2018

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    Nov 2, 2018 | Breakthrough in Rapid Diagnostic for Antimicrobial Resistance

    Breakthrough in Rapid Diagnostic for Antimicrobial Resistance

     

    DNAe achieves major milestone in a novel clinical sequencing platform, successfully

    completing the first phase of its $51.9 million contract with US government’s BARDA

     

    London, UK and Carlsbad, CA, USA – 2 November 2018 – A rapid new diagnostic platform that harnesses the power of semiconductor DNA sequencing, promises to revolutionise the ability of physicians to treat antimicrobial resistant infections.

     

    DNA Electronics (‘DNAe’), the company behind the platform, today announces that it has successfully completed the first phase of its contract that could be worth up to $51.9 million, with U.S. government agency, the Biomedical Advanced Research and Development Authority (BARDA)*. The contract, initially awarded in September 2016, supports the development of DNAe’s next generation sequencing (NGS) platform for rapid diagnosis of antimicrobial resistant infections and influenza. BARDA has already approved the next stage of the contract, which is currently underway.

     

    Using technologies that will ultimately be suitable for a rapid user-friendly test, DNAe has successfully sequenced the DNA of bacteria directly from an unprocessed blood sample. This has not been possible with any sequencing technologies to date, which have typically entailed long turnaround times and been relegated to specially-trained users in sophisticated labs. This breakthrough will enable hospitals to precisely identify the infectious agent and any resistance to antibiotics. This intelligence is vital, helping physicians choose targeted treatments that will be most successful in treating the infection.

     

    “This will help to address the increase in antimicrobial resistance by fundamentally changing the way antibiotics are prescribed” said Professor Chris Toumazou, the inventor of semiconductor sequencing technology, DNAe’s Executive Chairman and Regius Professor of Engineering at Imperial College London (Department of EEE). He added “The relative speed, simplicity, scalability and cost-effectiveness of semiconductor sequencing allow it to be used in a much wider range of settings than previously possible for DNA sequencing, and make it particularly suited to application in diagnosis.”

     

    Sam Reed, President, U.S. Office said: “We have completely redesigned the DNA sequencing process to allow it to be used for rapid diagnosis in hospitals, closer to the patient, and operated by users who are not specially-trained. It’s a completely different type of workflow than has been used before, so successfully achieving this latest milestone was a real ‘eureka moment’. We now have proof that this new approach works – all we need to do is integrate the steps into one box. BARDA’s support is enabling us to fast track this program and address the global crisis of antimicrobial resistance.”

     

    BARDA has already approved DNAe to progress to the second phase of the contract, releasing $10.98m for the development of an alpha prototype. DNAe has also increased its engagement with clinicians and end users, having brought on board an expert clinical advisory board in 2017.

     

    Each year in the United States alone, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections.1 In addition, across Europe, an estimated 25,000 people die each year as a result of hospital infections caused by antibiotic resistant Escherichia coli, Klebsiella pneumoniae, Enterococcus faecium, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus (MRSA), adding over £1 billion to hospital treatment and societal costs. The problem is getting worse and unless tackled antibiotic resistance could result in 10 million deaths per year globally by 2050, costing an estimated £66 trillion.2

     

    Dr Steve Allen, CEO DNAe Group Holdings commented, “Our next-generation sequencing-based diagnostic platform has been carefully designed with the end users in mind, and we have been interacting with clinicians from the outset to get feedback at every stage of development to make sure it meets their needs. We are realising our vision of bringing DNA sequencing into the clinic, so that patients can really benefit from its accuracy and speed of diagnosis which should make such a difference to getting the most effective treatment to patients.”

     

    DNAe’s genomic analysis technologies are based on its invention of semiconductor DNA sequencing, a specific type of next-generation sequencing that works by using a silicon chip to detect the ions released as a DNA strand is built up molecule by molecule.  DNAe has three new patent applications from the first phase of the project alone.

