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Executive Summary

MILES THEOPHYLLINE MONITORING TEST FOR MD OFFICE USE will allow physicians to better tailor drug dosage regimens to individual patients, the firm pointed out in a March 27 press release announcing approval of the test. "In the absence of in-office drug monitoring capabilities, most doctors have been prescribing standard medication doses that are safe for everyone," Ames Div. President Richard Falb. PhD, asserted in the release. "Such standard doses often are not enough to optimally control the disease in many patients." The new test "will enable doctors to routinely monitor how much of the Rx actually reached the patient's blood-stream and to optimize dosage levels accordingly." The theophylline monitoring test, which is designed for use exclusively with Miles' Seralyzer bench top analyzer, is the first drug monitoring test aimed at the physician's office market, according to the firm. Additional tests for drugs such as phenobarbital and phenytoin are in the final stages of development. Better theophylline dosing could save "millions of dollars annually" in emergency room and hospital costs, Miles maintained. The firm cited a study published in the Annals of Allergy which estimated that "as many as 50% of patients on standard doses of theophylline may be underdosed and subject to asthma attacks. Another 10% to 20% may be overdosed and at risk of toxicity." Developed by Ames, the test received clearance from FDA's Center for Devices & Radiological Health through the abbreviated 510(k) process. The test was determined by FDA to have "substantial equivalence" to other marketed theophylline monitoring tests. The theophylline test will be launched in April. The monoclonal antibody-based test employes Ames' "dry" reagent technology and will be marketed in strip form. The seralyzer's turnaround time for the test is about four minutes, Miles said. According to the firm, the Seralyzer is the first in-office system to perform both routine blood testing and drug monitoring. Since is introduction two years ago, about 2,000 systems have been installed.

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