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test is the APTIMA Combo 2
assay, which simultaneously detects chlamydia and gonorrhea,
the two most common bacterial STDs. Based in
part on the assay’s excellent performance in peerreviewed
studies, the APTIMA Combo 2 test is recognized
by many customers as a ”gold standard“ STD
product. In addition, the assay can be run on Gen-
Probe’s TIGRIS instrument, the only fully automated,
high-throughput system for molecular diagnostics. The
advantages of the TIGRIS instrument helped sales of
APTIMA products increase by more than 40% in 2006, to
over $100 million. This growth more than outweighed
the expected decline in sales of PACE® products, Gen-
Probe’s older family of STD tests. As a result, Gen-
Probe’s share of the $240 million US STD market
increased to an estimated 57% by the end of 2006, compared
to about 50% a year ago.
The APTIMA product line gained market share in 2006
based in part on several US regulatory approvals. For
example, the US Food and Drug Administration (FDA)
cleared the APTIMA Combo 2 assay to test new kinds of patient samples
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Linda Harshman (left), a Gen-Probe technical sales representative,
calls regularly on TIGRIS customer Susan Novak-Weekley,
PhD, director of microbiology at Kaiser Southern California
regional reference laboratory.
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