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IVD Technology Magazine | IVDT Article Index

Originally published January, 1997

Editor's Page

A graceful entrance

On a misty Southern California morning recently, I was called to attend a press conference cosponsored by American Red Cross Biomedical Services and the San Diego­based biotechnology firm, Gen-Probe, Inc. Freshly named to take over the helm of IVD Technology (more about that later), I was naturally eager to make a good impression. But as I entered the conference room, my rain-slick shoes encountered an equally slick patch of marble, and I found myself suddenly sprawled on the floor.

Recovering my footing and composure, I turned to the business of the press conference, which was to announce that the National Heart, Lung, and Blood Institute (NHLBI) had awarded Gen-Probe a three-year, $7.7-million contract to develop a rapid test for HIV and hepatitis C (HCV), to be used in screening the nation's blood supply. The company's winning proposal makes use of its patented transcription mediated amplification (TMA) technology, which was first approved for use in the United States in 1995 as part of the company's tuberculosis diagnostic.

The unique characteristic of TMA is that it amplifies ribosomal RNA instead of the DNA amplified in polymerase chain reaction. Gen-Probe officials expect that the new test will reduce the time required to detect HIV from 16 to 11 days. The fully automated test will be priced "somewhere between $6 and $10," adding slightly to the current cost of testing a unit of blood, but efficiencies will be gained by combining the tests for HIV and HCV. Company officials expect to obtain FDA approval for the test before the end of 1999.

There's no question about the importance of this award to Gen-Probe. According to Gen-Probe president and CEO Hank Nordhoff, the NHLBI contract will increase the company's annual R&D budget by about 14%. Equally striking, however, is the speed with which the federal government has moved to support development of a diagnostic based on the relatively new TMA technology. With that kind of support, Nordhoff likes the chances of TMA's success. "We think we have a very strong technology," he says. The company hopes that TMA will become the amplification method of choice for many applications.

No doubt, the competition among companies and technologies that characterizes the field of IVDs is also a marker of the industry's vitality. As the new editor of IVD Technology, I hope that I will be able to capture some of that liveliness and bring it to our pages.

As my debut, this issue of IVD Technology is certainly more graceful than my entry to the Gen-Probe press conference. It has benefited from the influence of my predecessor, Jenevieve Blair Polin, who ably guided the publication through its launch and first year as an independent journal, and will remain a contributor to the publication in her new role as editor at large. But the pratfalls--editorial and otherwise--are clearly my own.

Steven Halasey
steve.halasey@cancom.com


Copyright© 1997 IVD Technology