By using US/South Korea/China-patented DNA microarray technology, GoodGene has developed a DNA microarray, GG Human Papilloma Virus DNA chip, which can detect clinically important human papillomaviruses in entirety, used and validated in many countries, and which has been one of the first HPV DNA chips ever developed around the world. (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.
The DNA chips can analyze the more than 40 types of HPV found in the cervical, diagnose complex infection by at least one type of HPV, and have excellent diagnostic sensitivity and specificity on HPV genetic type up to 100% and reproducibility. Also, the DAN 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 the use of this DNA chip, we are searching for laboratories to collaborate for the widespread use of microarray technology for HPV genotyping.
Publications:
- Zhou H, Schwartz MR, Coffey D, Smith D, Mody DR, Ge Y. Should LSIL-H be a distinct cytology category?: A study on the frequency and distribution of 40 human papillomavirus genotypes in 808 women. Cancer Cytopathol. 2012 Dec 25;120(6):373-9. doi: 10.1002/cncy.21210. Epub 2012 May 30. PMID: 22648956.
- Kim KH, Yoon MS, Na YJ, Park CS, Oh MR, Moon WC. Development and evaluation of a highly sensitive human papillomavirus genotyping DNA chip. Gynecol Oncol. 2006 Jan;100(1):38-43. doi: 10.1016/j.ygyno.2005.08.024. Epub 2005 Oct 10. PMID: 16216319.
- Quiroga-Garza G, Zhou H, Mody DR, Schwartz MR, Ge Y. Unexpected high prevalence of HPV 90 infection in an underserved population: is it really a low-risk genotype? Arch Pathol Lab Med. 2013 Nov;137(11):1569-73. doi: 10.5858/arpa.2012-0640-OA. Epub 2013 Feb 20. PMID: 23425019.
- No JH, Sung MW, Hah JH, Choi SH, Lee MC, Kim HS, Song YS. Prevalence and prognostic value of human papillomavirus genotypes in tonsillar squamous cell carcinoma: a Korean multicenter study. Cancer. 2015 Feb 15;121(4):535-44. doi: 10.1002/cncr.29086. Epub 2014 Oct 3. PMID: 25283642.
- B Lee, HY Cho, KJ Jeon, K Kim, JR Lee, JJ Moon, Detection of high‐risk human papillomavirus using menstrual blood in women with high‐grade squamous intraepithelial lesions or high‐risk human papillomavirus infections: A pilot study. Journal of Obstetrics and Gynaecology Research, 2016 42 (3), 319-324
- Lee SM, Park JS, Norwitz ER, Koo JN, Oh IH, Park JW, Kim SM, Kim YH, Park CW, Song YS. Risk of vertical transmission of human papillomavirus throughout pregnancy: a prospective study. PLoS One. 2013 Jun 13;8(6):e66368. doi: 10.1371/journal.pone.0066368. PMID: 23785495; PMCID: PMC3681772.
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