MICROALBUMIN URINE DIPSTICK GETS CLIA WAIVER FROM FDA.

Diagnostic Chemicals Limited (DCL), Oxford, Conn., has been notified by the U.S. Food and Drug Administration that its new ImmunoDip(R) microalbumin urine dipstick test has received waived status under the Clinical Laboratory Improvement Act of 1988 (CLIA).

ImmunoDip is the easiest way to identify the diabetic or hypertensive patient who is exhibiting early signs of kidney disease (nephropathy). Early detection of microalbuminuria (slightly elevated quantities of protein in urine) before the appearance of overt symptoms of kidney disease alerts the physician to the need for immediate patient intervention and affords the opportunity, through treatment, to slow down the inevitable progression of the disease. Controlling this disease has been shown to significantly delay the need for dialysis treatment thereby reducing both physical and financial stress on the patient. The American Diabetes Association recommends annual dipstick screening for microalbuminuria in all high-risk patients, with positive results confirmed by more specific methods. And now, with CLIA Waiver categorization, ImmunoDip will be available to the more than 170,000 CLIA registered laboratories in the U.S., including over 95,000 physician office laboratories.

"ImmunoDip incorporates the simplicity of a urine dipstick test with the accuracy and reliability of monoclonal antibody technology," said David Templeton, CEO. "Nurse friendly features such as patented self-sampling and self-timing innovations allow the nurse to simply place ImmunoDip into a urine sample, walk away and after 3 minutes return to read the results like a pregnancy test. The nurse no longer has to worry about dipping to a particular depth or timing how long the urine has been in contact with the test strip."

The ImmunoDip microalbumin test which was awarded the Medical Design Excellence Award and is covered by two patents is packaged in boxes of 25 individually foil sealed tests. The product is stored at room temperature and with built-in control features provides absolute confidence in every test result. The sensitivity of this test has been shown to be 98% with a specificity of 98%.

Diagnostic Chemicals Limited (DCL) is a privately held company, headquartered in Prince Edward Island, Canada with subsidiary companies in Oxford, Connecticut and Mexico City, Mexico. Over a span of 30 years DCL, an ISO 9001 registered company, has developed, manufactured and sold various innovative diagnostic reagents and other diagnostic test devices.

For additional information, call 203/881-2020 or visit http://www.dclchem.com.