UPDATE: Thank you to everyone who supported our Indiegogo campaign. Through the combined efforts of the public and ourselves, we are progressing forward towards developing a test for Zika Virus. Stay tuned for further developments.
Ubiquitome has launched a crowdfunding campaign on the Indiegogo platform to accelerate the manufacture of an FDA-authorized Zika mobile molecular diagnostic test to be available to U.S. citizens before more than 200,000 Americans visit Brazil for the Rio Olympics.
Zika virus disease (Zika) is a disease caused by Zika virus that is spread to people primarily through the bite of an infected Aedes species mosquito. Outbreaks of Zika have been linked with autoimmune disease Guillain-Barré syndrome and an increase in babies born with microcephaly.
Click on the GenomeWeb logo to read their article about the campaign
We've received our first piece of media coverage on our Indiegogo Campaign. Respected biotech GenomeWeb loves our campaign and gave it in-depth coverage, and it has been one of their top rating articles since.
To pre-order your Zika test, click here.
Here is the article, written by Madeleine Johnson:
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.
The U.S. Army Contracting Command announced its intent to enter into an Agreement (Section 815 Other Transaction (OT)) with the National Chemical and Biological Defence Consortium (NCBDC).
The NCBDC is an industry consortium that is forming, of which Ubiquitome is a member, specifically in response to the agreement. It is a collaborative group of professionals who can bring their knowledge and expertise together to answer problems that the government poses (specific to chemical and biological).
The consortium encompasses the expertise, knowledge, technologies and innovation that the government requires in terms of the technological advancements needed to enhance the mission effectiveness of military personnel.
As a member of the consortium, Ubiquitome is excited about the opportunities that this will present. For Ubiquitome, this opens doors to provide technology and expertise to the U.S. Army on some of the biggest chemical and biological defence projects in the world.
To be able to have Ubiquitome’s technology used by one of the largest military groups in the world would boost interest and provide further opportunities for development of current technologies.
It also exposes Ubiquitome to the other members of the consortium, some of the best and brightest in chemical and biological defence. This provides opportunities for information sharing and collaborations as well as opening up themselves to a wider target market.
The Special Notice released by the army cites: “Only one such consortium, the National Chemical and Biological Defence Consortium, encompasses the expertise, knowledge, technologies, and innovation to meet the program objectives and goals of the coordinated research and development program designed to support the Department of Defence’s medical, pharmaceutical, and diagnostic requirements as related to enhancing the mission effectiveness of military personnel. The consortium is comprised of a well-balanced and uniquely qualified mixture of traditional and non-traditional contractors, small and large business, for-profit and not-for-profit entities, and academic organizations.”
For more information on the consortium, visit their website here or view the full announcement can be viewed here.
Our partners at IDT (Integrated DNA Technologies) have published an article on the Freedom4 and it's applications in researching the Adélie Penguins in Antarctica. To find the full article click here or else here is a summary of the article.
Developing onsite genotyping of Antarctic penguins
Clade-specific PrimeTime® Custom qPCR Assays
Adélie penguins live on sea ice but breed on ice-free land in Antarctica.
The challenges of developing a conservation program for Adélie penguins
Adélie penguins live only along the coastline of Antarctica and are considered “Near Threatened” , in part, because their sea-ice habitat is vulnerable to changes from global warming. Two genetic variants, or clades, of Adélie penguins have been identified. Understanding population trends across these clades will aid the design of conservation programs for these penguins.
Dr Jonathan Banks, Senior Scientist at the Cawthron Institute (see the Researcher profile), is studying the mating behaviors of Adélie penguins that live around the Ross Sea, approximately 4000 km south of New Zealand. Dr Banks can use DNA samples from feathers to determine whether selected mating pairs of Ross Sea penguins are from one or both Adélie clades. This process is complicated as the mating season is short and usually one of the mating pair feeds at sea while the other incubates the pair’s eggs on land. Having access to onsite molecular testing would simplify sample processing and ultimately increase the number of mating pairs that could be included in this project.
