Diagnostics for the Real World’s multiplex respiratory virus rapid point-of-care tests approved for sale in New Zealand

24 September 2023

COVID-19, FluA/B and RSV in hospital, laboratory and non-laboratory settings

Cambridge, United Kingdom, October 4th 2022 – Diagnostics for the Real World Ltd (DRW), innovator of the SAMBA platform for rapid point-of-care detection of infectious diseases, today announces that it has received formal authorisation from the New Zealand government for the sale and distribution of its highly accurate molecular SAMBA II SARS-CoV-2 test, plus its new SAMBA II SARS-CoV-2/FluA/FluB and SAMBA II SARS-CoV-2/RSV multiplex tests – delivering transformative, rapid respiratory infection control capabilities to the country’s healthcare providers. DRW is now inviting expressions of interest from experienced medical technology distributors and potential sales partners to support its roll-out to this key market, which is expected to see a significant rise in demand for molecular point-of-care testing solutions following the full re-opening of New Zealand’s borders.

The official authorisation – underwritten by New Zealand’s Director-General of Health Dr Ashley Bloomfield and published in July 2022 – approves the immediate import, supply, sale, distribution and use by authorised persons of the SAMBA molecular point-of-care respiratory virus tests, including by District Health Boards and IANZ ISO 15189 accredited laboratories.

DRW’s new multiplex respiratory virus tests enable clinical teams to accurately detect and rapidly differentiate between coronavirus SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV), which can all present with very similar symptoms. With flu season in the country already underway, the new combined tests – one sample, one test, for multiple targets – provide a true point-of-care solution for New Zealand healthcare providers to boost infection control in hospitals and rest homes, optimise patient triaging, and speed access to urgent care services, including emergency surgery.

The SAMBA II nucleic acid-based amplification tests offer the highest levels of sensitivity and specificity and deliver results in under an hour from nose and throat swab samples run on the SAMBA II platform – DRW’s simple to use, fully automated ‘sample in, result out’ diagnostic system. SAMBA II has been used extensively within UK National Health Service hospitals since April 2020, becoming one of the main point-of-care devices for rapid COVID testing. The device is used in over 80 per cent of all major emergency departments in England to speed up admissions and improve access to urgent treatments. With symptomatic testing now at the forefront of diagnostic testing, hospitals are adopting the SAMBA II multiplex tests to differentiate between SARS-CoV-2, FluA, FluB and RSV, enabling further optimisation of patient management and infection control.

A study by University of Cambridge researchers published in Cell Reports Medicine in June 2020 reported that use of SAMBA devices for COVID-19 detection on hospital wards reduced the time that patients spent in COVID ‘holding wards’ by almost half.1

Dr Gabriel Hawthorne, Clinical Fellow at Cambridge University Hospitals, commented: “Working at the peak of the pandemic in the UK, I have seen first-hand the impact SAMBA has had on patient care inside Cambridge University Hospitals. Having a fast and reliable diagnostic tool accelerated the workflow inside the emergency department, helped placing patients appropriately across the wards, prevented cross-infections and ultimately enabled us to deliver timely interventions to those who needed it the most. It helped us across a large spectrum, from urgent surgeries to discharges to care homes. SAMBA was instrumental to keep our services running and saved costs on things like antibiotics and centralised laboratory tests”.

Commenting on the New Zealand authorisation, Diagnostics for the Real World Board Member Guido Guidetti added: “Our SAMBA II SARS-CoV-2 test has delivered transformative benefits across the UK’s National Health Service throughout the pandemic, earning its position as one of the NHS’s primary point-of-care, non-lab-based COVID-19 testing solutions. This use authorisation from the New Zealand government now enables us to bring vital multiplex diagnostic capabilities to the country’s healthcare providers. We actively welcome approaches from strong, committed sales partners who are excited by the opportunity to develop DRW’s customer base in New Zealand, Australia & the Pacific Islands.”

The robust, easy-to-use SAMBA II system – which can be operated with minimal training – offers a complete end-to-end process, delivering results within an hour and reducing the typical 1-2 day wait from centralised laboratory tests. The SAMBA II system delivers a true point-of-care system for in or out-of-lab use, from sample extraction, through to isothermal nucleic acid amplification, patented lateral flow detection and interpretation of results. SAMBA tests are a heat stable solution – with no requirement for cold chain transport or storage – and the sample collection buffer immediately inactivates the virus making it bench-safe for the user. As part of DRW’s commitment to maximising biosafety and minimising environmental impact, SAMBA’s patented extraction chemistry does not use guanidine for extraction (unlike most molecular assays), avoiding the risk of cyanide being produced as a by-product – a known risk in other PCR processes, requiring industrial disposal.

Notes to editors

Published paper: Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study (Cell Reports Medicine

Volume 1, Issue 5, 25 August 2020)

About Diagnostics for the Real World Ltd (DRW)

Diagnostics for the Real World Ltd (DRW) is the innovator of the Simple AMplification-Based Assay (SAMBA) platform for rapid point-of-care detection of infectious diseases – the simplest and most robust molecular diagnostic systems available today. DRW’s vision began in serving the large, unmet need for near-patient diagnostics in resource-limited regions of the world, pioneering innovative, high-performance, easy to use solutions that work in “real world” settings and supporting clinical services for people in real need. Today, DRW’s mission has expanded to meeting growing healthcare needs across the globe, delivering the advantages of decentralised point of care testing and treatment monitoring whenever and wherever they are needed most.

DRW’s focus is on the accurate and rapid testing of patient samples at, or near, the point of care, avoiding both the unreliability of previous simple point-of-care technologies, and the prohibitive costs and logistical difficulties associated with central laboratory testing. DRW’s high-performance SAMBA systems are providing a fast, accurate and cost-effective method for testing and diagnosis, and an accessible platform for transforming healthcare and health outcomes.

PRESS CONTACT for Diagnostics for the Real World (DRW):
Nicky Denovan
EvokedSet PR
Email: nicky[at]evokedset[dot]com
Phone: +44 (0) 118 328 2782

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