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Ubiquitome Pushes Compact PCR System for Decentralized Coronavirus Testing

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SAN FRANCISCO – As of Monday, the worldwide death toll attributed to COVID-19, the illness caused by SARS-CoV-2, had topped 3,000, and the total number of cases had risen to nearly 90,000 in 65 countries, according to the World Health Organization. Six people have died in the US.

The US Food and Drug Administration has authorized high-complexity CLIA-certified labs to immediately perform tests they've developed and validated for the virus while they are pursuing emergency use authorization. In addition, two public health labs in New York state have been granted EUA to run an assay to detect SARS-CoV-2 on nasopharyngeal and oropharyngeal swabs and sputum samples collected from people who meet the clinical or epidemiological criteria.

However, as COVID-19 continues to evolve into a pandemic, there remains a need for rapid, decentralized testing. At the Molecular Medicine Tri-Conference here on Monday, Ubiquitome CEO Paul Pickering offered his company's solution: a quick, mobile, open real-time PCR device called Liberty16, based on the same technology found in gold-standard real-time PCR benchtop instruments, but handheld and battery-powered.

Ubiquitome launched Liberty16 in October 2018. When closed, the machine is 21.2 cm long by 11 cm wide by 11.5 cm tall, and weighs about 2.5 kg. It runs on a light, small, and rechargeable lithium battery for two to three hours. At the time, Ubiquitome said the goal of the 16-well instrument was to personalize real-time PCR and make it more accessible to researchers. Pickering previously said that Liberty16 was designed for use in the field but was also being marketed as an affordable way to reduce backlog in research labs.

Ubiquitome had promised to make genomics ubiquitous by providing portable and low-cost qPCR solutions, and Liberty16 was "a big and bold step forward … around that promise," he said.

In his Tri-Con presentation, Pickering said Liberty16 is "dynamically deployable." Because the machine is small and light, rather than a static instrument that has to live on a benchtop, multiple units can be dispatched to the field in the event of an outbreak. It can also report results in real time, and the testing interface is operated through an iPhone or iPad app and connected through the cloud — ultimately, Pickering said, Ubiquitome could have the ability to deploy thousands of units to conduct thousands of tests in the field simultaneously.

Further, the system is able to read different sample types, he said. If the CDC finds that the optimal sample type for detection of SARS-CoV-2 is blood, Liberty16 would be able to test for the virus in blood. But it would also be capable of testing nasopharyngeal and oropharyngeal swabs and sputum samples, as the labs in New York plan to do.

Pickering said Ubiquitome recently collaborated with the Friedrich-Loeffler Institute, an animal testing lab in Germany, to develop a protocol for Liberty16 that was used to detect traces of the viral RNA of PPRV, a highly contagious disease that affects sheep and goats. That test took 40 minutes to run with the same sensitivity as Bio-Rad Technologies' CFX benchtop real-time PCR instrument, Pickering noted.

Liberty16 was also able to detect positive coronavirus control material at the same level as the Roche LightCycler 480 benchtop instrument, he also said. Liberty16 is not yet FDA-approved as a commercially available coronavirus testing system. In an interview, Pickering said the company is pursuing FDA emergency use authorization, and he believes that the work Ubiquitome did comparing Liberty16 to the Roche LightCycler 480 will work in the firm's favor.

The company hasn't yet tested patient samples on the Liberty16. The logistics of that can be tricky, Pickering said. However, Ubiquitome is hoping to test patient samples soon. In the meantime, the company has been using positive controls to test its system, using a test assay from Integrated DNA Technologies.

IDT on Tuesday was authorized by the FDA under the CDC's existing EUA to provide reagents for SARS-CoV-2 diagnostic testing.

If Ubiquitome does get FDA approval to sell the system for coronavirus testing, it would work well as a field instrument, to test people in airports or in any other locations where results would be needed quickly, Pickering said. It would take about 30 seconds to load the samples into the instrument and start a test run. And because the whole thing is controlled using an iPhone interface, the entire process is "super simple," he added.

For the time being, the company doesn't have a specific geographic deployment plan. That will depend on when it receives EUA from the FDA and what parts of the US or the world are most in need of a rapid testing system, Pickering said. But flexibility is one of Liberty16's strengths.

"There's no question that some companies believe that an integrated system is the way to go, but that's limiting," he said. "We suggest that the weakness of [an integrated workflow solution] is that if [a system] is not optimized for the sample type and the target, then it's going to give subpar results. If you keep that piece of the front end open toward innovation, to different approaches, to whatever's the best for a given situation, and that's what you plug in and what you offer as the complete solution, [you get] higher sensitivity and specificity."

Ultimately, he added, the real selling point of Liberty16 is that it takes a type of instrument that works very well for diagnostic purposes, but makes it smaller and usable in a wider range of locations at a tenth of the price.

"Still today in diagnostic laboratories, most of the tests … are run on open systems — they like open systems," Pickering said, noting that the Roche and Bio-Rad instruments, and the Thermo Fisher Scientific Applied Biosystems 7500 Fast Real-Time PCR platform probably handle three-quarters of the real-time PCR test volume that goes through laboratories. "Those are all open systems," he said. "All we're doing is taking that same technology and putting it in a format where you can deploy it wherever it's needed on a dynamic basis."