     

    Professor Chris Toumazou concluded that, “Bringing genomics and DNA sequencing closer to the patient will transform the treatment pathway by arming doctors with the information that they need to make an evidence-based treatment decision. The continued support of BARDA will be instrumental in our mission to provide rapid diagnostics to support healthcare professionals globally.”

     

    *BARDA is a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

     

    —Ends—

     

    About DNAe – www.dnae.com

     

    DNAe is commercializing its pioneering semiconductor DNA sequencing 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 LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.


    DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® launches with the LiDia® Bloodstream Infection (BSI) test, a ground-breaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. 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.

     

    In October 2016, 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) awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and pandemic influenza.

     

    A private company, with bases in London, UK and Carlsbad, CA, 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. US Centers for Disease Control and Prevention website.

    https://www.cdc.gov/drugresistance/threat-report-2013/index.html

    2. UK Government Health matters antimicrobial resistance website.

    https://www.gov.uk/government/publications/health-matters-antimicrobial-resistance/health-matters-antimicrobial-resistance

     

    Contact Details

     

    DNAe

    Dr Steve Allen, Chief Executive Officer Tel: +44 (0)20 7036 2100

    Sam Reed, President, US Office (Washington, D.C., USA) Tel:  +1 202 779 2640

     

    Instinctif Partners (media relations)

    Tel: +44 (0)20 7457 2020

    Sue Charles / Ashley Tapp / Alex Bannister

    Email: DNAe@instinctif.com

     

     

     

     

     

     

     

     

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    Oct 16, 2018 | DNAe Wins OBN Award for Best Diagnostic Medtech Company

    DNAe Wins OBN Award for Best Diagnostic Medtech Company

     

    London, UK and Carlsbad, CA, USA – 16 October 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, was named ‘Best Diagnostic Medtech Company’ at the 2018 OBN Awards.

     

    Marking its 10th anniversary, the prestigious OBN Awards recognize and celebrate innovation and achievement of leading companies in the Life Sciences industry.

     

    DNAe was chosen by a panel of independent expert judges, representing a diverse spectrum of UK and global life sciences stakeholders. DNAe beat the other finalists, Oxford Cancer Biomarkers, Owlstone Medical and Inivata, to the award. DNAe was recognized for its pioneering semiconductor DNA analysis and sample preparation1 technologies that underlie its breakthrough direct-from-blood, cartridge-based diagnostic in development, LiDia® BSI1,2, as well as the developmental progress and disruptive potential of the LiDia® BSI method.

     

    Jonathan Rohll, Head of Business Information at OBN said: “DNAe really caught the eye of many of our judges for addressing a clear unmet need with their novel microchip-based, fast and simple technology platform that has huge potential in the early diagnosis of sepsis and other acute conditions. We would like to congratulate them on winning the Best Diagnostic Medtech Company category at the 2018 OBN Awards.”

     

    Accepting the award at the OBN Awards ceremony on 11 October at the Examination Schools of the University of Oxford, Oxford, UK, were Nick McCooke, Chief Business Officer of DNAe, and Dr Nour Shublaq, DNAe’s European Product Manager. McCooke said: “We are very proud to be named as Best Diagnostic MedTech Company at the 2018 OBN Awards. Identification of bloodstream infections using current standard-of-care culture-based diagnostics is slow, and testing is often carried out at specialist laboratories away from the patient. Meanwhile, treatment is typically empirical, impacting survival rates and hospital stay negatively. DNAe’s first generation platform and revolutionary test, currently in development, will enable rapid diagnosis of sepsis-causing bloodstream infections closer to the frontline of care, and operated by non-expert end users. The potential impact to patients and institutions from timely evidence-based treatment owing to our approach is considerable.”

     

    DNAe’s first generation platform utilizes amplification-based detection. The LiDia® BSI test promises to revolutionize the ability of physicians to treat antimicrobial resistant infections by identifying the causative pathogen, including key antimicrobial resistance markers within two to three hours, directly from a whole blood sample.

