Gnomegen is focused on developing clinical ready reagents, consumables and instruments including those related to digital PCR and next generation sequencing.The company is developing products for detection of viral infection and liquid biopsy detection tools for cancer. Gnomegen is developing real-time digital PCR assays for cancer companion diagnostics and its digital PCR instrument with the aim of achieving early detection of relapse and progression of cancer.
Gnomegen received an emergency use authorization from the FDA for its COVID-19 RT-Digital PCR Detection kit in April, 2020 and for its COVID-19-RT-qPCR Detection Kit in May, 2020. The company’s COVID-19-RT-qPCR Detection Kit detects the SARS-CoV-2 N gene in nasopharyngeal and oropharyngeal swab specimens. The kit uses Qiagen’s QIAmp DSP Viral RNA Mini Kit for RNA purification and concentration of samples and the PCR reaction runs on Thermo Fisher Scientific’s Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with SDS 1.4 software. Israel-based company, Todos Medical, acquired the exclusive distribution rights for Gnomegen’s digital PCR and qPCR SARS-CoV-2 tests in North America, Europe, Southeast Asia and Latin America.