Engineering 101

Point-of-Care Companies Racing To Provide COVID-19 Tests

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“The past few months have seen a new biological threat, the COVID-19 infection, also called new coronavirus, and caused by the SARS-CoV-2 virus, which has reshaped the entire diagnostics ecosystem,” said Sébastien Clerc, Technology & Market Analyst, Microfluidics, Sensing & Actuating at Yole Développement (Yole).

“As the epidemic has slowed down in China, it is Europe’s and the USA’s turn to be suffering. As a direct consequence, there is a strong demand for diagnostics tests to rapidly identify infected people and numerous companies started developing such tests, including companies relying on microfluidic technologies. In a few weeks, tens of tests were ready.”

The opportunity looks huge for diagnostics companies, but is the supply chain ready for mass-production of these tests in addition to their usual business or will it impact the production of other types of tests?

The pandemic poses interesting questions regarding the length of development, approval and manufacturing of tests when we have no time to waste but that reliability cannot be compromised. It will be imperative to analyze how these issues will be addressed once the pandemic will be behind us.

In this context, the market research & strategy consulting company Yole, intensively analyses the Point-of-Need market and technologies and offers a comprehensive understanding of the industry in the Point-of-Need Testing: Application of Microfluidic Technologies 2020 report. Aiming to provide an overview of what microfluidic technology offers to Point-of-Need testing, this report includes new major trends and evolution, market and revenue forecasts, and supply chain description and analysis.

For the first time in this report, Yole proposes accurate market data and forecasts for 2018 to 2025 per type of test spanning clinical chemistry, immunoassays, molecular diagnostics, cytometry, and more. In the report, market data and forecasts are also split per market segment, spanning emergency testing, remote area testing, doctor’s office and pharmacies, veterinary, agro-food, industrial, and more.

Though most non-human testing areas are lagging behind, veterinary testing sees plenty of tests now reaching commercialization. In addition, for the first time Yole provides detailed data on about 50 Point-of-Need companies, presented through charts and analyzes their strategies. Data includes the installed base of instruments, number of instruments placed per year, and number of tests per instrument per year. It also provides ASP per type of test, and consumable pull through per instrument.

Everything that has to deal with human health has to face very slow regulatory processes, which are not adapted in the current emergency context. In front of the sanitary emergency, the FDA and other regulatory bodies finally lowered their standards, granting ‘Emergency Use Authorizations’ for some of these tests.

Since mid-march, companies like Cepheid, GenMark, BioFire/bioMérieux, and Mesa Biotech got approval for microfluidic-based rapid molecular testing for SARS-CoV-2. Even more companies have released such tests for RUO , waiting for approval. The mid-term goal for some of these companies will be to add SARS-CoV-2 to their syndromic respiratory panels. There is a race towards diminution of the time to result, from days to hours to minutes, but also towards increasing the throughput. Abbott announced a 13-minute test at the end of March, but its IDNOW platform deals with only one sample at the time. Other platforms take longer to deliver results but some of them can process multiple samples per run.

The COVID-19 pandemic highlights the need for rapid and actionable results at the point-of-care, which is true for various, increasingly complex and comprehensive test panels. To achieve that, molecular diagnostics are key. This category of test is now making it to the next step, thanks to ever more complex integration and automation on-chip.

According to Sébastien Clerc: “Molecular diagnostic tests represented more than half of the market value in 2019 and will represent about 70% by 2025. The overall microfluidic-based Point-of-Need testing market will grow from $4.1 billion in 2019 to $10.1 billion in 2025, driven by human diagnostics segments.”

Companies are racing towards ever-higher-plex panels, meaning they want to enable detection of ever more pathogens in a single test. They also aim to reduce time-to-result below 20 minutes to enable use of their technologies at the point-of-care, for example during classic medical appointments. Both are difficult to achieve at the same time, therefore companies have to make some choices.

However, some companies are on track to deliver the promise of high-plex, rapid molecular diagnostics at the point-of-care in the coming years and are introduced in the report.

The holy grail of diagnostics would be a small box able to perform any kind of test in minutes. Platforms that combine clinical chemistry and immunoassays have existed for a long time, but now some companies are addressing a much bigger challenge: combining clinical chemistry, immunoassays, cytometry and molecular diagnostics with the same instrument, at the point-of-care.

By doing so, in theory a diagnostics facility could purchase only one instrument and run hundreds of different tests on that platform instead of having to purchase many different instruments, which is costly and requires lab space, and train personnel to use all these instruments.

“Today’s difficulty is to be able to integrate all these different detection methods in a single, low-footprint and affordable instrument, while being able to design a cost-effective microfluidic cartridge able to run various types of tests on the same footprint,” added Sébastien Clerc. “It is difficult to say who will succeed in that area. First-comers include companies like Bosch Healthcare with the Vivalytic platform, Qorvo Biotechnologies, Fluxergy and Truvian Sciences.”

Such multi-modal platforms are extremely promising, comments Yole’s team in this new Point-of-Need report. But they require a much heavier R&D effort than usual point-of-care platforms, which are already difficult to bring to the market and to scale-up in a cost effective manner.

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