History

2008 ~ 2021

2021

  • 04 Developed an mRNA assay kit for early diagnosis and post-treatment monitoring of breast cancer with Exogene Pte.Ltd in Singapore
  • 06 Launched HealthyGuardTM DTC genetic test product (on sale in 8 online channels)

2020

  • 06 DLP™Q COVID19 Real Detection Kit FDA Registration Certificate
  • 07 DLP™Q COVID-19 RT-LAMP Kit CE-IVD certified
  • 09 DLP™Q COVID-19 RT-LAMP Kit Obtained medical device manufacturing license from the Food and Drug Administration
  • 12 “Multiple microRNAs as biomarkers for early breast cancer diagnosis” treatise submission

2019

  • 01 Japanese Patent Application for Method of Detection of Target Nucleic Acid Sequence by Multiple Amplification Double Signal Amplification
  • 04 Certified export business for DLP™C TumorClean Kit

2018

  • 02Selected as influential CEO in Korea
  • 02DLP™C STI26 Detection Kit Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 03Best "Class A" for 4 consecutive years of genetic testing accuracy assessment
  • 02DLP™C Cancer Detection Kit(Jak2,ERBB2,DPC4,BCR-ABL,PRSS1) Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 01DLP™Q STI 12 Real Detection Kit Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 06DLP™Q M.TB/N™ Real Detection Kit Obtained a Medical Device Manufacturing License from the Food and Drug Administration

2017

  • 05DLP™C malaria Detection Kit Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 06Selected as a family company by the Small and Medium Business Corporation
  • 07DLP™C Dengue 4 Detection Kit Obtained Medical Device Manufacturing Item Permission from Ministry of Food and Drug Safety
  • 08Korea Economic Leader Award
  • 09Patent registration of target nucleic acid sequence detection method by multi-amplification double signal amplification
  • 10Human papillomavirus genotyping ISD™HPV35 AES Genotyping Kit listed as medical care benefit
  • 12Technology evaluation excellent company certification

2016

  • 08DLP™C BRCA Mutation Detection Kit Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 07Nucleic acid amplification method patent application by multi-amplification double real-time linear amplification
  • 07Lower urinary tract genital infection test ISD™ STD12 AES Detection Kit listed as medical care benefit
  • 02Signed a research agreement with Gachon University Gil Hospital affiliated BRC Research Center

2015

  • 01Registered a patent for a method for detecting bacteria that causes sexually transmitted diseases using a liquid bead array and a multi-polymerase chain reaction method
  • 01ISD™C Multiplex Detection Kit(HBV) Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 01DLP™Q MAMA Mutation Detection Kit(APC,CDH1,MLH1) Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 02GenSol ™Clinic Genomic DNA Extraction Kit Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 02Divial™ Liquid Transport Medium Kit Obtained a Medical Device Manufacturing License from the Food and Drug Administration

2014

  • 03DLP™C HLA-B27 ABS Detection Kit Obtained medical device manufacturing item license from Ministry of Food and Drug Safety
  • 03Joint research agreement with Naeun Hospital, Luga Medical Foundation04 Registered patent for oncogenic HPV detection method using liquid bead array and multi-polymerase chain reaction
  • 04Registered a patent for oncogenic HPV detection method using liquid bead array and multi-polymerase chain reaction
  • 05Patent registration for oncogenic HPV type identification method by double multiple reverse transcription polymerase chain reaction
  • 11Patent registration of DNA chip for human papillomavirus genotyping, kit including the same, and human papillomavirus genotyping method using the same
  • 11ISD™C Multiplex Detection Kit(Meningitis,Pneumobacter) Obtained a Medical Device Manufacturing License from the Food and Drug Administration
  • 11Recognition of new medical technology for lower urinary tract genital tract and sexually transmitted infection causative agent multipolymerase chain reaction method (ISD™ STD12 AES Detection Kit) DLP™Q MAMA Mutation Detection Kit (BRAF, EGFR, MTHFR, pRB) acquired medical device manufacturing item license from Ministry of Food and Drug Safety
  • 12DLP™Q MAMA Mutation Detection Kit(BRAF,EGFR,MTHFR,pRB)Obtained a Medical Device Manufacturing License from the Food and Drug Administration

2013

  • 12Medical device manufacturing GMP certification
  • 05Certified for manufacturing and sales of reagents for ISO 13485 gene amplification devices
  • 03HPV35, STD12 manufacturing item approval
  • 01Permission to manufacture reagents for gene amplification devices

2012

  • 11Patent application for HPV type detection method by liquid bead array and multi-polymerase chain reaction
  • 09Started tuberculosis and HLA-B27 testing service
  • 06Molecular diagnosis source technology development

2011

  • 12ISO9001:2008 quality management system certification
  • 10Participated in quality control of genetic testing and evaluation institut
  • 06Yeouido Central Screening Center and National Fitness Center cancer gene service launched

2010

  • 07Launched new cancer gene methyl DNA blood test service

2009

  • 12Initiation of infectious disease testing service in 5 major consignment institutions
  • 07Established Diogene Co., Ltd.
  • 05Certification of R&D department
  • 04Venture business certification