A Diagnostics & Imaging Week

Shimadzu (Tokyo) and Third Wave Technologies (Madison, Wisconsin) reported that the companies have signed an agreement for the development and commercialization of a point-of-care instrument that could bring molecular diagnostics to the doctor's office.

The new instrument is roughly the size of a desktop computer and is expected to be the world's first fully automated system for nucleic acid analysis that can easily be used at the point of care, the companies said.

It is capable of analyzing a patient's DNA for specific gene sequences from a drop of whole blood in approximately 90 minutes. Shimadzu and Toppan developed the instrument in partnership with Dr. Yusuke Nakamura of the RIKEN Institute at the University of Tokyo, who the companies described as one of the world's foremost genetic researchers.

The instrument employs Nakamura's polymerase chain reaction, or PCR, multiplexing know-how, Shimadzu's AmpDirect reagents for performing PCR on whole blood, and Toppan's consumable chip platform. Under the agreement, the companies will apply Third Wave's Invader chemistry to the instrument for detection of variations in cytochrome P450 genes that can cause adverse drug reactions.

The companies said they anticipate commercializing a research-use-only version of the instrument before the end of this year.

Third Wave has exclusive marketing rights for the instrument in the U.S., Canada and Europe, and will determine the regulatory path in the U.S.

Shimadzu and Toppan have exclusive marketing rights for the rest of the world, while Third Wave will be the exclusive worldwide supplier of Invader reagents for the instrument.

Mediscience Technology (Cherry Hill, New Jersey) and Alfanix Technology (ATL) said they have entered into an alliance to construct photonics devices for cancer diagnostics, such as the Cancer Diagnostic Ratiometer (CD-R), and to introduce the devices into Latin America for testing on human subjects.

CD-Rs use light fluorescence to distinguish between cancerous and non-cancerous tissues to obtain a more accurate in situ optical PAP test. CD-R results are immediate, whereas diagnosis via conventional PAP smears takes approximately one week. While CD-Rs are seen as a supplement for conventional PAP smears initially, they may eventually serve as a substitute.

As part of the alliance, ATL will oversee the construction for Mediscience of CD-R Beta units for use in clinical testing.

At least two will be used for clinical tests in the Dominican Republic under the supervision of ATL; and at least two will be used for similar trials in the United States under the supervision of Mediscience. The objective is to obtain algorithms in order to evaluate and improve the efficacy of CD-Rs on human subjects.

"With a high index rate of GYN cancer among Latin America's female population, there is an urgent need for a more accurate approach to detect and diagnose the disease," the companies said.

In other agreements:

• Masimo (Irvine, California) reported signing a three-year, multi-source agreement with Premier (San Diego), a group purchasing organization for Masimo's SET pulse oximetry and Rainbow SET Pulse CO-Oximetry, including stand-alone monitoring devices, hand-helds and sensors.

Masimo is the inventor of read-through motion and low-perfusion pulse oximetry, a technology called Masimo SET, which, it said, has "proven more accurate and reliable in the most challenging clinical settings by over 100 independent clinical studies."

Masimo recently introduced Masimo Rainbow SET, a new technology that uses eight wavelengths of light enabling clinicians to capture and monitor an array of physiological data non-invasively. Rainbow SET will be available in Masimo monitors and in multi-parameter patient monitors produced by leading manufacturers.

The Rad-57 Pulse CO-Oximeter, the first FDA-cleared Rainbow SET product from Masimo, is a hand-held device that allows clinicians to detect and monitor carbon monoxide levels in the bloodstream non-invasively. In clinical studies and in the field, Rad-57 is already proving itself effective in detecting carbon monoxide poisoning in seconds, allowing accurate diagnosis and early treatment of a life-threatening problem that is frequently misdiagnosed as flu or migraine.

• Bayer HealthCare Diagnostics Division (Tarrytown, New York), a member of the Bayer Group (Leverkusen, Germany), reported a licensing agreement with Signet Laboratories (Dedham, Massachusetts) under which Signet will conduct research with immunoassays discovered by Bayer scientists that detect two markers of inflammation, uristatin and bikunin, found in blood and urine.

Signet plans to offer assays to investigators conducting research into the detection and management of acute and chronic diseases.

• Genetic Technologies (GTG; Melbourne, Australia) reported an alliance with MetaMorphix (MMI; Beltsville, Maryland), a developer of new genetic markers.

In 2004, MMI acquired a license to the GTG non-coding patents, and since then the two companies have pursued the development of new technologies with applications in human health and diagnostics and also in animal genetics and genomics.

GTG and MMI recently identified several overlapping interests and now will explore joint commercialization of these new opportunities, utilizing the intellectual property held by each. The companies said they also would explore ways to optimize the geographic advantage of GTG's testing lab and MMI's testing lab in Davis, California.

• Universal Detection Technology (UDTT; Los Angeles), a developer of early warning monitoring technologies to protect people from bioterrorism and other infectious health threats, reported that it has signed a joint development agreement with homeland security technology provider Michael Stapleton Associates (MSA; New York), to cooperate in an effort to enable UDTT's biothreat technologies to operate with MSA's SmartTech explosive detection and surveillance systems.

Michael Stapleton Associates' SmartTech technology is certified under the Department of Homeland Security's SAFETY act. SmartTech is a high-speed audio and video connection that allows a bomb technician located in New York to support a screening operation anywhere in North America and ultimately worldwide.

Whenever an image captured by the X-ray machine is beyond the scope of the operator they can, by clicking the SmartTech icon, transmit the image real time to the MSA SmartTech Operations Center. At the same time the image is transmitted, audio communication is established and the screener and expert can evaluate the image using all of the features of the machine at the direction of the MSA technician.

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