Selecting robust qPCR assays for a mobile PCR thermal cycler
In collaboration with Dr Jo-Ann Stanton (University of Otago; Otago, New Zealand) and Dr Elisabeth Wagner (IDT; Coralville, IA, USA), Dr Banks has validated qPCR assays that distinguish the two Adélie penguin clades. By comparing genetic sequences from the two penguin types, Dr Wagner helped identify potential primer sites targeting the penguin mitochondrial genome. They identified a 138 nucleotide sequence within the d-loop region that varied between the two Adélie penguin groups and designed qPCR primers specific for each clade. Before use in the field, Drs Stanton and Banks validated the rigor of the SYBR® Green–based assays using archived penguin DNA stored under variable conditions. High resolution melt curves distinguished true positive results from amplification of primer-dimers. Clade identification results using the selected PrimeTime qPCR Assays completely corroborated data obtained by DNA sequencing. Full details of the assays are to be published in the New Zealand Journal of Zoology.
As a finalist of the Freedom for You grant sponsored by Ubiquitome, Dr Banks wants to use the Ubiquitome Freedom4 device (see the sidebar, From benchtop to handheld, battery-operated instrument) with the PrimeTime®qPCR Assays to perform onsite molecular genotyping in Antarctica. “Significant time and resources can be saved by eliminating the long, complex transport chain. Helicopters, light aircraft, and intercontinental aircraft are all required just to get samples to the New Zealand laboratory, and then return results to me in Antarctica,” notes Dr Banks.
Field testing around the world
Several researchers around the world wish to incorporate the Freedom4 device into field testing projects. To learn more about Dr Banks’ research and additional field application stories that use the Freedom4 device, visitwww.UbiquitomeBio.com.
To read about the successful use of PrimeTime qPCR Assays with different species, instruments, and probe and intercalating dyes, see the list of peer-reviewed research articles on the PrimeTime citations page. The Related reading section below provides qPCR education and support materials for both novice and experienced qPCR researchers.
Campylobacter is the most common food-bourne infection in the world, and this is especially true in Europe with hundreds of thousands of cases of campylobateriosis seen each year. From a significant increase in cases in 2013, incident rates have been falling and, thankfully, are now back under the 2012 level. However campylobacter infection rates are still significantly higher than salmonella infection which sees only around 80,000 cases each year throughout Europe. New proactive testing methods for campylobacter are being brought in to test poultry, the principal source of infection, prior to slaughter and this can account for the reduction in incident rates since 2013.
These new proactive testing methods are as follows: Samples are taken from poultry and transported to nearby laboratories where they undergo PCR testing to determine whether or not campylobacter is present. The results of positively identified samples are returned to the farm sites where corresponding animals are separated from the main flock and instead of these animals being slaughtered for mass fresh chicken distribution they are utilised as processed meats. This method of testing has shown good results, but there are some major issues with it. The turnaround times for sample results are fine when testing laboratories are close to the farm. But for more remote farms, this is not a viable option, unless animals are placed in holding cages for quite a long time. There are also accuracy issues with quite a few infected animals being missed or misidentified. Misidentification has been attributed to the transportation of the samples or the initial sample gathering.
TNO lead researcher, Jos van der Vossen is investigating ways to speed up the testing process and improve the accuracy of identifying campylobacter in poultry through the use of mobile PCR testing.
By utilising a mobile qPCR testing device, remote locations would have the same access to fast results, better incentivising the testing process. It would also improve the overall accuracy with equivical samples able to be retaken immediately combined with the accuracy of qPCR itself being very high.
Campylobacter is an infectious disease that can incapacitate someone for a week or more with diarrhoea, vomiting and abdominal cramps. By providing accurate on-farm testing methods, the incident rate of campylobacter can be reduced even further, helping to control or eliminate this common food-bourne infection. Rather than testing the meat once it has been processed and distributed, testing the poultry while still alive can ensure that no part of an infected animal is used unprocessed. Effective implementation of animal testing can give people better peace of mind that the food they are eating is disease free, with an overall reduction in health costs throughout Europe.
Ubiquitome is running a grants program for research groups who would benefit from a mobile qPCR device. Jos van der Vossen has been chosen as one of the finalists. To find out more about the program and view the other finalists, visit the website here.