SBIR-STTR Award

Theophylline is a drug currently used by most asthmatic/allergic adults an children, constituting over six million patients. Therapy requires frequent monitoring of theophylline levels in blood as it causes toxicity at concentrations higher than 20 mg/L and is ineffective at lower than 10 mg/L. Current testing is done in hospital/commercial laboratories at a cost of $27.00 per test to Medicare/Medicaid. There is great need for a cost effective, easy to perform test for theophylline so that physicians, in their offices, or patients can quickly monitor this drug by using a drop of whole blood from a finger tip.Current tests for theophylline use antigen-antibody technology and are cumbersome and expensive. Alternatively, GDS Technology's discovery of a new enzyme, namely Theophylline Oxidase, which selectively oxidizes theophylline could enable the development of a simple, convenient, and specific enzymatic test. This proposal (Phase I) focuses on initial feasibility studies and will include studying the properties of this enzym to establish its suitability for a commercial test. The goal of Phase II will be the development of a convenient enzymatic dry chemistry test for theophylline which will cost $1.00-2.00 and thus will greatly reduce healt care cost.National Institute of Allergy and Infectious Diseases (NIAID)

Theophylline, a drug used by 6-10 million patients, needs to be monitored closely in blood for effective management of asthmatic, allergic, and other bronchospastic conditions. Current tests for theophylline are based on expensive antigen-antibody technologies. Health insurance reimbursements for such measurements is between $27.00 and $37.00 per test. Alternatively, GDS Technology has discovered a unique enzyme, Theophylline oxidase, which selectively oxidizes theophylline in the presence of various electron acceptors (patents pending). Phase I research has clearly established that Theophylline oxidase is suitable for use in a stable liquid phase reagent test for measuring theophylline in serum (already an FDA approved test) and has potential for use in a new dry strip-test format. Phase II research will involve l) incorporation of an appropriate electron acceptor dye (found in Phase I study) along with Theophylline oxidase in a dry strip-test configuration, 2) development of a low cost reflectance meter, 3) pilot scale production of the strip-test, and 4) preliminary clinical evaluation of the new test. It is anticipated that this research could yield a suitable method for "on-site" testing of theophylline in whole blood. The test will yield accurate results and will sell for less than $2.00/test, thus providing quality health care at a significantly reduced cost.