     

    DNAe’s Executive Chairman, Professor Chris Toumazou, co-inventor of several DNA semiconductor technologies used in the platform, and Regius Professor of Engineering at Imperial College London, commented: “This is another outstanding achievement underscoring our innovative technologies, determination and inspirational efforts to transform bloodstream infection diagnosis with fast and simple semiconductor-based diagnostics.”

     

    Dr Steve Allen, CEO of DNAe Group Holdings commented: “We are delighted that DNAe is named as Best Diagnostic MedTech Company at the 2018 OBN Awards and we thank the Expert Judges for this special honor. Being recognized in short order in two separate prestigious industry award programs, now by the OBN Awards and last month by the MedTech Insight Awards, follows a successful first half of the year for DNAe. In April, at the ECCMID 2018 congress, we previewed a demonstration of the blood-to-result workflow of LiDia® BSI for the first time at our booth, and presented data that demonstrated the ability of the LiDia® BSI method to detect pathogens and antibiotic resistance in samples from patients who had received antibiotic therapy, within a significantly shorter period than standard-of-care blood culture testing. We look forward to making further announcements in due course.”

     

    Last month, DNAe was also named ‘Most Innovative Team or Innovator of the Year’ at the Inaugural Medtech Insight Awards in Philadelphia, USA. More details can be found, here.

     

    References

     

    1. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.
    2. Test in development. For Research Use Only. Not for use in diagnostic procedures.

     

     

    —Ends—

     

    About DNAe – www.dnae.com

     

    DNAe is developing its pioneering semiconductor DNA sequencing 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 LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

     

    DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. 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.

     

    A private company, with bases in London, UK and Carlsbad, CA, 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.

     

    Contact Details

     

    DNAe

    Dr Steve Allen, Chief Executive Officer, DNAe Group

    Tel: +44 (0)20 7036 2100

     

    Instinctif Partners (media relations)

    Tel: +44 (0)20 7457 2020

    Sue Charles / Ashley Tapp / Alex Bannister

    Email: DNAe@instinctif.com

     

     

     

     

     

     

     

     

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    Sept 27, 2018 | DNAe Wins Inaugural 2018 Medtech Insight Top Innovator Award

    DNAe Wins Inaugural 2018 Medtech Insight Top Innovator Award

     

    London, UK and Carlsbad, CA, USA – 27 September 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, was named ‘Most Innovative Team or Innovator of the Year’ at the inaugural 2018 Medtech Insight Awards.

     

    The Most Innovative Team or Innovator of the Year award recognizes the medical technology team that has contributed most significantly to the device and diagnostic space between 1 January 2017 and 31 May 2018. DNAe beat the other finalists, electroCore, Eyenovia, Innoventions, MediSieve, Owlstone Medical, PolarityTE, and The Trendlines Group Labs Team to the award. DNAe was chosen by the expert judges for its development achievements during the qualifying period and towards realizing a rapid, user-friendly, direct-from-sample diagnostic platform based on its semiconductor sequencing technology1.

     

    DNAe, a spin-out of Imperial College London, fundamentally redesigned DNA sequencing from the ground up, using novel technologies that will be suitable for rapid diagnosis closer to the frontline of care and operable by non-specialist end users. The Company was judged to be the high performing team that has been most successful in reaching its goals, adopted innovative working practices, achieved major milestones within expected timelines, and contributed to the advancement of medical technology for unmet medical needs.

     

    Accepting the award at the Medtech Insight Awards ceremony on 23 September at the Kimpton Hotel Monaco in Philadelphia, USA, Sam Reed, Program Director and President of DNAe’s U.S. Office, said: “Winning this award is a great honor, and a testament to our whole team’s dedication and performance. The ultimate goal is to enable sequencing to solve urgent unmet clinical needs, including antimicrobial resistance and influenza. We strongly believe that innovation is fundamental to achieving our mission to enable DNA sequencing to be used in hospitals, much closer to the frontline of care than it is used today.”

     

    DNAe’s sequencing-based diagnostic platform promises to revolutionize the ability of physicians to treat antimicrobial resistant infections by rapidly identifying the infectious agent including any antimicrobial resistance. This has potential to enable swifter treatment of infections with targeted therapeutics to improve patient outcomes and address a critical unmet need.

