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Press Release

The BTA TRAK® Assay monitors bladder cancer patients over a lifetime.

Cortlandt Manor, NY - December 14, 1998 The BTA TRAK® assay is an enzyme immunoassay (EIA-Elisa) intended for the quantitative measurement of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer. It allows for monitoring of disease progression as an accurate non-invasive adjunct to cystoscopy. Serial measurements may aid in detecting persistent disease following surgical or medical treatment for bladder cancer. BTA TRAK® results may predict recurrence by detecting tumors not visualized by cystoscopy. It has superior sensitivity and specificity which is useful in monitoring patients for disease progression and recurrence.

The BTA TRAK® assay is a non-invasive test; simple voided urine allows for improved patient compliance, comfort and management. The antigen measured was identified as human Complement Factor H related protein (hCFHrp) which apparently plays a key inhibitory role in the control of the alternate complement pathway that functions to lyse cells recognized as foreign to the host. This assay is a true tumor marker as confirmed by cell culture.

The BTA TRAK product received FDA clearance on April 14, 1998. The BTA TRAK assay reduces costs by providing precise results, lower labor costs and lower billing cost compared to other standard procedures.

 

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