Inside The Industry: Biomedical Technology

June 14, 2004
Engineering Advances Fuel Advanced Health-Care Products

Miniaturized electronics and advanced fluidics are profoundly affecting the biotech and biomedical industries. Ten years ago, new diagnostic test equipment was designed around a complex robot and an elaborate fluidic system. Yards of plastic tubing snaked through a 500-pound machine requiring compressed gas, plumbed-in water, and a live-in service technician. But that's all changed.

I-STAT's fast, handheld blood chemistry analyzer revolutionized the point-of-care market about 10 years ago. About the size of a pocket calculator, it accepts a matchbook-size, disposable, plastic fluidic cartridge that contains silicon sensor chips with ion-sensitive transistors. After adding a drop of blood, the cartridge is inserted into the miniaturized instrument. The instrument automatically calibrates the sensors, passes the blood over the sensor chips, and quantifies the levels of up to eight different chemicals in only two minutes.

The A1cNow from Metrika is the size of a pack of Tic Tacs. Inside is a battery, LCD display, circuit board, and a sophisticated, high-precision optical system. It turns itself on when a drop of blood is applied, draws the blood into the optical system, and quantifies the concentration of hbA1c. This chemical indicates how well diabetics manage their disease. The single-use device costs about $20.

And, Cepheid's GeneXpert rapidly detects infectious bacterial or viral organisms or cancer with extreme sensitivity. This desktop device accepts a small, disposable microfluidic cartridge. Raw biological specimens such as blood, tissue, sputum, and urine are inserted into the cartridge, which automatically performs the highly complex chemical operations required to extract and concentrate nucleic acids from such specimens. The target DNA (if present in the sample) is then chemically amplified and detected in a miniature fluorescent optical system. The entire operation takes about 35 minutes. It replaces methods, such as culturing, that can take several days. This system forms the heart of biological detection systems now being deployed across the U.S. Postal Service to detect anthrax in mail-sorting machines.

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