, a maker of medical testing equipment, saw its shares climb 14% to $6.60 after receiving regulatory approval to market its OraQuick HIV test, a blood test that produces results within 20 minutes.
The Food and Drug Administration based its approval on clinical data submitted by OraSure indicating that the test met sensitivity and specificity requirements in the studies performed with finger-stick whole blood specimens. Sensitivity measures accuracy for detecting positive specimens, while specificity is a measure of the accuracy for identifying negative specimens.
Back in June, Bethlehem, Pa.,-based OraSure granted
the co-exclusive rights to distribute OraQuick in the United States. With this FDA approval, OraQuick will be available for sale to the nearly 40,000 qualified locations in the U.S., where an estimated 17 million HIV tests are conducted each year.
Shipments from OraSure to Abbott are expected to begin in the next 30 to 60 days.