors' offices, the military, mobile health vans, emergency situations and those places where immediate results are necessary.

In other agreements:

• Illumina (San Diego) reported that it has expanded the scope of its multi-year, genotyping services agreement with GlaxoSmithKline (GSK; London).

Illumina will begin to use Sentrix HumanHap550 BeadChips for a series of whole-genome association studies for GSK. The first such study involves genotyping a collection of 2,000 case and control DNA samples provided by GSK for a specific disease, detail for which was not provided.

Illumina's HumanHap BeadChips provide "broad genomic coverage" and the "highest per-marker information content of any whole-genome genotyping arrays," the company said. The efficient coverage is made possible by Illumina's Infinium assay, which enables "intelligent" selection and array-based interrogation of virtually any SNP (single nucleotide polymorphism) in the human genome.

• Medicomp (Melbourne, Florida), a subsidiary of United Therapeutics that specializes in providing cardiac telemedicine services throughout the U.S., reported that it has been awarded a contract to sell ambulatory Holter monitoring systems through Premier Purchasing Partners (San Diego).

Medicomp's Decipher Holter Monitor is designed with an on- board artificial intelligence algorithm, Diogenes, making it capable of detecting a variety of different arrhythmias while on the patient, the company said. As a testament to its quality, Decipher was the only Holter monitor to pass all the rigorous tests required to monitor the crew of the International Space Station as they live and work in outer space, the company said.

• NeuroMetrix (Waltham, Massachusetts), focused on the development of products used to diagnose neuropathies, including diabetic peripheral neuropathy, has signed a mutually exclusive agreement with Parlex (Methuen, Massachusetts), a division of Johnson Electric, for the manufacturing of biosensors sold by NeuroMetrix.

Shai Gozani, MD, PhD, president and CEO, said, "Parlex has been the sole manufacturer of our biosensors since the launch of the NC-stat System in 1999. . . . This agreement formalizes what has been a very successful collaboration between our companies and we look forward to further leveraging this relationship as we expand our business."

The NC-stat System, the company's neuropathy diagnostic system, has been on the market since May 1999 and is used in over 4,000 physician's offices and clinics in the U.S. The company holds utility patents covering a number of important aspects of the NC-stat System.

• Nanogen (San Diego), a developer of advanced diagnostic products, and Fisher Scientific (Hampton, New Hampshire) said they have expanded their relationship to include an R&D collaboration in molecular diagnostics. The collaboration agreement complements Fisher's equity investment in Nanogen, reported in March.

The companies will share technology and patent rights specifically for the development, manufacture and marketing of new molecular diagnostic products.

Fisher Scientific may provide up to $10 million in total during 2007 and 2008 for the R&D of infectious disease and molecular diagnostic tests that will be mutually agreed upon. The extensive knowledge, intellectual property and capabilities of both companies will enable molecular diagnostic products to be brought to the market more quickly.

Additionally, Nanogen and Athena Diagnostics, a wholly owned subsidiary of Fisher Scientific, have agreed to develop products based on Athena's proprietary biomarkers for research and for in vitro diagnostic use.

Athena has a portfolio of markers in the fields of neurology and endocrinology that it has incorporated into its testing service, several of which could be incorporated into assays for use on Nanogen's microarray platform, the NanoChip400. Nanogen likewise has access to a wide range of markers that could be used to create unique tests for the Athena Diagnostics testing service.

• StatSure Diagnostic Systems (Framingham, Massachusetts) said it has signed a binding term sheet with Inverness Medical Innovations (Waltham, Massachusetts) to develop consumer diagnostic products for HIV using StatSure's "barrel" technology.

That technology, marketed under the name StatSure, is a rapid whole-blood testing format for the detection of antibodies to a spectrum of infectious diseases. The sample is obtained though a small fingerstick, with results often available within several minutes and not requiring any instrumentation.

IMA will receive an exclusive worldwide license for all consumer markets and a non-exclusive license to market the HIV barrel product to the professional markets.

StatSure will be responsible for completing the development and for manufacturing the product, as well as for performing clinical trials in cooperation with Inverness and obtaining regulatory approvals for sales in both the professional and consumer markets.

• US Oncology (Houston), a national cancer treatment and research network, has entered into a venture with the Molecular Profiling Institute (Phoenix) to create the Tissue Banking and Analysis Center (TBAC).

While serving a variety of research, pharmaceutical and diagnostic clients, TBAC will handle the large volume of bio-specimen collection and analytical services for US Oncology. TBAC, in collaboration with US Oncology and AmeriPath (Palm Beach Gardens, Florida), a network of pathologists engaged in cancer diagnosis, will provide access to tissue samples, clinical trial design, biomarker development and esoteric testing under the guidance of top scientists from government and industry.