- ALL of Cellgenemedix’s COVID-19 products have been validated in multiple variants with clinical samples and commercial and verified commercial control materials.
- GG COVID-19 variant PCR test and GG Good Agworks well on Omicron and Delta variant specimens (>100-500 specimens verified), as well as multiple other verified control materials.
- Approved for use in Europe/Asia per CE/ISO and NOT AUTHORIZED OR CLEARED FOR USE IN THE USA
- A real-time RT-PCR test intended for the qualitative detection of nucleic acid from COVID-19 (Brochure) approved by the Korean Export, USPTO, and European CE mark
- Respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider or self collected nasal swabs (Good Ag Home COVID-19 Antigen Test)
- Rapid and accurate identification of severe acute respiratory syndrome coronavirus 2 (COVID-19, COVID-19; SARS-CoV-2) with excellent adaptability to multiple clinical specimens and Real-Time PCR machines
- GG COVID-19 I-plex Real-Time PCR: diagnosis of influenza virus-A(H1N1/H3N2)/B as well as COVID-19 (N).
- GG SARS-CoV-2 Omicron & Delta RT-PCR test: screening and diagnostic test for SARS-CoV-2 and screening for Omicron/Omicron stealth and Delta at the same time in 1 tube
- GG Pan-Res Virus DNA chip : detect and genotype respiratory viruses including different types of influenza viruses, respiratory syncytial viruses, adenoviruses, rhinoviruses, coronaviruses, and COVID-19.
Sample Quality
Variety of respiratory specimens such as nasopharyngeal, oropharyngeal, nasal swabs, bronchoalveolar lavage, tracheal aspirate, or sputum. Because the performance of this kit was proven on sputum specimnes, this kit can be applied in many clinical situations. Testing is limited to laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests. Refer to https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html for guidelines on specimen collection.
Manufacturing Capacities
The current manufacturing capabilities at GoodGene, InC include the ability to manufacture approximately 100,000 test products per week, however in the event of a surge in demand this could be increased to 200,000 test product per week within a 1 week time frame. All products can be delivered internationally within 3 to 10 business days depending on customs.
Individual info and quote
| Name | Goal | Method | Specifications | Certification |
| GG Covid-19 Good Ag Rapid test | Screen at home and in clinic for Coronavirus Disease-19 (COVID-19) | lateral flow assay with US-patented latex particles; rapid antigen test | Visual inspection | CE mark achieved ISO 13485 acquired USPTO patent |
| GG Covid-19 Quadplex Real-Time PCR | Detect COVID-19 with excellent accuaracy and specificity (~100%) | Quadplex real time PCR assay, 1 tube | Reprodudibility proven and Compatible with; Rotorgene-Q (Qiagen, Hilden, Germany), ABI 7500 (Applied Biosystems Inc., Foster City, CA) and CFX96 (Bio-Rad, Hercules, CA) | CE mark achieved ISO 13485 acquired Korean Export permission acquired by Korean Ministry of Food and Drug Safety USPTO patent |
| GG Covid-19 Omicron & Delta Real-Time PCR | Detect presence of COVID-19 in addition to screening for Delta/Omicron | Quadplex real time RT-PCR assay, 1 tube | ||
| GG COVID-19 VOC Real-Time PCR | diagnosis of COVID-19 (N) and its 8 variants. | Quadplex real time RT-PCR assay, 2 tube | ||
| Pan-Res Virus DNA chip | Pan-respiratory Virus Detection DNA Microarray | Detect entire virus which infect human respiratory tract | Chip scanner (rental possible in South Korea) | Clinical investigation status USPTO patent |
*For Investigational Use Only in the USA but available and approved for sale in Europe and Asia.
*The performance characteristics of this product have not been established in the USA.
*NOT AUTHORIZED OR CLEARED FOR USE IN THE USA