     

    DNAe’s sequencing platform in development is funded in part by the Biomedical Advanced Research and Development Authority (BARDA)1, who awarded DNAe a contract worth up to $51.9 million, if all options are exercised, to develop its next generation sequencing platform for rapid diagnosis of antimicrobial resistant infections and influenza.

     

    Dr Steve Allen, CEO of DNAe Group Holdings, commented: “The first two years of our contract with BARDA to develop a rapid, user-friendly, direct-from-sample diagnostic sequencing platform have been highly productive. We are delighted that our technologies and the inspirational thinking of our talented scientists and engineers have been recognized with this prestigious award.”

     

    In parallel to its next-generation sequencing based platform, DNAe is developing a diagnostic which uses DNA amplification (PCR) and semiconductor technology, to detect pathogens and key resistance markers. Also operating directly from blood, this first-generation system will provide actionable results within 2-3 hours. The test, called LiDia® Bloodstream Infection (BSI)2,3, has the potential to transform the management of sepsis.

     

    Professor Chris Toumazou, inventor of DNAe’s semiconductor sequencing technology, DNAe’s Executive Chairman and Regius Professor of Engineering at Imperial College London (Department of EEE) added, “Bringing genomics and DNA sequencing for rapid diagnosis closer to the patient will transform the treatment pathway by arming doctors with actionable information that they need to make a timely, appropriate, and evidence-based treatment decision. I am delighted that our achievements and potential have been recognized in this award.”

     

    The Medtech Insight Awards Judging Panel commented, “DNAe is developing a next-generation sequencing platform for rapid diagnosis of antimicrobial resistant infections and influenza. An outstanding advancement in one of the most critical health issues today. The organized teamwork, with multi-disciplinary expertise, is very impressive. This company has accomplished a great deal.”

     

    1 This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600017C.

    2 Test in development. For Research Use Only. Not for use in diagnostic procedures

    3 This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.

     

     

    —Ends—

     

    About DNAe – www.dnae.com

     

    DNAe is developing its pioneering semiconductor DNA sequencing 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 LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

     

    DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. 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.

     

    A private company, with bases in London, UK and Carlsbad, CA, 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.

     

    Contact Details

     

    DNAe

    Dr Steve Allen, Chief Executive Officer, DNAe Group

    Tel: +44 (0)20 7036 2100

     

    Instinctif Partners (media relations)

    Tel: +44 (0)20 7457 2020

    Sue Charles / Ashley Tapp / Alex Bannister

    Email: DNAe@instinctif.com

     

     

     

     

     

     

     

     

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    August 15, 2018 | DNAe Chosen as Best Diagnostic Medtech Company Finalist in the 2018 OBN Awards

    DNAe Chosen as Best Diagnostic Medtech Company Finalist in the 2018 OBN Awards

     

    London, UK and Carlsbad, CA, USA – 15 August 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, today announced that it has been shortlisted as a finalist for the 2018 OBN Awards, in the category ‘Best Diagnostic Medtech Company’. These prestigious industry award nominations recognise and celebrate leading companies in the Life Sciences industry.

     

    The finalists were judged by a panel of independent experts, representing a diverse spectrum of UK and global life sciences stakeholders.

     

    DNAe has been selected for its pioneering semiconductor-based genomic analysis and sample preparation1 technology platforms that underlie its game-changing diagnostic in development, LiDia® BSI1,, which is a rapid direct from blood test for bloodstream infections (BSI) that can lead to sepsis. DNAe’s LiDia® BSI1,2 diagnostic promises to revolutionise the ability of physicians to treat antimicrobial resistant infections by rapidly identifying the infectious agent including key antimicrobial resistance markers within 2 to 3 hours, directly from sample presentation.

