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Biosite Aiming For Stroke Diagnostic PMA Submission In 2003

This article was originally published in The Gray Sheet

Executive Summary

Biosite's stroke diagnostic markers are more than two times as sensitive as CT scans in detecting ischemic stroke, the firm maintains.

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Biosite Triage BNP Reduces Diagnosis Uncertainty To 11%, NEJM Study Finds

Biosite plans to file a 510(k) application in mid-2003 seeking a therapeutic monitoring indication for its Triage B-type natriuretic peptide (BNP) test to aid in diagnosis of congestive heart failure

Biosite Triage BNP Reduces Diagnosis Uncertainty To 11%, NEJM Study Finds

Biosite plans to file a 510(k) application in mid-2003 seeking a therapeutic monitoring indication for its Triage B-type natriuretic peptide (BNP) test to aid in diagnosis of congestive heart failure

Biosite’s Triage TOX

Drug screen to detect overdose levels of eight commonly abused drugs will complement firm's Triage drugs of abuse panel, Biosite says in a Jan. 17 announcement. The point-of-care assay is performed by placing a urine sample on a protein chip with microcapillary structures that direct the sample's flow through immobilized antibody zones. The protein chip is then inserted into Biosite's Triage MeterPlus to produce a result within 15 minutes. Firm is developing test for stroke to be used with the Triage MeterPlus (1"The Gray Sheet" Aug. 13, 2001, p. 12)...

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