Yourgene Health plc

The COVID-19 pandemic is an ongoing global pandemic. COVID-19 (also known as coronavirus) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Coronaviruses are enveloped RNA viruses.They are named as such because of the spike proteins that protrude from their surface. SARS-CoV-2 is one of a total of 7 coronaviruses that commonly infect humans, and is one of the 5 beta coronaviruses.

It became apparent that more accurate testing was required to correctly identify those infected with COVID-19. Yourgene Health has developed a highly accurate* Clarigene ® SARS-CoV-2 test. This is currently available for research purposes only. A CE-IVD kit is also available now .

Key Features:
Fast turnaround time after RNA extraction.
High accuracy with 100% specificity*
Human RNase P control designed as a true RNA control to ensure low false-negative results
Assay uses an N-gene target that is SARS-CoV-2 specific, so there is no cross-reactivity with other coronaviruses
Kit includes master mix, ROX, primers and probes
Compatible with RNA extracted from nasopharyngeal swabs
Assay can be easily adapted to an automated workflow
RUO kit contains reagents for 96 samples
Compatible with qPCR instruments such as Roche LightCycler, ABI 7500 and Quantstudio

JUST LAUNCHED!!!
Introducing IONA ® Nx NiPt Workflow (IONA ® nx), Yourgen of the new , innovative NiPt Workflow, running on the Illumina Nextseq 550 Dx - platform.



Why is IONA ® Nx different from many other NIPT solutions on the market?:

Flexible & fast: automated (2 days) and manual (3 days) workflows available
Scalable: low to high volume runs (16 to 48 samples per run)
Cost-effective: lower capital requirements and higher sequencing efficiency
Innovative: fetal fraction enrichment step with Yourgene QS250 instrument that increases fetal fraction by x2
Quality: CE-IVD
High performance: >99.99% accurate

Flexible yet controlled; bioinformatics software platform for medical purposes, enabling application diversity


Yourgene Flex ™ Analysis Software is designed to build on the excellent bioinformatics technology and expertise of IONA ® Software .Yourgene Flex ™is a modular next-generation sequencing (NGS) analysis framework that leverages world-class bioinformatics pipelines to provide high-quality, robust, yet flexible NGS analysis solutions.Enabling Yourgene to support our in vitro diagnostics (IVD) product development partnerships and research collaborations with key industry players . Yourgene Flex ™ analysis software is also provided internally to support our own internal
Support product development pipeline across the reproductive health and oncology portfolio.

Yourgen Flex ™ Analysis Software
key features

The Flex ™ framework includes key software components that read, filter, analyze, and rigorously review complex sequencing data to produce a customized clinical test report that is clear and easy for a clinician to interpret
No in-house bioinformatics expertise is required to analyze sequencing data
A unique, reconfigurable, NGS IVD medical analysis software framework
All code developed within a fully validated, risk-managed process
The modular approach allows for the reuse of validated core modules and the development of fully custom routines if required
The modular design of Yourgene Flex ™ will allow customers to run multiple different tests on a single platform in the future
All elements of the software are developed according to the internationally recognized ISO/IEC 62304 standard to ensure the highest quality medical software that will also support all future IVD regulatory submissions
To learn more about Yourgene Flex ™ and how it can be used to support your NGS assay development, please email partners@yourgene-health.com