     

    Sepsis is a major global healthcare priority, with an estimated 31.5 million bloodstream infection cases occurring annually worldwide, resulting in approximately 5.3 million deaths3. In the US and Europe, sepsis is responsible for an estimated 2.5 million cases4, and in the US, sepsis is the most expensive condition to treat accounting for nearly $27 billion annual cost to the healthcare system5. In 2017, the WHO adopted a resolution on improving the prevention, diagnosis and management of sepsis6.

     

    For every hour a patient in septic shock does not receive the appropriate antibiotic, there is an 8% reduction in survival rate7. Pathogen identification using current standard-of-care culture-based diagnostics takes 2-6 days and involves sending samples offsite to specialist laboratories, during which time patients typically receive empirical treatment impacting survival rates and hospital stay negatively. Designed to be used in hospitals, much closer to the frontline of care and operated by non-specialist end users, LiDia® BSI has the potential to enable swifter treatment of infections with targeted therapeutics to improve patient outcomes and address a critical unmet need.

     

    Dr Steve Allen, CEO of DNAe Group Holdings, commented: “We are delighted to receive recognition from the Life Sciences industry as a Best Diagnostic MedTech Company finalist, and we are tremendously proud that DNAe has been shortlisted for two prestigious awards in short order8. These nominations help shine light on our key advances to the diagnostic field, and are a testament to our innovative technologies as well as the commitment and excellence of our entire team. We’re developing LiDia® BSI to address the pressing demand for earlier diagnosis of bloodstream infections in hospitals closer to the patient, and assisting swifter evidence-based selection of targeted treatment.”

     

    Dr John Harris, CEO of OBN (UK) said: “We received the highest number of qualifying entries for the OBN Awards this year, up a staggering 40% on last year’s total. The standard of entries across all categories was extremely high and we are encouraged about the level of exciting new innovation and positive growth we are seeing in UK Life Sciences. We look forward to celebrating with all our finalists on 11 October at the Examination Schools in Oxford.”

     

    A panel of independent expert judges will further assess the finalists for each category and the winners will be announced on 11 October at the OBN Awards ceremony in Oxford, UK. The occasion also marks the 10th Anniversary of the OBN Awards, celebrating 10 years of Innovation and Achievement in the Life Sciences Industry.

     

    The full list of award categories and finalists can be found online, here.

     

    —Ends—

     

    About DNAe – www.dnae.com

     

    DNAe is developing its pioneering semiconductor DNA sequencing 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 LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

     

    DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. 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.

     

    A private company, with bases in London, UK and Carlsbad, CA, 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.

     

    Contact Details

     

    DNAe

    Dr Steve Allen, Chief Executive Officer, DNAe Group

    Tel: +44 (0)20 7036 2100

     

    Instinctif Partners (media relations)

    Tel: +44 (0)20 7457 2020

    Sue Charles / Ashley Tapp / Alex Bannister

    Email: DNAe@instinctif.com

     

     

    1This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.

    2Test in development. For Research Use Only. Not for use in diagnostic procedures.

    3Fleischmann C et al. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med 2016; 193(3): 259-72.

    4Angus D. C. et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Critical care medicine 2001; 29(7): 1303-10.

    5Bloomberg, July 2017, https://www.bloomberg.com/news/articles/2017-07-14/america-has-a-27-billion-sepsis-crisis

    6Reinhart K et al. Recognizing Sepsis as a Global Health Priority — A WHO Resolution N Engl J Med 2017 (perspective); 377:414-417: doi: 10.1056/NEJMp1707170.

    7McGregor C Improving time to antibiotics and implementing the "Sepsis 6" BMJ Open Quality 2014;2:u202548.w1443. doi: 10.1136/bmjquality.u202548.w1443

    8DNA Electronics Press Release 08 August 2018, “DNAe Named as Top Innovator Finalist in the Inaugural 2018 Medtech Insight Awards”, https://www.dnae.com/assets/8-aug-2018-dnae_medtech-insight-shortlisting_press-release-final_2.pdf

     

     

     

     

     

     

     

  •  

    August 8, 2018 | DNAe Named as Top Innovator Finalist in the Inaugural 2018 Medtech Insight Awards

    DNAe Named as Top Innovator Finalist in the Inaugural 2018 Medtech Insight Awards

     

    London, UK and Carlsbad, CA, USA – 8 August 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, today announced that it has been shortlisted for the inaugural 2018 Medtech Insight Awards, in the category ‘Most Innovative Team or Innovator of the Year’.

