21st February, 2025
In collaboration with HaDEA and HERA, Ginkgo leads the RANGER project to create a point-of-care metagenomic sequencing device, aiming for 6-hour turnaround diagnostics to revolutionize pandemic preparedness and hospital triage across Europe.
Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced a collaboration with the European Health and Digital Executive Agency (HaDEA) as contracting authority under a joint tender of up to €24 million. The funding is made available through the EU4Health programme, linked to the key priorities of the Health Emergency Preparedness and Response Authority (HERA) of the European Commission.
The partnership, RApid Next Generation Sequencing for Effective Medical Response (RANGER), aims to develop a rapid, point-of-care metagenomic next-generation sequencing (mNGS) solution that enables hospitals and other healthcare facilities to achieve rapid turnaround diagnostics for respiratory viruses - capabilities that move us closer to a "Star Trek tricorder"- style tool for biosecurity and public health. Under this award, Ginkgo and its consortium partners are eligible to receive up to €24 million over the next 4 years.
RANGER seeks to transform the diagnostic landscape, enabling clinicians to diagnose complex respiratory conditions quickly and efficiently at the bedside with a device that allows for fully automated push-button sample preparation. With 6-hour turnaround time, hospitals could gain critical flexibility and optionality, allowing them to rapidly triage patients and reduce the burden of prolonged isolation, empirical therapies, and costly inpatient stays.
"Agnostic diagnostics" means the device wouldn't just look for a handful of known targets; it could sequence and identify virtually any respiratory pathogen, including emergent or engineered pathogens. This could significantly enhance pandemic preparedness. The program also offers the European Commission the option to procure 200 devices at preferred pricing, which could enable widespread and scalable deployment across EU/EEA healthcare systems.
The program is designed to be delivered in three phases. In the first phase, Ginkgo will work with a consortium of technology partners - Jumpcode, TGen, Bugseq, and Planet Innovation - to bring together existing technologies at different stages of technology readiness in one benchtop device. That device will then be taken through clinical trials in hospital settings in the EU in partnership with KU Leuven (Belgium), Karolinska University Hospital (Sweden), and Tartu University Hospital (Estonia) during the second phase of the program. Once clinical trials have been satisfactorily completed, Ginkgo will collaborate with medical device regulatory specialists at the QbD Group to secure EU certification and validation for certain analytes and sample types before bringing the RANGER device to market.
This collaboration aligns with HERA's mission to strengthen Europe's ability to prevent, detect, and rapidly respond to cross-border health emergencies, as it seeks to expand the availability of and access to key medical countermeasures. By supporting the development of near-patient sequencing capabilities, HERA and HaDEA aim to reduce diagnostic delays, enhance hospital triage and infection control, and provide a powerful early-warning tool against emerging pathogens. "Diagnostics as decision making tools are a key component of our toolbox to rapidly respond to health emergencies. The ability to quickly identify even previously unknown pathogens will be a critical step in reinforcing the EU's collective health resilience," said Laurent Muschel, Acting Director-General of HERA.
"HaDEA is committed to fostering innovative solutions that can strengthen Europe's capacity to prevent, detect, and respond to biological threats," said Marina Zanchi - Director of HADEA. "This project represents a leap forward in leveraging next-generation sequencing at the bedside, and we believe the collaborative approach taken by Ginkgo and its partners will greatly accelerate the path toward safer, more prepared healthcare systems across the region."
"This collaboration with HaDEA embodies our mission at Ginkgo Biosecurity to arm global healthcare systems with cutting-edge capabilities," said Matt McKnight, General Manager of Ginkgo Biosecurity. "Instead of waiting days to confirm a diagnosis, we want doctors to be able to run a sample through this machine and get results in about 6 hours. Ultimately, this means faster triage, better patient outcomes, and a more resilient frontline response to both seasonal viruses and future pandemics."
"We're moving toward a diagnostic model that's as easy and quick as scanning a patient's sample right on the spot," added Dr. Nita Madhav, Head of Epidemiology & Global Risk Analytics at Ginkgo Bioworks. "The European Commission's decision to fund this effort not only accelerates access to innovative medical countermeasures but also enables a step-change in how we detect and respond to novel respiratory pathogens. Our integrated approach—incorporating metagenomic sequencing, computational design, and predictive analytics—will help clinicians and public health leaders stay ahead of the curve."
"We're excited to be part of the RANGER consortium, which in partnership with Jumpcode's CRISPR-based technology, represents a significant advancement in diagnostic capabilities. By enabling faster and more comprehensive pathogen detection through our Cipher system, we're taking an important step forward in improving clinical diagnostics and enhancing pandemic preparedness," said Mike Salter, CEO of Jumpcode Genomics.
"TGen is focused on translating genomic findings to the clinic and the RANGER project and the outstanding collaborators involved are excellent vehicles for setting precedents in the translational research space" says Dr. Nicholas J. Schork, Professor at TGen whose lab published findings with Jumpcode on the initial version of the system to be developed and evaluated in the proposed research.
"BugSeq is thrilled to partner with RANGER consortium members to deploy our clinically-tailored bioinformatics platform to advance the use of rapid metagenomic sequencing for infectious disease diagnostics," said Sam Chorlton, CEO of BugSeq. "This collaborative effort to develop a seamless, end-to-end solution marks a significant step forward in accelerating the adoption of agnostic diagnostics and strengthening our ability to respond swiftly to public health emergencies."
"Planet Innovation is proud to be a part of the RANGER consortium, and will leverage its large product development and manufacturing capabilities in developing the highly innovative Cipher system. Planet Innovation has extensive experience in developing world-class platforms and we look forward to working alongside Jumpcode Genomics and all the consortium members in delivering a diagnostic solution that provides better patient outcomes, and a more resilient frontline response to both seasonal viruses and future pandemics," said Stuart Elliott, CEO of Planet Innovation.v
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