AccuTech, LLC, the personal
diagnostics company, announced today that it plans to offer FDA-approved
AccuMeter Theophylline test kits to global pharmaceutical and medical
markets. AccuMeter Theophylline is a patented, palm-size,
non-instrumented, disposable cassette test system that physicians use to
acquire accurate measurements of theophylline levels in asthma patients.
AccuMeter Theophylline is an in-office test, using fingerstick whole blood
or plasma as specimens, which can accurately measure inadequate or toxic
theophylline levels in 15 minutes. Physicians use resulting measurements to
provide proper treatment for the patient. Asthma patients on theophylline
therapy require frequent monitoring to achieve appropriate dosing and to
reduce adverse side effects.
The AccuMeter Theophylline test for accuracy, precision and specificity
compares comparably to standard laboratory testing systems such as the EMIT
and the Abbott TDX. Multi-center clinical trials showed excellent results
with the AccuMeter Theophylline test.
AccuTech holds 15 U.S. patents on the AccuMeter technology, which has
broad applications in both general chemistry and immunoassays. New products,
which AccuTech plans to introduce, include tests for HbA1c, fructosamine, TDM,
osteoporosis and cardiovascular disease markers.
Other highly successful
AccuTech products include CholesTrak (the first and only FDA-approved home
test kit for total cholesterol) and HDL cholesterol. Both products use the
patented AccuMeter technology.
AccuMeter Theophylline has received approvals from the Japanese
Ministry of Health and is reimbursed by the Japanese National Insurance
system. A prominent international distributor, Mr. Hattori, Managing Director
for Jokoh Co., feels that the AccuMeter Theophylline test will fulfill a
definite need in Japan.