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Press Release

The BTA stat ®TEST RECEIVES FDA CLEARANCE FOR PRESCRIPTION HOME USE

The BTA stat test becomes the first tumor marker test to be cleared by the FDA for prescription home use. The test detects bladder tumor associated antigen in the urine of persons undergoing monitoring for recurrent bladder cancer.

Cortlandt Manor, NY - March 13, 2000  The BTA stat test, manufactured by B.D.S., Inc., (ISO 9001) Redmond, WA, recently received FDA clearance. The test is now available by prescription for home use to detect recurrent bladder cancer as an aid in the management of bladder cancer patients. This historic clearance for a tumor marker assay marks the second clearance for the BTA stat test, which was previously cleared for laboratory use.

The BTA stat test is a single step rapid immunoassay, which requires 5 drops of urine and provides results in 5 minutes. The appearance of a line in the patient window indicates a positive result. The BTA stat test requires a single voided urine sample with no sample treatment or preparation. The BTA stat device is supplied in an individual foil pouch, with a plastic dropper, and can be stored at room temperature (60 to 850 F).

The BTA stat Test is a one-step, rapid immunochromatographic qualitative assay cleared for physician’s office and prescription home use. Various studies have reported equal or better sensitivity than cytology in all bladder tumor groups; such as 83% vs 40%, and 65% vs 33%, respectively. The specificity of the BTA stat Test has also been reported to be very high, such as 72% in patients with benign genitourinary disease and 95% and 98% in healthy volunteers. Overall specificity of the BTA stat Test was found to be less than cytology, 85% and 99%, respectively. In two recent studies, the BTA stat test detected 90% and 89% of primary, and 74% and 66% of recurrent tumors. Furthermore, all patients with carcimona in situ, high grade tumors, muscle invasive cancers and tumors larger than 2cm were diagnosed with the BTA stat Test. However, conditions like benign prostatic hyperplasia, kidney stones, or urinary tract infections may produce positive BTA stat Test results.

The BTA stat test is a simple non-invasive assay intended to be used only under the guidance of a doctor and only by patients who have a history of bladder cancer. The BTA stat test can easily be performed by the patient, in the doctors office, or by a laboratory. Simple sample collection allows for improved patient comfort and compliance. The doctor will use the information from this test along with information from a cystoscopy examination to make a decision about the patient’s medical care.

Bladder cancer is the fourth most common cancer among men and the eighth most common among women which requires regular testing for recurrence and lifelong management. Approximately 75 to 85% of these patients present with transitional cell carcinoma (TCC) confined to the superficial mucosa of the bladder. This newly granted marketing clearance offers physicians and patients more opportunities to use the BTA stat test to detect recurrent disease. This is especially important considering the risk of recurrence for TCC patients is 75%. Increased detection rates may result in fewer cancers missed and improved outcomes.

 

* B.D.S., Inc. (formerly Bard Diagnostic Sciences, Inc.) is a subsidiary of Polymedco, Inc.

BTA stat and BTA TRAK are registered trademarks of Polymedco, Inc.

 

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