     

    The finalists were judged by a panel of independent experts, who are highly regarded within the medtech sector. DNAe was selected in recognition of its development achievements in the qualifying period 1 January 2017 - 31 May 2018, and towards realizing a rapid, user-friendly, direct-from-sample diagnostic platform based on its semiconductor sequencing technology.1

     

    Each year in the US, at least two million people become infected with bacteria resistant to antibiotics and at least 23,000 people die2. The problem is getting worse and unless tackled, antibiotic resistance could result in ten million extra deaths each year and cost the global economy an estimated $100 trillion by 20503. Pathogen identification using current standard-of-care culture-based diagnostics is slow. Patients typically receive empirical treatment, given without knowledge of the underlying cause of their illness, impacting survival rates and hospital stay negatively.

     

    The DNAe platform in development will be used in hospitals, much closer to the frontline of care than sequencing is used today, for a range of urgent clinical applications. It is funded in part by the Biomedical Advanced Research and Development Authority (BARDA)* who awarded DNAe a contract worth up to $51.9 million, if all options are exercised, to develop the next generation sequencing platform for rapid diagnosis of antimicrobial resistant infections and influenza.

     

    Dr Steve Allen, CEO of DNAe Group Holdings, commented: “We are extremely proud to be chosen as one of the top medical technology innovators of 2018. We are delighted that the technologies we have invented, and the inspirational thinking and diligence of our talented scientists and engineers have come together to deliver this success. Diagnostics are a key part of the solution to tackling the growing global health crisis of antimicrobial resistance. We are committed to transforming infectious disease diagnosis by redesigning DNA sequencing from the ground up to enable its use closer to the frontline of care.”

     

    The Most Innovative Team or Innovator of the Year category recognizes high performing medical technology teams who have contributed significantly to the device and diagnostic space. The award winner will be the team deemed by the expert judges most successful in having reached its goals, adopted innovative working practices, achieved major milestones within expected timelines, and contributed to the advancement of medical technology for unmet medical needs.

     

    The full list of Medtech Insight Award finalists can be found online, here. The winners will be announced at the award ceremony to be held on the evening of 23 September at the Kimpton Hotel Monaco in Philadelphia, USA.

     

    In parallel to its next-generation sequencing based platform, DNAe is developing a diagnostic which uses DNA amplification (PCR) and semiconductor technology, to detect pathogens and key resistance markers. Also operating directly from blood, this first-generation system will provide actionable results within 2-3 hours. The test, called LiDia® Bloodstream Infection (BSI), has the potential to transform the management of sepsis.

     

    *BARDA is part of the office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

     

    1This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600017C.

    2https://www.cdc.gov/drugresistance/index.html (last accessed 03 August 2018).

    3https://amr-review.org/sites/default/files/AMR%20Review%20Paper%20-%20Tackling%20a%20crisis%20for%20the%20health%20and%20wealth%20of%20nations_1.pdf (last accessed 03 August 2018).

    —Ends—

     

    About DNAe – www.dnae.com

    DNAe is developing its pioneering semiconductor DNA sequencing 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 LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

     

    DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. 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.

     

    A private company, with bases in London, UK and Carlsbad, CA, 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.

