Epitope Inc. reported a third-quarter profit of $3.5 million, a dramatic turnaround from a $4.1 million loss a year earlier, in the wake of federal approval of its breakthrough HIV confirmatory test.
Earnings per share were 25 cents, compared with a loss of 34 cents per share a year ago.
Federal Drug Administration approval in June of Epitope’s OraSure HIV confirmatory test was key to the company’s turnaround, Adolph J. Ferro, president and chief executive officer, said Thursday.
“The FDA actions this quarter mean that our oral specimen collection product line is stronger than ever,” Ferro said.
The OraSure test relies on oral specimens, rather than blood samples, to confirm the presence of HIV, the virus that causes AIDS.
By eliminating the need for blood samples, the test also eliminates the risk of needle-stick injury to health care workers.
So far, sales of the test have been primarily for insurance risk assessment testing. But next week, SmithKline Beecham will launch the product in health care professional markets.