Ginkgo Bioworks Partners with HaDEA in Up to €24 Million Consortium Project to Deliver Next-Generation 'Agnostic Diagnostics' for Respiratory Viruses at the Point of Care

Rhea-AI Summary

Ginkgo Bioworks (NYSE: DNA) has announced a partnership with the European Health and Digital Executive Agency (HaDEA) in a consortium project worth up to €24 million over 4 years. The project, named RANGER (RApid Next Generation Sequencing for Effective Medical Response), aims to develop a rapid point-of-care diagnostic solution for respiratory viruses.

The initiative will create a device capable of identifying virtually any respiratory pathogen through metagenomic next-generation sequencing (mNGS) with a 6-hour turnaround time. The program includes an option for the European Commission to procure 200 devices at preferred pricing.

The project will be executed in three phases, involving technology development with partners Jumpcode, TGen, Bugseq, and Planet Innovation, followed by clinical trials in EU hospitals, and finally EU certification. The consortium includes partnerships with KU Leuven, Karolinska University Hospital, and Tartu University Hospital for clinical trials.

Positive

• Secured up to €24 million in funding over 4 years
• Potential procurement agreement for 200 devices with European Commission
• Strategic partnerships with multiple technology companies and research institutions
• Development of innovative diagnostic technology with 6-hour turnaround time

Negative

• Product development and certification process could take up to 4 years
• Success dependent on passing clinical trials and regulatory approval

Insights

Biosecurity Technology Analyst

This €24 million EU collaboration marks a strategic expansion of Ginkgo's biosecurity capabilities into the lucrative €4.4 billion European molecular diagnostics market. The RANGER project's development of an 'agnostic' diagnostic platform represents a significant technological leap, combining metagenomic sequencing with rapid turnaround times that could revolutionize respiratory pathogen detection.

The consortium structure is particularly noteworthy, as it brings together complementary technologies: Jumpcode's CRISPR-based technology, TGen's clinical expertise, BugSeq's bioinformatics, and Planet Innovation's manufacturing capabilities. This integrated approach significantly de-risks development while accelerating time-to-market. The potential procurement of 200 devices by the European Commission provides a clear initial market opportunity and validation.

The 6-hour turnaround time for results could generate substantial cost savings for healthcare systems by reducing unnecessary isolation periods and empirical treatments. Current molecular diagnostic methods typically require 24-72 hours for results, making this a potentially disruptive advancement. The ability to detect novel and engineered pathogens also positions this technology as a critical tool for biosecurity and pandemic preparedness.

The three-phase development approach, culminating in EU certification, provides a clear pathway to commercialization. The involvement of prestigious medical institutions like KU Leuven and Karolinska University Hospital for clinical trials adds credibility and reduces regulatory risks. This structured approach, combined with the EU's commitment through HERA, suggests a high probability of successful market entry by 2029.

International consortium to develop rapid metagenomic NGS solutions that can identify known and novel respiratory pathogens, reduce time-to-diagnosis, and enhance hospital decision-making and public health preparedness

BOSTON, Feb. 20, 2025 /PRNewswire/ -- 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.

To learn more about how you can benefit from Ginkgo Biosecurity, please visit our website at https://biosecurity.ginkgo.bio.

About Ginkgo Bioworks

Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo Biosecurity is building and deploying the next-generation infrastructure and technologies that global leaders need to predict, detect, and respond to a wide variety of biological threats. For more information, visit ginkgobioworks.com and ginkgobiosecurity.com, read our blog, or follow us on social media channels such as X (@Ginkgo and @Ginkgo_Biosec), Instagram (@GinkgoBioworks), Threads (@GinkgoBioworks), or LinkedIn.

GINKGO BIOWORKS INVESTOR CONTACT:
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Forward-Looking Statements of Ginkgo Bioworks

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the capabilities and potential success of the partnership and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) volatility in the price of Ginkgo's securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, and changes in laws and regulations affecting Ginkgo's business, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, (iii) the risk of downturns in demand for products using synthetic biology, (iv) the uncertainty regarding the demand for passive monitoring programs and biosecurity services, (v) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, (vi) the outcome of any pending or potential legal proceedings against Ginkgo, (vii) our ability to realize the expected benefits from and the success of our Foundry platform programs, (viii) our ability to successfully develop engineered cells, bioprocesses, data packages or other deliverables, and (ix) the product development or commercialization success of our customers. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (the "SEC") on February 29, 2024, Ginkgo's most recent quarterly report on Form 10-Q, and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

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SOURCE Ginkgo Bioworks

FAQ

What is the value of Ginkgo Bioworks' (DNA) RANGER project with HaDEA?

The RANGER project is valued at up to €24 million over 4 years, funded through the EU4Health programme.

How long will it take for DNA's diagnostic device to process results?

The diagnostic device being developed by Ginkgo Bioworks will provide results within 6 hours.

How many diagnostic devices could the European Commission purchase from DNA?

The European Commission has the option to procure 200 devices at preferred pricing.

Which hospitals are partnering with Ginkgo Bioworks (DNA) for clinical trials?

KU Leuven (Belgium), Karolinska University Hospital (Sweden), and Tartu University Hospital (Estonia) are partnering for clinical trials.

What technology companies are part of DNA's RANGER consortium?

The consortium includes Jumpcode, TGen, Bugseq, and Planet Innovation as technology partners.