     

    Contact Details

     

    DNAe

    Dr Steve Allen, Chief Executive Officer, DNAe Group

    Tel: +44 (0)20 7036 2100

     

    Instinctif Partners (media relations)

    Tel: +44 (0)20 7457 2020

    Sue Charles / Ashley Tapp / Alex Bannister

    Email: DNAe@instinctif.com

     

     

     

     

     

     

  •  

    April 24, 2018 | Rapid Detection of Pathogen and Antibiotic Resistance with DNAe’s LiDia® Bloodstream Infection (BSI) Technology

    Rapid Detection of Pathogen and Antibiotic Resistance with DNAe’s LiDia® Bloodstream Infection (BSI) Technology

     

    •  Data presented at 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Madrid, Spain
    •  DNAe’s LiDia® BSI method accurately detected pathogen and antibiotic resistance in samples collected from patients receiving antibiotic therapy
    • Pathogen detected in 9 samples that were negative in the paired blood culture but confirmed with other microbiological data
    • Time from specimen collection to result for the LiDia® BSI method was just a few hours, compared to 2-5 days with blood culture
    • Study conducted in collaboration with Mayo Clinic and University New Mexico Health Sciences Center

     

    London, UK and Carlsbad, CA, USA – 24 April 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, announces new data generated with its LiDia® Bloodstream Infection (BSI) technology, currently in development. The LiDia® BSI method was demonstrated to detect pathogen and antibiotic resistance in samples collected from patients after receiving antibiotic therapy. Time to detection by the LiDia® BSI method was significantly shorter (hours vs. days) compared to standard-of-care blood culture testing.

     

    Early treatment with broad-spectrum antibiotics is critical for patients with BSIs. However, antibiotics can affect the growth of any bacteria present in a sample and can therefore lead to false negatives if blood culture is used for diagnosis once a patient has begun antibiotic treatment. The technology used by LiDia® BSI can detect the presence of pathogens without interference by antimicrobial therapy.

     

    Pathogens and antibiotic resistance detected by the LiDia® BSI method in samples collected from patients with suspected or confirmed BSI showed concordance with blood culture results in 31 patients pre-treated with antibiotics. The LiDia® BSI method also detected pathogens in a further nine samples, where blood culture collected concurrently produced a negative result.  The LiDia® BSI results in these samples matched earlier blood culture results from the same patients. Time to result for the LiDia® BSI method was just a few hours, whereas blood culture results were available 2-5 days after specimen collection.

     

    Clinical specimens were collected with consent from two sites, the Mayo Clinic (Rochester, MN, USA) and the University of New Mexico Health Sciences Center (Albuquerque, NM, USA). The largest numbers of patients with positive blood cultures in the DNAe study came from the Medical Intensive Care Unit (MICU) (25%), surgical wards (20%) and general medical wards (17.5%), followed by Emergency Departments (ED) (12.5%). The most frequently encountered microorganisms were Escherichia coli, Staphylococcus aureus and Klebsiella pneumoniae.

     

    Once a specific diagnosis is confirmed, patients can be treated with a more targeted antibiotic. Rapid and accurate identification of the pathogen would enable physicians to prescribe targeted treatment faster, potentially improving the patient’s prognosis and reducing healthcare costs. It could also help to reduce the spread of antimicrobial resistance by preventing the over-use of broad spectrum antibiotics.

     

    David Davidson, Chief Scientific Officer at DNAe and author on the poster said, “The study demonstrates the real-world potential of LiDia® BSI, and its ability to rapidly identify infectious agents even in patients who are already being treated with antibiotics. The test could help clinicians determine if patients already being treated with antibiotics are on the correct drug and may enable treatment with targeted antibiotics to begin immediately. Faster and more tailored treatment with this test could have huge implications for patient care.”

     

    The data were presented as a poster (#P1960) at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Madrid, Spain, 21-24th April, 2018. Whilst the data presented at ECCMID combined LiDia®’s core methodologies, prototype systems were on show at ECCMID, demonstrating the simple, rapid utility of the test, at the point-of-need.

     

    —Ends—

     

    About DNAe – www.dnae.com

    DNAe is developing its pioneering semiconductor DNA sequencing 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 LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

    DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. 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.

    A private company, with bases in London, UK and Carlsbad, CA, 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.

