The current molecular diagnostics landscape is fraught with challenges and an ever pressing threat of emerging High Consequence Infectious Diseases (HCIDs). The global inability and lack of preparedness in responding to these infectious diseases was highlighted during the COVID-19 pandemic. However this further clarified the following challenges facing molecular diagnostics and the lessons to be learnt:

Pandemic preparedness through proactive surveillance and monitoring is the key to identifying and containing emerging diseases before they have a chance to escalate into epidemics and ultimately pandemics. Most novel diseases likely circulate for some time in animals and humans before they’re eventually detected in clinical cases.

This crucial period of opportunity is the early stage when diseases need to be identified. For this to be achieved testing efforts have to be rapidly deployed and established early to focus on isolating the source of infection in-country at the point of origin wherever that may be. For too long, we have allowed a cycle of panic and neglect when it comes to pandemics: we ramp up efforts when there’s a serious threat, then quickly forget about them once the threat appears to subside. This reactive mindset needs to be replaced with a proactive one, to ensure we are one step ahead of the next emerging disease and fully prepared.

The early detection, quarantine and containment of emerging pathogens is integral to prevent infectious diseases from establishing and spreading globally. Current testing methods require patient samples to be collected and sent to a centralized laboratory which often carries a lead-time of several days. In this time whilst waiting for the results potentially infected patients are free to travel, transmit and spread the disease to others.

Early detection and containment is only possible with platforms that possess the necessary sensitivity and speed to accurately detect subclinical, asymptomatic or non-symptomatic cases whilst the patient waits. This capability is currently unfulfilled in molecular diagnostics and is a vulnerable chink in the armour of the worlds biodefence. Lateral Flow Testing (LFT) is commonly used to inexpensively screen populations on a large scale but severely lacks the sensitivity and accuracy to effectively deliver results. Patients are required to have an extremely high viral load for LFT devices to detect the target by which time they have already spread the disease throughout the population. Poor accuracy also results in a high frequency of both false negatives and positives. 

Currently the only option for deploying RT-qPCR diagnostics outside of centralized lab facilities is in the form of near patient testing platforms. However these platforms require accompanying field laboratories, specialist personnel and dedicated equipment. The platform itself does not represent true portability and relies instead on also moving the laboratory, personnel and equipment required so it can be operated in a semi-decentralized setting. This attempt of portability is not adequate and needs to be addressed by an effective platform which is truly portable and capable of being independently deployed anywhere in the world in any environment. 

Many current platform offerings use complex cartridge based consumables and require specialist personnel to operate them and process samples. This makes it prohibitively expensive for screening large numbers and makes testing inaccessible to the majority of populations, in particular Low and Middle Income Countries (LMICs) who already suffer from an array of Viral Haemorrhagic Fevers (VHFs) and is often where High Consequence Infectious Diseases (HCIDs) originate from.