Recent Outbreaks Underscore Urgency in Bringing Diagnostics to Market
Threats like bacteria, fungi, viruses, and toxins – especially those that are emerging and novel – pose a constant challenge. Effective biodetection of these threats is often a race against time because it can be difficult for potentially impacted people to access the right diagnostics when needed, so they may not be able to get the care necessary as symptoms arise and before illness. As the COVID-19 pandemic showed, there has been a general move from large scale clinical laboratories to more portable, smaller point-of-care In Vitro Diagnostic (IVD) devices, best exemplified by the at-home diagnostic tests so many used for at-home testing. Recent outbreaks of mpox and the Sudan Ebola Virus further reinforce this need.
In February 2023, FDA issued the last of more than 400 COVID-19 Emergency Use Authorizations (EUA), a demonstration of the surge of products developed to meet consumer needs at a critical time. It is expected that this trend will continue and be driven by technological developments in advanced robotics, microfabrication, microfluidics, nanotechnology, and advanced materials.
IVD devices encompass a broad range of tests that include infectious diseases and have been used to detect and diagnose pathogens for decades. Ideally, such point-of-care diagnostic devices are portable, effective in low- and high-resource environments, have easily interpreted results, and limited logistical or storage requirements from manufacturer-to-end user.
As the market for infectious disease IVDs continues to expand to address increases in global infectious disease outbreaks, scientific advancements like novel bioengineering and assay chemistry developments support their increasing functionality. A wide scope of factors including detection technology, market assessments, and regulatory considerations should also be considered in their development. As a result, a clearly defined path from conceptualization to market for IVDs is necessary.
In the 1980s, the advent of molecular biology based on the polymerase chain reaction (PCR) revolutionized molecular diagnostics by providing high sensitivity-specificity, faster results, and set the foundation for genomic sequencing. Real-time qPCR was developed in the late 1990s and is now considered the “gold standard” for molecular diagnostics, advancing quicker sample-result times and offering quantitative aspects. By the early 2000s, the Joint Biological Agent Identification and Diagnostic System (JBAIDS) platform, which was a rugged-fieldable instrument used by the U.S. military, became the first FDA approved platform for diagnostics of biological threats. This and other examples of qPCR resulting from the JBAIDS program of record continue to be important tools used for detecting current threat outbreaks.
Once a market need arises – like the emergence of a new biothreat or infectious disease threat – development roadmaps ideally begin with a Target Product Profile (TPP), which outlines the overall scope of an IVD’s development. The application and approach for biodetection depends on the type of sample taken – such as environmental, like air and soil, or clinical like blood, respiratory, or other bodily fluid; and when that sample is taken. Additional considerations should include assay targeting approach limitations, whether quantitative or qualitative result outputs will have the most meaningful impact to the target audience, and what level of complexity the usage environment will allow for. Following development and successful validation, devices can then be submitted for the appropriate regulatory approvals. As IVDs often go through an iterative process of gathering feedback and its incorporation during re-engineering/reformulation, the same general lifecycle is followed. As an example, the development steps of the most common COVID-19 IVDs are shown on the lifecycle below.
The growing number and increased likelihood of various biothreats and infectious disease outbreaks require the need for more rapid design of diagnostic assays and mass production of them. By improving upon the IVD development lifecycle and accelerating their path from conceptualization to market, we will enable significant changes in the future of diagnostics and their impact on the practices of laboratory medicine, public health, and healthcare delivery.
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Contact MRIGlobal to further understand our work with biothreats and infectious diseases. Through a multidisciplinary approach, we provide scientific and subject matter expertise for development of medical countermeasures research against specific threats, while expanding and accelerating the delivery of high quality clinical diagnostic products.
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