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FDA EUA in Hand, 3EO Health Prepares New Molecular Point-of-Care Device for Launch


NEW YORK – After receiving Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 test late last month, startup 3EO Health is preparing to launch the assay with its portable molecular device that can return results in 30 minutes.

Building on technology licensed from the Wyss Institute for Biologically Inspired Engineering at Harvard University and developed further by the firm, the company's portable molecular platform can qualitatively detect SARS-CoV-2 from nasal swabs. Like many other point-of-care molecular devices, 3EO's technology is based on loop-mediated isothermal amplification, but according to Thomas Schaus, the firm's head of research and scientific cofounder, its innovation is that it can generate an "enormous signal" as a reaction occurs. 

The device's mechanics are relatively simple, using straightforward plastics and consumable design to make it easy to manufacture. What differentiates it from other LAMP-based testing technologies is its biochemistry, Schaus said. While he declined to detail the company's technology, he said its proprietary methods limit the inhibition of a sample and allow a much larger signal to be generated. 

The company's swab also uses proprietary technology: a sleeve that includes a metering system to put an appropriate amount of a sample into the device. This ensures that there is enough sample to detect SARS-CoV-2 but prevents excess inhibition from too much of a sample being added, Schaus said. 

The swab is then inserted into a consumable key that is placed into the device where the modified amplification reaction occurs, and the fluorescent signal is released. The device monitors that signal with a microprocessor and utilizes an algorithm to determine whether the signal indicates a positive or negative result. 

3EO Health's SARS-CoV-2 test includes three separate viral targets and one control to ensure that all known and future foreseeable variants can be detected, Schaus said, adding all of the targets are combined into a single reaction, which allows the company to save money on reagents by only running one reaction.

While the SARS-CoV-2 test will be the first product on the market, Schaus noted that the company has other tests in development and has plans to build other devices that can run more than one sample at a time. The device will stay the same regardless of the test, and the only things that will change are the reagents and primers used for the assay. The firm also has plans to expand its sample types to saliva and urine, depending on what it is testing for. 

3EO CEO Jeremy Schubert said that SARS-CoV-2 has served as the "base case … to get the technology where we wanted it," but that it will expand to other diseases. The firm has two multiplex respiratory assays and a Streptococcus assay in development, with plans to move into the sexually transmitted infection space, as well. 

Although COVID-19 testing demand has declined significantly, Schubert said that physicians' offices are still using COVID-19 tests and have a demand for them, particularly as this year's respiratory season ramps up. Physicians' offices, urgent care centers, and pharmacies are the main consumer focus for the company's direct marketing efforts, he added. 3EO Health's strategy is to seek a "one-to-many relationship, where we can use one device to treat multiple patients," he said. The company's direct sales team also aims to work with school athletic departments and public health organizations to see how to optimize its platform for use in those settings. 

The company has inked deals with multiple undisclosed US-based diagnostic distributors to offer its test, Schubert noted. Through its distributors' networks, it expects the test to reach broader segments of the population, such as schools and nursing homes, he added.

It also hopes to partner with healthcare systems to generate outside data, as it currently only has internal data. The data it submitted to the FDA for EUA validated the test with 195 patient samples, detecting 95 percent of positive samples and 100 percent of negative samples compared with a standard laboratory PCR-based test. 

The firm plans on conducting a full clinical trial and submitting the test for full FDA 510(k) clearance sometime next year, Schubert said. It also expects to broaden the test menu by the end of 2024, although that timeline is dependent on funding and collaborations, he noted. Thus far, 3EO Health has raised more than $30 million, largely from venture capital and with some funding from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority. The company is also in the middle of a minor funding round to raise working capital to support the launch of the SARS-CoV-2 test in November, Schubert said, and will evaluate its next funding round once the test has launched. 

Throughout the COVID-19 pandemic, many other startups and companies attempted to crack the point-of-care molecular diagnostic market with portable nucleic acid amplification devices. Cue Health currently sells its Cue Reader and its COVID-19 test, although it has lately been mired in controversy as its stock price has plummeted and shareholders have publicly expressed concerns about its business plan. Lucira Health, meanwhile, offered its molecular single-use Check It COVID-19 test, as well as an at-home influenza and COVID-19 test, but the company went bankrupt and was acquired by Pfizer. 

Whether 3EO Health's device may be able to succeed where other companies have faltered remains to be seen. Schaus noted that it has a cost advantage because it is able to use fewer reagents and supplies. The reusable device will retail for about $110, with individual tests costing less than $20. In contrast, Cue Health's device costs $200 and a three-pack of COVID-19 tests is $165. Lucira's single-use tests cost as little as $30 but are no longer available, although according to the company's website the test will soon be available again. 

3EO Health's cost is the key differentiating factor, according to Schaus. The test is "easy to use … but we can put it together and sell it for a much lower price than the few other competitors that have made it to the finish line so far," he said. "That's, I think, our real value-add to the market."