Orasure Rising on HIV Test Approvable Letter - TheStreet


(OSUR) - Get Report

was rising in the Instinet premarket session after receiving an FDA approvable letter for a test that looks for HIV in blood taken from a finger.

The OraQuick test is intended to detect HIV-1 antibodies in finger stick whole blood within 20 minutes.

Final approval is subject to the company submitting product labeling and resolving specific validation and design control issues identified during the FDA's recent preapproval inspection of the company's manufacturing facilities. Orasure said it intends to resolve all issues identified by the FDA "as soon as possible."

The company's shares were recently up 16% at $8.50 on Instinet.