Inside the RANGER Program
How QbD Group supports the development and IVDR certification of a respiratory pathogen panel
The RANGER program (RApid Next Generation Sequencing for Effective Medical Response) is an EU-funded consortium led by Ginkgo Bioworks, supported through the EU4Health program up to €24 million, and connected to the priorities of the Health Emergency Preparedness and Response Authority (HERA) of the European Commission.
QbD Group joined the RANGER consortium in February 2025 and has been contributing across multiple disciplines since.
€24M
EU4Health funding
6 partners
Across technology, genomics and diagnostics
4 EU hospitals
Clinical performance study sites
Since Feb 2025
QbD Group active in consortium
Background
About the RANGER program
RANGER pursues two complementary objectives.
The first is the development of an in vitro diagnostic (IVD) medical device capable of detecting a defined panel of respiratory pathogens in nasopharyngeal swab samples, including SARS-CoV-2, seasonal human coronaviruses, Influenza A and B, Human Rhinovirus / Enterovirus, Human Bocavirus, Human Respiratory Syncytial Virus, Adenovirus, and Human Metapneumovirus. The device is built on metagenomic next-generation sequencing (mNGS), designed for use in a laboratory setting, and delivers results within approximately 13 hours.
The second is the development of an "agnostic" research-use-only (RUO) tool designed to detect any pathogen across various sample types. While not intended for clinical diagnostic use, it may provide value in pathogen surveillance, epidemiological investigations, and broader research settings.
The consortium
Partners & clinical sites
The consortium brings together technology, genomics, diagnostics and clinical partners: Ginkgo Bioworks (consortium lead), Jumpcode Genomics, TGen (part of City of Hope), BugSeq, Planet Innovation, and QbD Group.
Clinical performance studies will be run at four leading EU hospitals: KU Leuven (Belgium), Karolinska University Hospital (Sweden), Leiden University Medical Center (Netherlands), and Tartu University Hospital (Estonia).
Our role
QbD Group's contribution
QbD supports the IVDR certification track of the program across four divisions, combining technical execution with deep regulatory and clinical expertise.
Software
Supporting BugSeq with software design and development.
Quality Assurance
Supporting BugSeq with the setup of its Quality Management System.
Regulatory Affairs
Providing consulting on the regulatory pathway towards IVDR certification.
Clinical
Acting as Clinical Research Organization (CRO) for the clinical performance studies at the four hospital sites.
Let's work together
Interested in partnering with QbD Group?
Whether you're exploring EU-funded consortium partnerships or looking for regulatory, clinical and quality support across your program, our team is ready to help.