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 specimen matrices from each study participant: finger stick capillary whole blood, venous whole blood, serum and plasma. Based upon the results of the studies and other related information provided to the FDA, the PMA supplement was approved to expand the indications-of-use section to include the pediatric sub-population, 13 to 17 years of age.
Of the more than 1 million adults and adolescents estimated to be living with HIV infection in the United States, approximately 21 percent are unaware of their infection. Lowering the testing age from 18 years of age to 13 is consistent with the latest U.S. Centers for Disease Control (CDC) recommendations that routine screening for HIV be performed on all patients 13 to 64 years of age. From a public health perspective, the shift in the CDC recommendations from risk-based to routine “opt-out” testing is anticipated to lower the rate of new HIV infections.
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