When the main reason a product becomes successful starts threatening its continued success, something has to change.  For Gen-Probe Incorporated, a fast-growing San Diego pioneer in genetic diagnostics for disease testing, that happened when its newest test for sexually transmitted diseases proved so sensitive that it can respond to specimens opened for similar test processing elsewhere in the lab.

  Solving that problem by inventing a new type of penetrable sealed cap for specimen tubes led to another problem; the cap worked so well that rising customer demand for its use in other Gen-Probe assay kits promised to exceed the company’s ability to produce and test them.  An advanced system integrating automated assembly and testing became an urgent priority, not only for increasing volume but also for cutting costs.

  Gen-Probe’s APTIMA Combo2 Assay, FDA-cleared for marketing in 2001, is one of the newest among more than 50 test systems developed by the company since 1985 for diagnosing such diseases as Legionnaires’ Disease, Myobacterium Tuberculosis or Group A Streptococcus, and screening donated blood for human immunodeficiency virus type 1 (HIV-1) or hepatitis C virus (HCV).  As a second-generation improvement, APTIMA was the first assay to provide simultaneous detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoea (GC) infections, yet be able to use urine or ocular fluid samples with equivalent performance to first-generation tests that required intrusive and sometimes painful swab samples.

  These patient-friendlier sampling alternatives encourage broader testing among high-risk populations, while simultaneous detection of both diseases is important because they appear...

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