Gnomegen LLC
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COVID-19 RT-Digital PCR Detection Kit

About Us

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Our Vision

To help cancer patients live longer and better with innovative liquid biopsy tools for early detection of relapse and progression of cancer


Our Mission

To develop low cost clinically ready tools that meet unmet needs in liquid biopsy with higher sensitivity and more accurate quantification


Our Technology 

Patent pending technologies for Digital Real Time PCR (Drt PCR) to achieve higher sensitivity, better quantification and multiplexed mutation detection in a single assay

Our Products

Real Time Digital PCR Instrument - Combine Digital PCR & Real Time Monitoring


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 


Real Time Digital PCR Assays for Cancer Companion Diagnostics and Monitoring


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 

News Release

Gnomegen COVID-19 RT-Digital PCR Assay Kit: A Novel Solution for the Detection of SARS-CoV-2 Virus

  

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 RT-Digital-PCR 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-Digital-PCR 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 digital PCR 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-Digital-PCR 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 (dPCR) 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. 

On a global scale, we look to partner with distributors for our current pipeline of products. For more information visit www.gnomegendx.com or email sales@gnomegendx.com


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. 


Contact Information
sales@gnomegendx.com
Phone: 858-375-7581

6440 Lusk Blvd Suite D207 

San Diego CA 92121

Contact Us

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Gnomegen LLC

6440 Lusk Boulevard, Suite 207, San Diego, CA 92121

Tel: (858)375-7581 Email: info@gnomegendx.com

Hours

Monday - Friday: 8:00am - 5:00pm

Saturday - Sunday: Closed