     

    Contact Details

     

    DNAe

    Dr Steve Allen, Chief Executive Officer, DNAe Group

    Tel: +44 (0)20 7036 2100

     

    Instinctif Partners (media relations)

    Tel: +44 (0)20 7457 2020

    Sue Charles / Ashley Tapp / Alex Bannister

    Email: DNAe@instinctif.com

     

     

     

     

     

     

  •  

    April 13, 2018 | DNAe to Present New Data and Preview its Blood-to-Result Test for Bloodstream Infection at ECCMID 2018

    DNAe to Present New Data and Preview its Blood-to-Result Test for Bloodstream Infection at ECCMID 2018

     

    London, UK and Carlsbad, CA, USA – 13 April 2018 DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections that can lead to sepsis, announces that new data will be presented on its LiDia® Bloodstream Infection (BSI) test1,2, at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Madrid, Spain, 21-24th April, 2018.

     

    A demonstration of the blood-to-result workflow for LiDia® BSI will be previewed at DNAe’s booth at ECCMID.

     

    Dr Steve Allen, CEO of DNAe Group Holdings, commented: “ECCMID comes at a pivotal time in our journey to bring this vital rapid diagnostic test to market. We are pleased to present key data and look forward to reaching more of the infectious disease community at the event this year. The congress gives us an excellent opportunity to showcase the LiDia® BSI closed cartridge-based test for the first time to a wide clinical audience at our stand, and to demonstrate its potential to support faster and more informed treatment of sepsis.”

     

    Details of the poster presentation are as follows:

     

    Poster Presentation – #P1960

     

    Title: Rapid Detection of Clinically-Confirmed Bloodstream Pathogens in Culture-Negative Specimens

    Time and Date: 12:30 pm - 1:30 pm CEST, Tuesday, 24th April

    Session: Diagnostic Approaches in Bacterial Bloodstream Infection

    Location: Paper Poster Arena

     

    The abstract is available online, here.

     

    DNAe’s Dr Steve Allen, Nick McCooke, Dr Nour Shublaq, Dr Nicola Casali and Alexandra Barr will be available to discuss the data. To arrange a meeting, email contact@dnae.com.

     

    LiDia® BSI Demonstrations

     

    Demonstrations will take place at DNAe’s booth between the following times:

     

    12:00 noon – 6 pm CEST, Saturday, 21st April

    9.30 am – 5 pm CEST, Sunday, 22nd April

    9.30 am – 5 pm CEST, Monday, 23rd April

    9.30 am – 2 pm CEST, Tuesday, 24th April

     

    Location: Booth #104

     

    If you would like to reserve a demonstration timeslot please RSVP in advance online, here.

     

    Operating as a closed cartridge-based test, LiDia® BSI utilizes highly sensitive sample preparation and semiconductor-based PCR analysis to rapidly identify pathogens and key antibiotic resistance markers. Aiming to deliver clinically actionable results straight from raw blood specimens in under 3 hours, LiDia® BSI will aid patient management by offering a significant reduction in time-to-result compared to the current standard of culture-based diagnosis, which generally requires several days to produce a result.

     

    —Ends—

     

    About DNAewww.dnae.com

    DNAe is developing its pioneering semiconductor DNA sequencing 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 LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

     

    DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. 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.

     

    A private company, with bases in London, UK and Carlsbad, CA, 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.

     

    Contact Details

     

    DNAe

    Dr Steve Allen, Chief Executive Officer, DNAe Group

    Tel: +44 (0)20 7036 2100

     

    Instinctif Partners (media relations)

    Tel: +44 (0)20 7457 2020

    Sue Charles / Ashley Tapp / Alex Bannister

    Email: DNAe@instinctif.com

     

    1Test in development. For Research Use Only. Not for use in diagnostic procedures

    2This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.

     

     

     

     

     

     

COMPANY DETAILS

 

Email: contact@dnae.com

Switchboard: +44 (0)20 7036 2100

Fax: +44 (0)20 7036 2144

Twitter: @dna_electronics

OFFICE  LOCATIONS

DNAe Group Holdings Ltd

Ugli Campus Block C

56 Wood Lane

London

W12 7SB

United Kingdom

 

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Carlsbad, CA 92008

USA

+1 (760) 444-9410

 

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