A Medical Device Daily

SpectRx (Norcross, Georgia) reported that its contract with the National Institute on Alcohol Abuse and Alcoholism (NIAAA; Bethesda, Maryland) to develop a device to continuously monitor alcohol in the human body was increased by $900,000 and extended for another year. The value of the contract awarded to date is $3.2 million. An additional $500,000 may be awarded in 2007 at NIAAA's option, SpectRx said.

“The contract increase . . . is a further validation of our unique method of painlessly sensing the presence and level of substances in the body without drawing blood,” said Mark Samuels, SpectRx chairman and CEO. “Testing to date indicates that alcohol may be detected and its concentration levels continuously monitored using our interstitial fluid sampling (ISF) and sensor technology. In addition to sensing alcohol levels, we believe that our sensing technology may be applied as a platform technology to measure other biological analytes, such as glucose for diabetes.”

SpectRx coordinates the program and expects to receive about one-third of the additional funds. Childrens Hospital Los Angeles is the primary subcontractor.

The device is designed to detect alcohol abuse in critical job functions, such as airline pilots or in the criminal justice system. Results would be transmitted to a remote monitoring station.

Alcohol levels are currently measured by taking and analyzing a blood sample or through the use of a Breathalyzer, systems limited for certain applications because they can only take one measurement at a time and cannot track changes in bodily alcohol levels continuously over time.

The device under development tests for alcohol in ISF, a clear, water-like fluid that surrounds cells in the body. A laser painlessly creates four microscopic holes, or micropores, in the outer dead layer of skin through which a stream of ISF is drawn into a patch and tested for alcohol. The micropores are just slightly larger than a human hair and a feature of the laser allows the pores to penetrate only the outer layer of cells.

SpectRx is developing a sensor and has adapted its ISF acquisition technology for alcohol measurement. Childrens Hospital Los Angeles is developing the systems necessary for data processing, analysis and integration. If the R&D is successful, SpectRx will commercialize the device.

SpectRx develops solutions for insulin delivery and glucose monitoring, marketing the SimpleChoice line of diabetes management products, which include insulin pump disposable supplies. It also plans to develop a consumer device for continuous glucose monitoring.

The company also is commercializing a non-invasive cervical cancer detection technology through its subsidi-ary, Guided Therapeutics, which SpectRx will separate- ly finance.

In other grant news:Cyntellect (San Diego) said it will receive about $500,000 under a Phase IIB Small Business Innovative Research (SBIR) grant from the National Science Foundation (NSF) for continued development of its laser-based LEAP system for enhancing RNA interference (RNAi) applications. The grant will fund further development of the LEAP-enabled LaserFect technology for high-efficiency, low-toxicity delivery of siRNA into cells that are typically refractory to standard transfection techniques.

The Phase IIB grant program from NSF provides matching funds up to $500,000 to companies that meet goals of their Phase II grant and are able to secure additional non-governmental investments.

“This . . . funding directly recognizes the significant progress Cyntellect has made over the past year in developing and demonstrating the value of laser-based siRNA delivery,” said Dr. Fred Koller, president and chief technology officer.

Cyntellect's uses high-speed cell imaging and laser-based manipulation to develop products that enable cell imaging, purification and transfection capabilities to enhance the productivity of laboratory research, recombinant protein production, high-content cellular assays, functional genomics and proteomics and cell purification, including processing of cells for therapeutic transplantation.