To help cancer patients live longer and better with innovative liquid biopsy tools for early detection of relapse and progression of cancer
To develop low cost clinically ready tools that meet unmet needs in liquid biopsy with higher sensitivity and more accurate quantification
Patent pending technologies for Real-Time Digital PCR (RT dPCR) to achieve higher sensitivity, better quantification and multiplexed mutation detection in a single assay
Real-time dPCR instrument allowing for higher sensitivity and better quantification than end point dPCR
6 fluorescent channels with 7 dyes enabling multiplex detection of up to 5 different mutations per reaction
8 independently controlled heating stations for flexibility in temperature settings and target dye selection
HER2 Amplification Detection Kit for Breast Cancer, Gastric Cancer and Non-small Cell Lung Cancer – available now
EGFR Mutation Detections Kit for Non-small Cell Lung Cancer – available now
PIK3CA Mutation Detection Kit for Hormone Receptor Positive Breast Cancer – available Q3, 2020
SAN DIEGO, CA – April 6, 2020 – Today, Gnomegen announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for the Gnomegen COVID-19 Real-Time Digital PCR (RT dPCR) Detection Kit, which provides a more sensitive and accurate detection of the SARS-CoV-2 virus. Compared to current qPCR methods, the Gnomegen COVID-19 RT dPCR Detection Kit is 4X more sensitive with a limit of detection of 2.5 copies per reaction in comparison to qPCR platforms at 10 copies per reaction using the same kit. At this limit of detection, qPCR identifies 62.5% positive while dPCR identifies 95% of positive sample replicates. This improvement in the limit of detection would better protect the population from potential false negative results.
The Gnomegen COVID-19 RT dPCR Detection Kit for use on the high throughput QuantStudio 3D Digital PCR System is capable of running up to 24 samples per run allowing up to 48 samples to be tested per day on a single device further increasing the speed of COVID-19 diagnosis.
The Gnomegen COVID-19 Test is a qualitative test using digital polymerase chain reaction technology to detect SARS-CoV-2 (the virus responsible for COVID-19) via oropharyngeal and nasopharyngeal samples. Gnomegen’s coronavirus test yields laboratory-quality results in approximately 3 hours.
About Gnomegen LLC
Gnomegen is located in sunny San Diego, CA with a focus on clinical ready reagent, consumable and instrument development. Gnomegen’s current pipeline of products are based on digital PCR and next generation sequencing. Alongside COVID-19 EUA kit, Gnomegen will continue develop and register additional FDA products on viral and liquid biopsy detection.
6440 Lusk Blvd Suite D207
San Diego CA 92121
Gnomegen COVID-19 RT dPCR Detection Kit