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Chlamydia trachomatis and Neisseria gonorrhoeae

In 1988, Gen-Probe marketed the PACE® System, using non-amplified probes for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. This product was later followed by the PACE® 2 product line.

Amplified assays for both Chlamydia and Neisseria followed in subsequent years, offered by several manufacturers. Automation of at least some parts of the process made it more feasible for clinical laboratories to incorporate molecular methods into their test menus.

Roche developed a polymerase chain reaction (PCR) methodology focusing on specific nucleic acid sequences for both organisms. The Roche COBAS® AMPLICOR assay, on a semi-automated platform, obtained Food and Drug Administration (FDA) clearance in 1999. The Abbott LCx® semi-automated platform, based on ligase chain reaction, was also introduced around the same time.

Shortly thereafter, Gen-Probe offered their APTIMA Combo 2® Assay, an amplification assay that utilized target capture. Later on, the TIGRIS® automated system by PROCLEIX® was added to provide automated specimen processing, enhancing the efficiency of the product line.

Becton Dickenson then entered the arena, with the ProbeTec, another semi-automated system based on strand displacement amplification.

Digene also marketed its hybrid capture assay for Chlamydia and Neisseria. Unlike the other commercial assays, this method did not amplify the target DNA sequence, but instead employed a chemiluminescent methodology to amplify the signal of RNA:DNA hybrids.