By using US/South Korea/China-patented DNA microarray technology, GoodGene has developed a DNA microarray, GG STD DNA chip, which can detect clinically important STD pathogens in entirety, which has been one of the first STD DNA chips ever developed around the world and the first to our knowledge of STD multiplex microarrays including more than 4 pathogens. (Approved for use in Europe/Asia per CE/ISO and NOT AUTHORIZED OR CLEARED FOR USE IN THE USA)
Although commonly used, PCR/Sequencing is labor-intensive and impractical for high throughput screening of respiratory diseases required in clinical laboratories. The FDA-approved real-time PCR tests are effective for qualitative detection, but notable for two major limitations 1) constrained spectrum of bacterias/viruses detected, and 2) non-specific dichotomous results. These limitations, therefore, urge the development of a comprehensive, sensitive, specific, automated test that has broad clinical applications from epidemiological surveillance to vaccine development.
GG STD genotyping DNA microarray (Goodgene, Korea) is a Korean FDA-approved molecular test tool which can simultaneously detect 9 pathogens of STDs, including N. gonorrhea, C. trachomatis, M. genitalium, M. hominis, U. urealyticum, T. vaginalis, T. pallidum, herpes simplex virus type 1 and type 2. They have excellent diagnostic sensitivity and specificity on STD typing up to 100% and reproducibility. Also, the DNA chips are superior to the conventional analytic methods, and very economical, since they can analyze numerous specimens in shortest time. Accordingly, DNA chips are useful for predicting cervical cancer and precancerous lesions.
It is a semi-automated essay and takes around 4 hours for two or three laboratory scientists to test hundreds of samples. The novel array in comparison to direct DNA sequencing offers the greatest specificity and breadth of detection for known single and mixed infections. To extend and translate this work into the clinical realm, we are searching for laboratories to collaborate for the commercialization and widespread use of microarray technology for STD typing.