DNAe provides Business Update at start of 2024

• 2023 has been a transformative year as LiDia-SEQ™ devices proven with key data

• Expanded team with senior hires to support path towards commercialization

• Rishi Joshi joins as VP Product Management and Business Development

London, UK and Carlsbad, CA, USA – 05 January 2024 – DNAe, the next generation sequencing company developing novel diagnostics for use at the point-of-need, provides a business update on its LiDia-SEQ™ technology platform, and operational activities as the Company accelerates preparation of its commercialization strategy and roadmap.

Unique platform

DNAe has been developing a direct-from-sample, diagnostic sequencing platform that is user-friendly and suitable for operation at the point of need (including in community hospitals, STAT labs, and clinics), to provide comprehensive actionable information to clinicians in a matter of hours, versus days.  The company is actively developing a pipeline of tests in infectious disease, oncology and beyond. DNAe’s first diagnostic test will be an unprecedented test for sepsis / bloodstream infections (BSI) and antimicrobial resistance (AMR), which is unique in providing comprehensive and actionable clinical results directly from whole blood specimens in a few hours.

Sepsis/BSI diagnostic – unique achievements in 2023

In 2023, DNAe’s latest desktop devices generated key data, demonstrating their performance in sequencing pathogens directly from whole blood samples – all in a single prototype device, in a fully-automated manner and rapid timeframe.

The development program is on track with the Company achieving pivotal key milestones in 2023, with continued support in part from the company’s ongoing contract with BARDA*. The data gathered demonstrates its potential as a game-changer in the BSI and sepsis field, as the first truly sample-to-result sequencing platform in the world, and the first solution to deliver the combination of a comprehensive clinically-actionable report directly from whole blood in a few hours.  These data are now being shared with parties under confidentiality.

Oncology program

Also in the development pipeline, DNAe is applying its platform to cancer monitoring.  By detecting and sequencing tumor DNA, minimally-invasively, in a matter of hours, DNAe’s platform has the potential to expose unresponsive or recurrent cancer earlier. The Company collaborates with leading clinicians and researchers in the field, and this collaboration was awarded a UK Knowledge Transfer Partnership (KTP) by Innovate UK  in 2021. The collaboration is on track and now approaching completion. The program has generated key data from clinical samples and contrived samples, which are being shared with parties under confidentiality for the present.

Samuel Reed, CEO of DNAe, said: “2023 has been a strong year at DNAe. We have made tremendous leaps on our core mission and crossed a key threshold with our LiDia-SEQ™ platform as we approach the latter stages of development and plan commercialization for our sample to sequence technology. DNAe’s direct-from-specimen sequencing technology is unique in providing clinicians comprehensive, clinically-required reports in the required timeframe and environments. Delays in diagnosis result not only in lives lost and increased cost of care, but also in poor outcomes for survivors, sometimes even disability. With each milestone reached, we move closer to realizing our vision of improving patient outcomes worldwide.”

Operational progress

To further strengthen its capabilities and expertise, DNAe has expanded its team with the addition of over 40 talented individuals adding to the R&D, engineering, software and commercial teams across both London and Carlsbad facilities.

DNAe also announces the appointment of Rishi Joshi to the role of VP Product Management and Business Development, joining the Senior Management Team. Rishi has a strong track record in commercialization, product management, business development and marketing, with prior experience at Illumina, CooperSurgical, Invitae, and DNA Script. Rishi joins at a key point for DNAe’s commercialization agenda.

Samuel Reed added: “We have also taken the necessary steps to bolster our teams and infrastructure for the next stage of development, hiring across all functions at our London and Carlsbad operations. We are delighted to announce the appointment of Rishi Joshi as the new VP Product Management and Business Development. His extensive experience and proven track record will support our ambition / efforts to develop, launch, and commercialize our LiDia-SEQ™ technology platform.

“As we embark on the year ahead, we look forward to building on the progress made in 2023, setting our goals on the final transformative stage of development and start of commercialization.”

Conference attendance

Throughout the year, DNAe representatives attended the following scientific, partnering and investor conferences: Association for Molecular Pathology (AMP) 2023, the BARDA/Chan Zuckerburg Biohub mNGS Symposium, Medtech Strategist Innovation Summit, Anglonordic 2023, 6th ACTC, BARDA Industry Day, inaugural Jawdrop Summit, and Genesis 2023.

Upcoming meetings

Samuel Reed, CEO, and members of the DNAe team will be attending events around the 42nd JP Morgan Healthcare Conference, San Francisco from 8-11 January 2024. Please get in touch if you would like to arrange a meeting.  

– ENDS –

Contact details

DNAe

Samuel Reed, CEO, DNAe Group

Supriya Mathur, Global Head of Communications                                                      

Tel: +44 (0) 20 7036 2100 Email: supriya.mathur@dnae.com

About DNAe

DNAe is commercializing its pioneering semiconductor sequencing technology for healthcare applications where rapid point-of-need diagnostics are of critical need, including infectious disease and cancer testing and monitoring. It is developing the LiDia-SEQ™ system, a user-friendly, direct-from-specimen platform that performs genomic analysis on a microchip, to provide comprehensive, actionable information to clinicians in a matter of hours, versus days. DNAe’s initial focus is on infectious disease diagnostics, starting with a groundbreaking test for bloodstream infections (BSI) and antimicrobial resistance (AMR), which uses whole blood specimens to directly detect and identify infections that lead to sepsis. This will provide clinicians with actionable information to help select the appropriate antibiotics to treat the disease. A pipeline of follow-on tests is in development for viruses and cancer testing and monitoring.

DNAe has received “Breakthrough Device” designation from the US Food and Drug Administration (FDA) for its pioneering platform and first assay.

A private company, DNAe has operations in London, UK and Carlsbad, CA, USA. DNAe has received funding from The Biomedical Advanced Research and Development Authority (BARDA)* to develop its diagnostic platform, initially for antimicrobial-resistant infections. DNAe’s major shareholder is Genting Berhad, a Malaysian-based global investor with a growing portfolio of investments in cutting-edge life sciences companies.  www.dnae.com Follow us on LinkedIn, Twitter, Instagram

* 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.

About sepsis

Sepsis, which was often called “blood poisoning”, is the body’s overwhelming and life-threatening response to infection which can lead to tissue damage, organ failure, and death. Despite the best antibiotics and intensive care, sepsis is the primary cause of death from infection. Every three seconds, someone in the world dies of sepsis; globally sepsis claims 11 million lives a year1,2 . Sepsis cases are increasing, up by between 8% and 13%1 over the last decade, claiming more lives than bowel and breast cancer combined . Organizations like The UK Sepsis Trust (UKST) and Sepsis Alliance work tirelessly to fight this life-threatening condition, stop preventable deaths and support those affected by sepsis.

  1. https://www.healthdata.org/research-analysis/library/global-regional-and-national-sepsis-incidence-and-mortality-1990-2017
  2. Rhee C, Jones TM, Hamad Y, et al. Prevalence, Underlying Causes, and Preventability of Sepsis-Associated Mortality in US Acute Care Hospitals. JAMA Netw Open. 2019;2(2):e187571. doi:10.1001/jamanetworkopen.2018.7571
  3. https://www.cancerresearchuk.org/health-professional/cancer-statistics-for-the-uk