In 1988, Gen-Probe marketed the PACE® System, which used non-amplified probes to detect Chlamydia trachomatis and Neisseria gonorrhoeae. The PACE® 2 product line later followed this product.
In subsequent years, several manufacturers offered amplified assays for both Chlamydia and Neisseria. Automating 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. Around the same time, the Abbott LCx semi-automated platform, based on ligase chain reaction, was also introduced.
Shortly after, Gen-Probe offered its APTIMA Combo 2® Assay, an amplification assay that utilized target capture. Later, 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.
