NEW YORK – The SARS-CoV-2 pandemic has resulted in many startups switching gears from their original disease focuses to tests for the virus, and the continued spike in the US likely means that trend will continue.
Startup Detect, formerly known as Homodeus and founded by life sciences veteran Jonathan Rothberg, was previously focused on building a platform to modify molecules found in nature to improve things like gene editing. Detect is part of 4Catalyzer, Rothberg's biotech incubator, and was funded by Rothberg in an early seed financing round. Once the firm achieved proof of concept for the platform, though, Detect was able to attract "tens of millions" of dollars from life science investors, including Foresight Capital, Cofounder Owen Kaye-Kauderer said.
It probably didn't hurt, either, that Rothberg was on board. As well as being the creator of the Ion Torrent next-generation sequencing platform now marketed by Thermo Fisher Scientific, he also was involved in the development of the 454 sequencing technology that was bought by Roche in 2007 and founded RainDance Technologies which developed droplet-based PCR platforms. RainDance was acquired by Bio-Rad Laboratories in 2017.
While developing Detect's platform, the coronavirus pandemic hit, and the company saw the "massive need for testing." It decided to use its expertise and resources to create diagnostic platform for COVID-19, Kaye-Kauderer said.
The test, called the Detect COVID-19 test, uses loop-mediated amplification technology, an alternative to PCR that operates at ambient temperatures, to detect SARS-CoV-2 RNA. The idea for the test was to take the accuracy of gold-standard PCR testing and combine it with "the cost, speed, and scale advantages of antigen tests," Kaye-Kauderer said. The significant demand for accurate point-of-care testing drove the company to create its first product for use at locations such as schools and workplaces. "You have to make the test inexpensive, portable or [with] a very small footprint, really easy to use," he said.
The test is in the final stages of clinical studies and has not yet been submitted to the US Food and Drug Administration for Emergency Use Authorization, but the company said it is "very, very close to submitting," with intentions to submit the application for symptomatic and asymptomatic testing. Kaye-Kauderer added that the company has been in constant contact with the agency since March and will launch the test with a capacity "in the hundreds of thousands" if and when EUA is received, with plans scale up to "millions" of tests over time.
The second product, however, was the real inspiration for the company: a home test. "The most distributed, decentralized, efficient, scalable way to get testing out there and control this virus is to get testing into the home, into the hands of laypeople," Kaye-Kauderer said. Detect has been working in parallel on a home test that would be sold over the counter and would test both symptomatic and asymptomatic people, returning results in under an hour, he added. The company is far along in finalizing the design for the at-home test and is focusing on making it more user friendly. It added that the first builds, which will be used for additional validation and study, will come off the manufacturing lines very soon.
Kaye-Kauderer said the firm is preparing clinical and usability studies for the home test for the first quarter of 2021 and hopes to launch the test at the end of Q1. Authorization for the home test is "a superset of the requirements for point-of-care authorization," he added, requiring not only the performance of a POC test, but also making sure it's easy enough for people to use without significant training. Only a few tests have received EUA for at-home coronavirus testing, including those from Lucira Health and Abbott.
The POC test will be launching with an extensive set of materials, including training and onboarding guidance with the kits and an interactive web-based guide to help untrained users perform the test, Kaye-Kauderer emphasized. There will also be extensive customer support to ensure users can collect specimens and perform the test accurately, which has been a common concern for diagnostic companies launching self-performed tests. "There's not great education about … what it means to have a false positive or a false negative and why these numbers matter," he said. "We're hoping to be really clear about how we communicate the benefits of our test so that it's clear what value we bring to the table."
Detect also attempted to bypass some of the supply chain challenges that have plagued other diagnostic companies by creating its own swabs to go with the test and providing everything necessary to complete the test, Kaye-Kaudurer said.
Kaye-Kauderer described the Detect COVID-19 test as using a razor-razorblade model, where there is a reusable base unit and a one-time disposable test. There will be two versions of the unit, one that can process one sample at a time, suitable for the home and certain POC environments, and one that can process 10 samples at a time, for settings like schools and nursing homes. The test requires between five and 10 minutes of hands-on time and then 55 minutes processing in the base unit.
The speed of the results will likely be a major source of interest for prospective users. Colleen Wall, a registered nurse who participated in the company's usability study, said the fastest results she received from SARS-CoV-2 tests performed by labs were ready in 12 hours. She added that she didn't find any difficulties with Detect's POC test and said it was "a quick and easy test" that could be used for screening, surveillance, and frequent testing.
The test "reads out like a pregnancy test on a lateral flow strip," Kaye-Kauderer said, with three lines on the reader. Three lines means the test is positive, two lines means the test is negative, and one means the test is invalid. The test has a control for an undisclosed gene that is present in all noses, so if that gene isn't detected, the test will mark it as invalid and have the user provide a new interior nasal sample, rather than providing a false negative or inaccurate result. The machine is running two reactions in parallel, one for SARS-CoV-2 and one for the control gene, which was tricky for the company to figure out at first, Kaye-Kauderer said.
It will also be priced at less than $50, "closer to the $35 mark," with the price decreasing over time, Kaye-Kauderer said. The lower cost is partially intended to get the test into the hands of people with fewer resources and provide testing for low-and-middle-income countries, which is "a huge part of our mission," he continued. The test will be launched in the US first, then will be expanded to other countries, namely LMICs. The company has been in talks with the Gates Foundation as an advisor for distributing the tests globally, although there is no formal agreement yet.
The firm currently doesn't have any published data, although Kaye-Kauderer said he is "confident that this 'PCR-like' moniker is appropriate for the level of accuracy that we're seeing." He added that it is comparable to other POC molecular tests that have received EUA and that it is "near or at PCR accuracy." Early detection of the virus is a key emphasis, since the viral load likely peaks before symptoms occur, and Kaye-Kauderer said the accuracy of the Detect test expands the window for detection.
Compared to other, more established companies with POC tests, such as Abbott, Quidel, and Roche, Detect is coming into the market late. But Kaye-Kauderer said the lateness was a result of the fact that the company "for all intents and purposes" started from scratch in March when the pandemic began and made sure to "not take any shortcuts" during the development and regulatory processes of the test. "We feel like we've moved as quickly as we can … we feel a lot of urgency," he said. "Experts think that this pandemic is not just going to be open-and-shut in the next three months; it will take a long time for herd immunity based on mass vaccination … and so, we think there will be a big role for us over the next six months to 12 months and beyond."
COVID-19 is only the beginning for the company and the Detect, he noted. The firm is looking at many other infectious diseases and is developing assays for influenza, streptococcal virus, and sexually transmitted diseases, all of which are in early development stages, Kaye-Kauderer said. POC testing like the Detect COVID-19 test will be important for future pandemic readiness and has future wellness implications, he added.
Part of the importance of this test, Kaye-Kauderer said, is due to the early missteps with testing in the US, the effects of which are still being felt. "It was very slow for the public to be made to understand how big of an impact testing can have … and so there wasn't enough of an emphasis on the role of testing," he said. In addition, the diagnostics industry as a whole wasn't prepared for the demand. "Many groups had to build these supply chains from scratch, start developing these tests from scratch or from little," he added.
Beyond the plans for the POC and home tests, Detect is also looking to provide multiplex testing in the future for SARS-CoV-2 and other respiratory infections. It also intends to branch out to susceptibility testing to determine preventatively which people may be more susceptible to certain viruses, Kaye-Kauderer said.
"We feel like we can be a disruptive element in the world that's dominated by these older diagnostic behemoths," he said.