- First next-generation sequencing
platform to receive funding from BARDA
- Up to $51.9 million, contract to
support testing and FDA clearance of DNAe’s sequencing platform for
a series of applications
- Initial focus to address two of the
most significant threats to global health, antimicrobial resistance
and influenza
DNA Electronics (‘DNAe’), the inventors of semiconductor-based
next-generation DNA sequencing (NGS) technology and developers of a
revolutionary blood-to-result test for bloodstream infections,
announces that the Biomedical Advanced Research and Development
Authority (BARDA) a division of the Assistant Secretary for
Preparedness and Response (ASPR) in the U.S. Department of Health
and Human Services (HHS) has awarded the Company a contract worth
up to $51.9 million to develop its sequencing platform for rapid
diagnosis in two key applications; antimicrobial resistant
infections and influenza.
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Professor Chris Toumazou, Founder and
Executive Chairman DNAe, at the Company's London R&D
facilities. Copyright DNAe. (Photo: Business Wire)
Genomic information derived from DNA sequencing is transforming
many areas of medicine. This is the first NGS platform supported by
BARDA, with game-changing potential in the diagnosis and treatment
of infectious diseases.
The Centers for Disease Control and Prevention (CDC) have
estimated that more than 2 million people per year in the U.S.
suffer antimicrobial resistant infections resulting in 23,000
deaths. The CDC also predicts that a flu pandemic could result in
between 89,000 and 207,000 deaths in the U.S. and could cost the
economy $71.3-166.5 billion.
The contract for the project entitled PISCES (Pathogen
Identification from Specimen, via Capture Extraction and
Sequencing) will enable DNAe to complete the development and
validation of its ground-breaking Genalysis® platform and support a
series of applications to the U.S. Food and Drug Administration for
marketing clearance.
The Genalysis® platform will combine the ability to sequence the
DNA of the infectious organism, in a sealed microchip based system,
direct from clinical specimen, with analysis that enables
actionable identification of the disease agent within a few hours,
a key requirement in the effective treatment of infectious
diseases.
DNAe’s first product will be a rapid blood-to-result diagnostic
system to meet an unmet need in the treatment of serious
bloodstream infections leading to sepsis. Sepsis is an area of very
high unmet medical need, responsible for over 200,00
deaths per annum in the US, more than prostate cancer, breast
cancer and AIDS combined1. In late stage development and testing,
the new system is set for commercial launch in 2018.
In 2014, BARDA awarded a $21.5 million, contract to DNAe’s US
operation (then called nanoMR, Inc.) to develop an automated sample
preparation system that could reduce the time needed to test for
bloodstream infections and biothreat agents such as anthrax from
days to hours. DNAe acquired nanoMR in January 2015 to complete the
workflow of its sample-to-result solution by combining nanoMR’s
novel Pathogen Capture System, which extracts and concentrates
pathogens, such as bacteria or fungi directly from a raw blood
sample, with its Genalysis® technology.
Sam Reed, President, U.S. Office, DNAe, based in Washington DC,
and who is leading DNAe’s sequencing program commented: “Our
platform is truly revolutionary as it brings a powerful
sequencing-based diagnostic capability into a rapid, user-friendly
format. Importantly the platform can be operated by users who are
not specially-trained in sequencing, enabling it to be used in a
wide range of near-to-patient clinical environments where
sequencing has not been possible before. Unlike existing sequencing
devices, the platform operates ‘push button’ directly from raw
clinical specimens such as blood or swabs, delivering a
clinically-relevant report for the physician.”
Bloodstream infections afflict over 1 million patients per year
in the US alone, making it the single most expensive disease in
terms of total healthcare expenditure2. DNAe’s Genalysis® platform
will revolutionize care by very rapidly identifying the causative
pathogens and their antibiotic resistance profile from a wide range
of potential causes. This has the potential to drive reduced
mortality, reduced length of stay in critical care, reduced
healthcare expenditure, and improved management of antibiotics. In
influenza testing, the platform has the potential to ultimately
identify the strain subtype and antiviral resistance markers,
guiding antiviral usage in critical patients or for management of
patients during a pandemic.
Dr Steve Allen, CEO DNAe Group Holdings said: “DNA
sequencing-based tests that can rapidly provide accurate diagnostic
information on infectious diseases will be a game-changer in terms
of how clinicians treat infectious diseases in the future. It will
enable the choice of treatment to be highly specific and tailored
to the causative pathogens. Antimicrobial resistance and the threat
of an influenza pandemic are two of the most critical threats to
human life, and areas of huge unmet need. The support and
cooperation of the U.S. Government will be instrumental in our
mission to provide rapid diagnostics to support healthcare
professionals, enabling a more effective public health response to
these crises.”
Semiconductor-based DNA sequencing was invented by DNAe’s
Founder, Executive Chairman, and Regius Professor at Imperial
College London (Department of EEE), Professor Chris Toumazou and
his group at Imperial. A highly acclaimed serial entrepreneur, this
invention has earned him the UK Institution of Engineering and
Technology (IET)’s highest honour, the Faraday Medal and the
European Patent Office’s prestigious Inventor of the Year Award for
Research in 2014, and the Gabor Medal of the Royal Society in 2013.
DNAe owns and applies his patented technology to create rapid
diagnostics that address critical unmet needs in healthcare
applications. The semiconductor sequencing technology is licensed
to Thermo-Fisher for research use.
Professor Toumazou, DNAe said: “This collaboration demonstrates
the suitability of DNAe’s NGS-based platform to address a range of
clinical needs, demonstrated by the applications in antimicrobial
resistance and influenza testing, where there is a very high unmet
need.”
—Ends—
About DNAe – www.dnae.com
DNAe is commercialising its pioneering semiconductor DNA
analysis technology for healthcare applications where rapid
near-patient live diagnostics is needed to provide actionable
information to clinicians, saving lives by enabling the right
treatment at the right time.
In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics
Inc.), a developer of a novel system for rapid isolation of rare
cells in the bloodstream. DNAe is developing a complete sample to
result genomic analysis platform combining DNA Electronics Inc.’s
Pathogen Capture System with its own Genalysis® semiconductor DNA
analysis technology. Built into a compact device for use at the
point of need, the system will diagnose accurately and rapidly what
infection a patient has, providing the clinician with actionable
information to help select the appropriate antibiotics to treat the
disease.
DNAe’s initial focus is on infectious disease diagnostics, where
speed and DNA-specific information can make the difference between
life and death. DNAe’s first product, will be a diagnostic test for
bloodstream infections for use in the management and prevention of
sepsis.
A private company, with operations in London, UK, and Carlsbad,
CA and Washington DC, USA, DNAe has strong financial backing from
its investors, including major shareholder Genting Berhad, a
Malaysian-based global investor with a growing portfolio of
cutting–edge life sciences companies.
References
1. World Sepsis Day factsheet, Global Sepsis Alliance:
http://www.world-sepsis-day.org/CONTENTPIC/2015_WSD_FactSheet_long_English.pdf
2. Celeste M. Torio, Ph.D., M.P.H. and Roxanne M. Andrews,
Ph.D.: National Inpatient Hospital Costs: The Most Expensive
Conditions by Payer, 2011.
http://www.hcup-us.ahrq.gov/reports/statbriefs/sb160.pdf
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DNAeDr Steve Allen, Chief Executive Officer (London,
UK)Tel: +44 (0)20 7036 2100orSam Reed, President, U.S. Office
(Washington, USA)Tel: +1 202 779 2640orInstinctif Partners
(media relations)Sue Charles / Jen Lewis / Alex BannisterTel:
+44 (0)20 7457 2020Email: DNAe@instinctif.com