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.
With the Rio Olympics only months away, Ubiquitome wants to reduce the potential impact of Zika by making a diagnostic test widely available. By knowing whether or not they have contracted the virus, people can get treatment and minimize the risk of infecting others.
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Ubiquitome was formed to realize a vision of ubiquitous genomics. For serious diseases like Zika that means giving people access to a test faster, cheaper and more flexibly.
The US Food and Drug Administration (FDA) have invited organizations like Ubiquitome to develop tests for Zika through its emergency use authorization (EUA) process. We are currently developing a test and need funding to get our test authorized by the FDA. Our plan is to make the tests available throughout the US and ultimately anywhere in the world by leveraging our mobile molecular testing technology.
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Ubiquitome is pioneering mobile molecular testing to detect pathogens like Zika. The company’s first product - the Freedom4 - is the world’s first mobile, handheld DNA testing device. Based on real time PCR, it offers gold standard performance, eliminating the delays encountered with today's laboratory-based testing.
Towards the end of 2015, we developed a test for Ebola and demonstrated the capacity of the Freedom4 to perform at the same level as gold standard instruments with unprecedented mobility and responsiveness. The FDA’s call for diagnostic tests for Zika, and the clear need for tools to stop the Zika outbreak, especially with the Olympics only a few months away, is the primary motivation for our campaign.
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The Zika test Ubiquitome is developing is based on real time PCR (RT-PCR). Real time PCR is the most common type of molecular diagnostic and is often used to diagnose viral infections like Zika.
Ubiquitome has developed the world’s first commercial mobile, handheld real time PCR device, the Freedom4. The Freedom4 uses a laser to illuminate the sample. Zika virus has its own unique genetic signature that when combined with the test being developed by
Ubiquitome, reflects light to an optical sensor and is detected by the Freedom4.
Once it is authorized by the FDA, Ubiquitome plans to make the Zika test available on the Freedom4, as well as within the US through a CLIA certified laboratory, in time for the Olympics.
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It is becoming clear that Zika may have serious health impacts. Knowing your status allows you to have informed discussions with your medical provider, as well as your family about how to mitigate the potential impact of your infection. For more information on Zika, we highly recommend this interview from The Centers for Disease Control and Prevention head, Tom Frieden.
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This infographic from the Economist shows the risk of the Zika virus spreading.
Zika is a disease transmitted by Aedes mosquitoes. Symptoms can include mild fever, skin rashes, conjunctivitis, muscle and joint pain, or headache. These symptoms normally last for 2-7 days. The virus is circulating in Africa, the Americas, Asia and the Pacific.
Outbreaks of Zika have been linked with the autoimmune disease Guillain-Barré syndrome (GBS) and an increase in babies born with microcephaly.
According to the World Health Organization there is no specific treatment or vaccine currently available. They recommend the best form of prevention is protection against mosquito bites.
While Zika is transmitted to people through the bite of an infected Aedes mosquito, sexual transmission of Zika virus has also been reported.
Zika virus diagnosis can only be confirmed by laboratory testing for the presence of Zika virus RNA in the blood or other body fluids, such as urine or saliva. According to the FDA, ‘there are no commercially available diagnostic tests cleared by the FDA’.
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Over 10,000 athletes will compete at the Rio Olympics from 5 August to 21 August 2016 in Rio De Janiero, Brazil, center of the current Zika outbreak. Up to 500,000 more fans, officials and other supporters will also attend. 200,000 of these are expected to be from the USA.
While the Zika virus does not pose any major health risks directly to the people
contracting it, the downstream impact of the virus, especially on pregnant women, is worrying health officials. Testing is seen as one way of reducing the global spread of Zika post-Olympics.
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We will use your money to accelerate our product development program, get validation of our Zika test, and submit it to the FDA for authorization.
The more money we raise the faster we will be able to bring our Zika test through the authorization process and get it into the hands of the people that need it.
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Ubiquitome is a New Zealand-based developer of handheld, cloud connected real time PCR devices. The company’s Freedom4 is the first commercially available handheld, battery powered device to offer gold standard real-time PCR performance wherever it is needed. Visit www.ubiquitomebio.com.
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The Ubiquitome team comprises top scientists and engineers in the US and New Zealand, including the inventors of the technology at Otago University, one of New Zealand’s top health research Universities. Our disciplines cover molecular biology, virology, mechanical engineering, electrical engineering, optical engineering and manufacturing engineering.
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1. Where do I get a test done?
We will mail you a package so you can provide a sample at your convenience. This is then sent to our laboratories where the results will be analyzed and provided to you or your physician as appropriate.
2. What countries is it available in?
Upon FDA authorization the test will initially be available only in the US, although we plan to add additional jurisdictions subject to appropriate regulatory requirements.
3. How reliable is the test?
In general, molecular diagnostic tests are some of the most accurate, sensitive and reliable tests
for viral infections like Zika. Specific data around this will be part of our FDA submission and will be made available at the time of authorization.
4. Is the test FDA approved?
Not yet. Our intention is to seek authorization for our test from the FDA through its
emergency use authorization mechanism.
5. How confident are you that the test will be authorized and available in time for
the Olympics?
We offer no guarantees that our test will be authorized or available in time for the Olympics, however we have had very promising outcomes from a validation study around Ebola. The FDA also focuses resources on emergency use authorization filings to expedite authorization of new diagnostic tests. Both factors give us reasonable confidence that our test will be authorized and available for the Olympics.
6. Can I get Ubiquitome's mobile molecular test?
We plan to make the mobile molecular test based on the Freedom4 available following FDA authorization.
7. I have another really important application for the Freedom4, how can I get one for this?
Follow-up with us at www.ubiquitomebio.com. Please note that the Freedom4 is an investigational use only device. Its performance characteristics have not yet been established.