NEW YORK (GenomeWeb) – Ubiquitome has launched a crowdfunding campaign to support the development and validation of a molecular test for the Zika virus, with the goal of obtaining Emergency Use Authorization from the US Food and Drug Administration prior to the Olympic Games in Brazil this summer.
The New Zealand-based firm currently markets the Freedom4, a portable, battery-operated and iPhone-interfaced qPCR platform that can run four samples at a time.
"We identified an opportunity to tap the crowd and link end-users — people who are worried about [Zika], thinking about going to the Olympics, or are traveling to tropical locations — with the test, and unlock a new source of funds to complement investor funds," Paul Pickering, president and CEO of Ubiquitome, told GenomeWeb in an interview.
"We're excited, and we think that people from the FDA are likely to be excited too, because at the end of the day they understand as well that there are meaningful costs involved [for EUA] and those funds have got to come from somewhere," he added.
Ubiquitome began development an Ebola test for potential EUA during that outbreak, but did not ultimately achieve its goal before the outbreak came under control. "It's not a trivial process," Pickering said. Even with the expedited approval mechanism, development, validation, and regulatory support require quite a lot of resources. The process varies by disease, particularly with respect to cross-reactivities, but, "At a high level, the FDA wants to know you've got something that is sensitive and specific," Pickering noted.
And while investors in companies developing infectious disease diagnostics may be excited by EUA, the returns "are best described as volatile," Pickering said, dependent on duration and extent of an outbreak. "It was really great the Ebola outbreak was gotten under control, but I doubt many companies made much money out of [EUA] to return to investors," he said.
Crowdfunding, meanwhile, is a "huge, new pool of financing for startup companies, in a broad and diverse range of areas," Pickering said.
Crowdfunding is a newer strategy in the medical device space. To help commercialize a small benchtop thermal cycler called miniPCR, Amplyus recently raised about $66,000 on Kickstarter, more than three time its original goal. Chai Biotechnologies sought $50,000 from crowdfunding for its Open qPCR system, and raised just over $202,000.
Pickering said there have been a few firms who have used crowdfunding for pre-FDA programs, promising to deliver an innovation, sometimes several years in the future, but the Ubiquitome campaign may be the first molecular diagnostic to attempt this.
A lab-developed test might be another mechanism to commercialize a Zika assay, but, "The FDA is pretty firm that companies work through the [EUA] process," Pickering said, noting that a test offered as an LDT by a hospital in Houston but based on a CE-marked test kit merited an untitled letter from the agency earlier this month, although it may very well have met the CLIA standards for the state of Texas.
Besides being a good corporate citizen and helping save lives, a handful of companies may ultimately commercialize tests after receiving EUA, as happened during the H1N1 outbreak in 2009-2010. Validation studies for EUA might also be used for future applications, and investors and partners may look favorably on achieving this type of authorization.
"They're seeing that the FDA is engaged, and if one makes it all the way through that's a checkmark of sorts — it's not a 510(k) or a [pre-market approval], but it is a way to kind of get some runs on the board," Pickering said. The process also helps companies, particularly those in early stages, to develop relationships with the FDA. Furthermore, Pickering said the agency dedicates significant resources to expediting approval through the EUA process.
The Ubiquitome Zika assay will need to be tested for cross-reactivity to pathogens like dengue, malaria, and chikungunya. "It's quite a lot of lab work, and, it's probably not appreciated, but it's quite a significant validation process." The firm has completed the in vitro work on the test but has not begun the validation stage yet.
The test will be developed for the Freedom4 platform, but contributors who donate $25 to the crowdfunding campaign will get on a list for future testing. The test would be made available through a centralized laboratory, should it become authorized, Pickering said.
Ubiquitome's Zika test will use saliva, and thus contributors would ship samples to the centralized lab, although this may require a physician prescription depending on the state.
Making the test available on a mobile molecular basis is a less well-worn path, however, and how that will look in the future will be part of the firm's discussions with FDA.
Ubiquitome expects that with full funding it can have a test available in August, in time for the Olympic Games in Brazil.
However, "We want to be very clear, and we've got this caveat on the [fundraising site] as well, that we don't offer any guarantees that it will be available and it is subject to FDA authorization."
Uptake of portable molecular
Ubiquitome has seen the development of a number of applications for the Freedom4 since its launch, in areas including conservation biology, forensics, food and environmental testing, animal health, and clinical applications, according to its website.
The platform is a somewhat disruptive technology, however. Particularly for those that want to take advantage of the mobile molecular testing capability, some customers find up-front sample preparation technology "hasn't caught up [and] it isn't as mobile as the Freedom4," Pickering said.
Direct amplification — using robust enzyme technology and methods to manage inhibitors — may be a way to address this, and that is what the firm is hoping to deploy with its Zika saliva test, Pickering said, adding that developments in mobile sample prep are being catalyzed by mobile PCR becoming more of a reality.
The pricing of the Freedom4 platform remains around $25,000, but the company has also been doing some work with manufacturing partners to bring the cost down. "To make it ubiquitous, we also need to make it affordable," said Pickering.
The firm is continuing collaborations with Integrated DNA Technologies and food safety firm AssureQuality. In addition, Ubiquitome continues to get "a lot of interest, as we expected when we launched the Freedom4, from companies that have test content," Pickering said.