Yesterday morning, Ireland-based Trinity Biotech (NASDAQ:TRIB) said it received FDA approval to market its Uni-Gold Recombigen HIV test in the U.S. Since the announcement, its shares have been on a tear, climbing 57% to $5.14 yesterday, and another 22% to $6.30 by early this afternoon.

The 10-minute, one-step test is for the detection of HIV antibodies in human serum, plasma, or whole blood, and is the only test approved for use in all three sample types. Trinity's test is also approved for use in the World Health Organization's HIV testing program in Africa, where the company sells four million tests per year.

In the U.S., the company expects to sell 400,000 to 500,000 of the $10 tests in 2004.

According to Trinity, more than 800,000 needle stick injuries occur every year in the U.S., which require an immediate HIV test. In addition, approximately 200,000 "at risk" pregnant women each year require a rapid HIV test to help prevent potentially passing the disease to their children. The company sees this application as a $10 million market.

Trinity also sees a $30 million market opportunity from the conversion of traditional lab-based testing. With 40,000 new HIV infections every year, Trinity cited Center for Disease Control (CDC) experience in saying that up to 40% of those tested for HIV using conventional lab-based tests don't return for the results. But with a 10-minute test, Trinity's product translates as a substitution for conventional lab tests nicely. In clinical trials with over 9,000 patients, Trinity's test detected positive cases with 100% accuracy.

Shares of rival OraSure Technologies (NASDAQ:OSUR) have slipped on the news. OraSure's 20-minute OraQuick Rapid HIV-1 test was approved in November 2002 and has already seen significant orders from the CDC.

Put in your two cents on the OraSure Technologies discussion board.

Jeff Hwang can be reached at