NEW YORK – As the COVID-19 pandemic continues and schools, workplaces, and other public places begin to reopen, rapid tests with quick turnaround times and low costs are becoming more important than ever.
To facilitate the development of rapid tests and accelerate the safe return to public spaces, nonprofit OpenCovidScreen started the $5 million Rapid COVID Testing XPrize competition and the separate $50 million COVID Apollo Project to connect investors with test developers. The team-based XPrize competition has had more than 450 teams sign up from 58 countries, with sign-ups open until Sept. 8. Teams include personnel from diagnostic companies, academic medical centers, and reference laboratories.
The goal of the competition is to promote a variety of solutions, said OpenCovidScreen's Science Lead Chris Mason. "This is one case where it's, you know, more is more, not less is more," he noted. "Due to the stress on supply chains, due to inaccessibility to a lot of common reagents, we need diversification of the solutions to testing, much like you would in a stock portfolio."
The XPrize competition is making space for these different technologies by allowing teams to submit in one of four categories: At Home, Point-of-Care, Distributed Lab, or High-Throughput Lab. The competition also encourages a variety of testing technologies, including PCR, CRISPR, antigen detection, next-generation sequencing, and isothermal/Loop Mediated Isothermal Amplification. One of the teams that has registered, HolographicDiagnostics, led by David Grier, a professor of physics at New York University, uses holographic video microscopy to detect viruses binding to surfaces of microscopic test beads.
Another competitor, Volta Labs, has a platform running a variety of diagnostics, such as Enzyme Linked Immunosorbent Assays and LAMP, that uses electric fields to "manipulate droplets on an open configuration chip," said a spokesperson for the company. In contrast to some of the other teams, Volta is still considering the best route to pursue the XPrize competition, which has allowed teams at a variety of development levels to join.
President and Co-Founder of OpenCovidScreen Jeff Huber emphasized the four main qualities the organization believes testing needs in order to keep up with the pandemic, namely that it is frequent, fast, cheap, and easy. Frequency should be at least weekly, to ensure schools and businesses can stay open and screening programs can "catch occurrences before they become outbreaks," he said. "Going back [to school or work] is easy," he added. "Staying open is hard. And we believe that testing is a critical component to make that work."
Fast turnaround times are essential as well. Although, "ideally you want a magical device that provides an instant result," Huber continued, "we've relaxed the constraint a little bit for these kinds of programs to provide what we call the 'next morning' result." The test should be quick enough to, for example, stop an employee from going into work the next day and being a "super spreader," he said. Huber did note that they didn't want to sacrifice quality for speed, however.
Bottlenecks in laboratory testing have been a major issue throughout the US response to the COVID-19 pandemic, said Jon Stenstrom, CEO of Sealed Bio, one of the participants in the competition. "A test is less useful if results take days to get back," he said. "We've had countless conversations with people who wait in long lines, suffer through invasive nasal swabs, only to wait unnervingly for days to see if they're infected."
Price is another major factor in improving the current testing landscape, with current tests retailing between $100 and $150, which Huber and the team believe is too expensive. "When you do the bottom-up cost of the chemistry, you should be able to deliver a quality result on the order of five dollars," Huber said. OpenCovidScreen has been describing it as "less than the price of a latte," he continued, because "if we can get it to that price, we can get it where it's self-fundable."
Parker Cassidy, a partner at RA Capital, one of the investment firms that contributed to launching the competition and is leading the COVID Apollo Project, said that with the price points currently around $150 per test, we "can't afford at scale to broadly reopen the economy."
Ease of use is the final piece of the puzzle, whether through saliva-based approaches or less invasive nasal swabs that can be self-collected or require minimal training.
The XPrize competition has a variety of big-name sponsors, including payors like Anthem and Blue Cross/Blue Shield; diagnostic and tools companies like Illumina, Thermo Fisher Scientific, Exact Sciences, and Twist Biosciences; and tech giants like Google and Amazon. Weill-Cornell Medicine and HudsonAlpha Institute for Biotechnology are the primary laboratory and validation partners.
Early in the development of the competition, OpenCovidScreen was working with the state of California's COVID-19 testing task force on expanding testing, leading Governor Gavin Newsom to endorse the competition when it launched at the end of July.
Twenty finalist teams will be announced Oct. 6, with clinical validation and judging occurring throughout October and November. The competition will have five winners, who will each receive $1 million, half when the pilot teams are announced in December and half after the completion of successful pilot rounds in February 2021. Entries will be judged based on overall innovation of the product, performance, turnaround time, scaling properties, ease of use, and cost.
Beyond the cash prize, winners also will be connected to a wide network of investors, including RA Capital, Bain Capital, Perceptive Advisors, Samsara Biocapital, and the Redmile Group. Those investors are leading the related, but separate, $50 million COVID Apollo Project, which will work with the teams to accelerate the best technologies to market, regardless of the winning teams.
Cassidy said the Apollo Project partners can act as "ready-made syndicates" to help companies accelerate the development and scale of their tests. "The goal is to be a magnet for the best ideas," he continued. Cassidy emphasized that the tests must be commercially viable and that the firms plan to invest "in a standard way."
Both the competition and Apollo Project are intended to promote collaboration between the teams as well, said Matthew MacKay, a graduate student at Weill Cornell Medical College who worked with Mason on a paper published in Nature Biotechnology that provided standardized diagnostic test information from Emergency Use Authorization submissions to the US Food and Drug Administration and also promoted the competition. There's a large amount of collaboration possible throughout the competition and it can serve as an "open research community," he said. Teams located in different countries can virtually collaborate, and if certain teams have solutions that would work well together or can be combined, the competition leaders can facilitate those collaborations, MacKay said.
MacKay and Mason, along with a life sciences ventures investor Nick Haft earlier this year also cofounded Resilience Health, which is curating a comparison of EUA molecular tests to provide to consulting services, but also is offering this evidence base for the public good, freely offering its test analyses on its website. This public benefit corporation is not affiliated with the OpenCovidScreen organization or the X Prize competition.
Each team is at a different stage of development and has different needs from investors. For CEO and Co-Founder of LessTests Ruth Polachek, whose single-step pooling solution using plug-in software is accredited by Israel's Ministry of Health, further development plans include a stronger algorithm with additional features like artificial intelligence for test prediction.
Meanwhile, Kaya17 Founder and CEO Sulatha Dwarakanath said the firm's 7-minute on-the-spot test would be submitted to the FDA for EUA next month. Another participant, ChromaCode, launched its high-definition PCR test and received EUA two months ago, according to Chris Macdonald, the firm's VP of operations and data science.
Many of the technologies being used in the competition aren't specific to COVID-19, competitors noted. Although this competition is focused specifically on COVID-19 solutions, MacKay noted that similar competitions or collaborative efforts could be initiated for other diseases, such as cancer.
Despite being a competition, Huber noted that the ultimate goal is to encourage as many testing solutions as possible to reduce the spread of COVID-19. "The demand and need is near infinite, and if you think about what it would take to have safe return-to-school, return-to-work programs where everyone is getting tested weekly or even more frequently, there's no single solution that can satisfy that," he said. "We need to have multiple solutions to make it happen."