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Bion Diagnostic Sciences' BTA stat

This article was originally published in The Gray Sheet

Executive Summary

Firm's rapid test for detection of bladder cancer receives "waived" categorization status under the Clinical Laboratory Improvement Amendments from the Centers for Disease Control and Prevention. The tumor marker assay was cleared by FDA for prescription home use in December ('The Gray Sheet" Jan. 4, p. 14). The test's new categorization permits physicians to use the test in offices and laboratories with CLIA-waived certificates during the patient's office visit, providing immediate clinical information on patients being monitored for recurrent bladder cancer
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