The BTA statģ TEST GRANTED WAIVED TEST CATEGORIZATION
The BTA stat test becomes the first tumor marker test to be placed in the CLIA waived category by the CDC. The test detects bladder tumor associated antigen in the urine of persons undergoing monitoring for recurrent bladder cancer.
Cortlandt Manor, NY - February 3, 1999The BTA stat test, manufactured by BDS, Inc., Redmond, WA, was granted waived status under the Clinical Laboratory Improvements Act (CLIA) by the CDC today. Physicians can now use the test in offices and laboratories with CLIA waiver certificates to detect recurrent bladder cancer as an aid in the management of bladder cancer patients in conjunction with cystoscopy. This historic categorization for a tumor marker assay makes it possible for most physicians to perform the test during the patientís office visit, therefore providing an immediate clinical assessment to guide the patientís management plan.
"The BTA stat is more sensitive, less expensive, and faster than urine cytology. This categorization gives physicians the ability to perform this test at the time of a visit, thus adding valuable immediate information," commented Dr. Michael Sarosdy of San Antonio, the lead investigator of the BTA stat test and a leading bladder cancer expert.
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).
Previously, this simple test was categorized by the CDC as moderately complex, requiring physicians wishing to perform the test in their offices to maintain a moderately complex or highly complex lab certificate. Waived tests are exempt from the CLIA health and safety standards, but should be performed in accordance with "Good Laboratory Practice" standards. The FDAís recent clearance of the BTA stat test for prescription home use allowed the test to be automatically waived by the CDC.
The BTA stat test uses monoclonal antibodies to detect bladder tumor associated antigen, identified as human complement factor H related protein (hCFHrp). In cell culture, hCFHrp was shown to be produced by several human bladder cancer cell lines, but not by normal epithelial cell lines.
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 doctor's 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 visual bladder examination to make a decision about the patientís medical care.
The BTA stat test compliments the BTA TRAK quantitative assay which received FDA clearance on April 15, 1998. Together the BTA tests provide the only true system approach for bladder cancer patient management.
In a multicenter study, the BTA stat test was found to have a sensitivity of up to 90% for T1 stage tumors. In the same study, the test had a specificity of 93% in patients with non-genitourinary diseases and cancers, and 95% in healthy subjects.
There will be an estimated 60,000 new cases of bladder cancer diagnosed in 1999. This patient subpopulation will be added to the approximately 500,000 bladder cancer patients currently requiring lifelong management. Approximately 75% of bladder cancers recur. Increased detection rates may result in fewer cancers missed and improved outcomes.
* Bion Diagnostic Sciences, Inc. (formerly Bard Diagnostic Sciences, Inc.) is a subsidiary of Polymedco