Dr Helen Lee was an invited speaker recently at a key All-Party Parliamentary Group for Life Sciences meeting at Portcullis House in Westminster (March 2022).
The meeting drew together MPs and life sciences trade associations to consider the future applications for innovative UK medicines and diagnostics developed in rapid response to the challenge of COVID-19 – including DRW’s SAMBA II SARS-CoV-2 test – and to explore how government policy can continue to facilitate and drive these major advances that are bolstering the UK's position as a global leader in lifesciences. Presenting organisations included AstraZeneca, Diagnostics for the Real World, and IBM Lifesciences.
The APPG for Life Sciences is chaired by Cambridge MP Daniel Zeichner, and supported by a secretariat comprised of the key industry trade associations – BioIndustry Association, The Association of the British Pharmaceutical Industry, and the British In Vitro Diagnostics Association (BIVDA).
Parliamentarians and industry body representatives heard from Dr Lee about the extraordinary development journey undertaken by DRW as it rapidly adapted and scaled up for volume manufacture its rapid molecular point-of-care COVID-19 test run on the breakthrough SAMBA platform. The fully automated, portable SAMBA system delivers a true point-of-care solution, from sample-in to results-out in a little over an hour – a transformative capability for clinicians during the COVID-19 public health crisis.
Dr Lee discussed the landmark deployment of SAMBA across over 100 NHS hospitals nationwide, and also highlighted the value it has delivered in out-of hospital settings, including schools, care homes and prisons. Over 2 million SAMBA tests have been shipped to NHS hospitals between Apr 2020 and Feb 2022, representing a remarkable achievement in product optimisation, production capacity scale-up, and delivery against KPI targets.
The impact of the SAMBA deployment within the NHS has been significant. With the ability to harness a true near-patient solution, diagnostic testing in hospitals has moved to the front of the patient pathway. A study found that use of the SAMBA test during the pandemic reduced the mean length of stay on COVID-19 ‘‘holding’’ wards from 58.5 hours to 29.9 hours (Collier et al., 2020). The reduced testing turnaround time enabled by the SAMBA technology has also increased the availability of isolation rooms, sped up discharge to care homes, and allows patients faster access to vital hospital procedures – including surgery, chemotherapy, transplantation and maternity services – while minimising disruption to service due to staff absence.
A key advantage of DRW’s solution is that, unlike PCR tests, the patented chemistry in the SAMBA system does not utilise guanidine, meaning that there is no production of hazardous cyanide as by-product of use. In addition to improving biosafety, this ensured that DRW did not have to compete for the same raw chemistry components within the pressured global supply chain during the height of the pandemic.
SAMBA is one of only three ‘Category 1’ COVID point-of-care tests used within NHS – requiring no confirmation of positive results by testing with another platform. SAMBA can detect two targets of all known Variants of Concern (VOC) and Variants Under Investigation (VUI) – all known variants – contributing to the global effort to detect and effectively respond to SARS-CoV-2 mutations. Through its commitment, tenacity and ingenuity, the DRW team succeeded in repurposing the SAMBA system for rapid COVID testing in only 8 weeks, from test design to final regulatory approval.
Dr Lee closed her session with her view on the steps required to maximise the UK’s preparedness for future pandemics. She highlighted the critical need for rapid initial virus identification in developing countries, plus the value of forming a diagnostic network in the UK that can work closely with the UK Health Security Agency to develop national capabilities for RNA production, expedite the supply of clinical samples for test evaluation, and to facilitate access to P3 or P4 safety facilities and the availability of clinical sites that can rapidly evaluate new diagnostics and support regulatory licencing. Finally, Dr Lee emphasised the need for increased accessible funding to enable organisations in the diagnostic value chain to react quickly together, for more resources to allow faster review of data for regulatory approval, and the crucial importance of continuing the momentum in developing infrastructure for decentralised POC testing – including community diagnostics centre to reduce requirement for testing at A&E and within urgent care settings.
The UK government recently published its strategy report, “COVID-19 Response – Living with COVID-19”, which includes details of the UK Health Security Agency’s aims in building resilience against future COVID-19 outbreaks and maximising preparedness for future pandemics. The full report can be found here.
Image copyright: DRW