Technology Overview

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Painless Blood-Analyte Monitoring

Kumetrix was formed specifically to develop and commercialize minimally invasive biodiagnostic products based on silicon micro-needles and micro-probes similar in size to a human hair.  These needles/probes penetrate human skin reliably and painlessly, and can be used in instruments for single-use or continuous monitoring of analytes in blood.

Glucose self-testing by diabetics represents the largest single potential market. The pain and psychological trauma associated with the current self-testing method is significant.  As a result, many diabetics do not comply with the recommendations of a government study  (DCCT), which clearly established the compelling benefits of frequent testing. Kumetrix has designed a silicon-based "micro-needle" with a diameter smaller than that of a human hair, enabling diabetics to withdraw blood painlessly.

Currently available self-testing devices require patients to obtain a blood sample, usually from the finger, by puncturing the skin with a spring-loaded lancet. Patients apply a drop of blood to a test strip, which provides a reading, telling the patient how much insulin to take. Long-term use of this "finger stick" procedure produces calluses, thickening of the skin and loss of sensation in the fingers. Problems with the lancet technique are particularly acute for diabetic children and the elderly.

When commercialized, a blood-glucose monitor based on our micro-needle will permit diabetics to test their blood painlessly and neatly. Such a system will probably consist of a hand-held, battery-powered, electronic monitor—about the size of an audio cassette tape-- that accepts a cartridge loaded with disposable sampling devices. Each disposable consists of the micro-needle and a receptacle into which the blood sample is drawn.

To take a measurement, a patient will load the cartridge into the electronic monitor and simply press the monitor against the skin. This action will cause the micro-needle to penetrate the skin and draw a very small volume of blood ( less than 100 nanoliters ) into the disposable. Chemical reagents in the disposable react with the glucose in the blood to produce a color. The blood-glucose concentration will be measured either electrochemically or optically, and the resultant value displayed on the monitor.

The action of taking the blood sample is similar to that of a mosquito. The silicon micro-needle which penetrates the skin and draws the sample is similar in size to the proboscus of a mosquito (smaller in cross-section than a human hair), and is capable of painless blood sampling, as is also the case with the mosquito [see figure to right]. In the majority of mosquito bites, the target animal, human or otherwise, is unaware of being bitten. The mosquito uses various chemical agents to facilitate drawing blood without coagulation; it is these chemicals that cause the subsequent swelling, redness, and itching of a mosquito bite. The Kumetrix device does not require chemical agents to aid its operation.

Our  core technology is potentially applicable to many other medical markets, including neonatal, emergency room and acute care testing, as well as testing for pesticides or nerve gas exposure. The military doctrine regarding nerve agent exposure has changed considerably since the Gulf war and the subsequent terrorist attack in the Japanese subway system.  In both cases the casualty rate due to acute poisoning was very low. However,  many people continue to suffer illnesses related to chronic low level exposure of those nerve agents. Gulf War Syndrome and the terrorist incidents in Japan involving the nerve gas Sarin have generated interest in a hand-held, rapid-response instrument for detecting exposure levels.  The U.S. Army has expressed an interest in funding the development of this product.

Note: The silicon micro-needle is in development at this time.

 
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