Dive Brief:

• Thermo Fisher Scientific has introduced a device for capturing viral particles from the air for PCR analysis to determine if a pathogen is present in an indoor environment.

• The AerosolSense Sampler is aimed at hospitals and other institutions to determine if SARS-CoV-2 is getting into their facilities despite existing precautions. However, the need to run a PCR test on the captured particles means it could take a day or more to get results.

• The device comes to market as Thermo Fisher prepares its business for the next stage of the pandemic, in which vaccines may drive down cases but create a need for ways to mitigate the risk of reopening buildings.

Dive Insight:

Thermo Fisher played a major role in the initial response to COVID-19, generating $6.6 billion in sales related to the pandemic in 2020 across its diagnostic, personal protective equipment and biopharma R&D and manufacturing businesses. COVID-19-related sales are expected to grow this year, largely due to a doubling of vaccine revenues, but at some point the diagnostic tailwind looks set to fade.

Yet, while the need for PCR testing of symptomatic individuals may decline as vaccination rates rise, the reopening of economies could create opportunities for ways to stop the coronavirus entering and spreading through institutions. Thermo Fisher is moving to seize those opportunities, partnering with Color Health on school testing and introducing AerosolSense Sampler in quick succession.

Thermo Fisher is framing AerosolSense Sampler as a device that can help institutions reopen safely and stay open. The tabletop device pulls in air from the environment and runs it over a cartridge designed to capture viral particles. After waiting at least two hours, the user removes the cartridge and sends it to a lab for processing.

The wait for the results will depend on access to testing capabilities. Thermo Fisher has performed initial feasibility testing using the 30-minute PCR kit it acquired in its takeover of Mesa Biotech, the New York Times reports, but institutions will typically wait longer. A hospital with an on-site lab could get results in two hours, while a school that needs to use a third-party lab could wait two days. 

Whatever the turnaround time, the sampler is, to a greater or lesser extent, showing whether the virus was present in the past, rather than providing a real-time picture. Even so, a positive test may prove valuable if it reveals the coronavirus is entering the environment despite precautions such as screening tests and masking. Sites in that situation may need to reevaluate their actions.

A more fundamental concern is whether the device can consistently detect SARS-CoV-2. The virus may make up a tiny fraction of all the particles in a room, meaning false negatives could occur if the device is insufficiently sensitive. Thermo Fisher validated AerosolSense Sampler in collaboration with the University of Oregon Biology and the Built Environment Center, which this week published a preprint paper describing their bench and room-scale studies of the device.

In the room-scale studies, the device consistently detected the virus at 0.089 genome copies per liter of room air (gc/L) when air was sampled for eight hours or more. However, the virus needed to be present at 31.8 gc/L to consistently detect the pathogen when the sampling time was cut to 75 minutes. The preprint authors cited other research that found air concentrations of around 31.8 gc/L in SARS-CoV-2 healthcare environments.

Thermo Fisher is selling the device for $4,995. Each sale could also provide Thermo Fisher with an ongoing source of revenues as sites purchase additional cartridges and, potentially, make use of its testing services. Initially, the focus is on using the devices to detect SARS-CoV-2 but they could also be used to capture other in-air pathogens, positioning Thermo Fisher to continue selling cartridges if there is a post-pandemic demand for ways to stop the spread of other infectious diseases.