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:
investors@ginkgobioworks.com
GINKGO BIOWORKS MEDIA
CONTACT:
press@ginkgobioworks.com
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
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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
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as of the date they are made. Readers are cautioned not to put
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future events, or otherwise. Ginkgo does not give any assurance
that it will achieve its expectations.
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