Chembio Diagnostics, Inc. (CEMI.OB) Announces FDA Approval for Extended Age Range for Routine HIV Testing
Chembio Diagnostics, Inc. (CEMI.OB), a developer, manufacturer and marketer of proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market, recently announced that the company has received approval from the United States Food and Drug Administration to extend the testing age range for its HIV rapid point-of-care tests to individuals 13 years of age and older. A recent clinical study was designed to evaluate the performance of the company's FDA-approved rapid tests, Clearview® COMPLETE HIV 1/ 2 and Clearview® HIV 1/ 2 STAT-PAK®. The University of Maryland School of Medicine performed the study for Chembio on four separate…