AUCKLAND, New Zealand
Testing people for SARS-CoV-2 (COVID-19) has just been made easier and more accessible with United States Food and Drug Administration (FDA) emergency use authorization (EUA) of the combination of SalivaDirect™ with Ubiquitome’s Liberty16 mobile real time-PCR.
SalivaDirect was developed by a Yale School of Public Health team, headed by ex-pat New Zealander Dr Anne Wyllie, to reduce access challenges inherent in nasal swab based COVID-19 testing.
Saliva samples collected for testing by SalivaDirect do not require healthcare worker assistance, preservatives, or specialised equipment for nucleic acid extraction.
Dr Wyllie was approached early in the pandemic by the US National Basketball Association and its players’ association to validate the saliva-based protocol in asymptomatic individuals. SalivaDirect is now used in more than 120 US labs designated by Yale.
It has also been authorised for sample collection using the Unsupervised Collection Kit (for sample drop off) and SalivaDirect At-Home Collection Kit (mail-in testing), as well as in asymptomatic individuals.
Dr Wyllie says she realized early in the pandemic that there was no reason for SARS-CoV-2 tests to be so expensive. SalivaDirect then became a public health driven ‘mission’. The team conducts its validation work at no cost to labs and does not charge agreement or licensing fees.
“However, costly instruments for real-time PCR analysis often stand in the way of equitable access for under resourced communities and countries and sustainability of testing systems,” Dr Wyllie says.
Public health officials throughout the world have expressed concern about inequities in the COVID-19 response. Recently, the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme (IOAC) called on the international community to reduce the socioeconomic impacts of the global pandemic.
Dr Wyllie says she saw potential for the Liberty16 RT-PCR system. New Zealand-based Ubiquitome was one of the only international companies selected by the US National Institutes of Health’s RADx initiative to speed innovation and commercialization of technologies for COVID-19 testing.
The Liberty16 is designed to bring mobility to PCR testing and reduce cost. The PCR is handheld, can run on battery power and connects to its own iPhone app, which shows the result of tests to operators easily trained to run the Liberty16 and the iPhone app.
In its filing with the FDA, the Yale team demonstrated the singleplex SalivaDirect protocol performed on the Liberty16 yielded test results for SARS-CoV-2 comparable to bigger, immobile instruments.
Dr Paul Pickering, CEO of Ubiquitome, says collecting saliva samples, analysing them in the Liberty16 and getting the result spelled out on the iPhone app, allows for outbreaks to be identified anywhere there is cell phone reception, by labs with SalivaDirect authorisation.
“That’s important for quickly limiting the spread of COVID-19 when the alternative is waiting sometimes days for results as the nearest testing laboratory is hours away.
“With Liberty16 units costing a fraction of the large, lab-based units, it means access to RT-PCR testing can be improved for millions of people in under resourced communities.”
Yale researcher Devyn Yolda-Carr, who has led many bridging studies to expand the SalivaDirect protocol to labs and their equipment, says the Liberty16 presents an affordable solution to the access problem without compromising performance.
Its Liberty16 open system RT-PCR offers rapid, mobile testing for COVID
Auckland, New Zealand, October 7, 2020: New Zealand-based Ubiquitome is ramping up production of its mobile, real-time (RT) PCR technology with funding from the United States’ National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative.
Ubiquitome is the only NZ private company to be accepted into the highly competitive RADx and to receive federal funding through the NIH in recent years.
As one of the first RADx-Tech contracts awarded outside the US, Ubiquitome will scale its Liberty16 mobile PCR technology to enable thousands of tests per day by the end of the year.
The Liberty16 will be targeted for use by rural and metropolitan hospitals and mobile labs to test for SARS-CoV-2 - the virus that causes COVID-19
Ubiquitome’s device can detect virus in 16 samples in 40 minutes or less. It reports positive or negative results via its proprietary iPhone app.
Battery-operated, less than the height of the latest iPhones and weighing only 2.5 kg, the Liberty16 is one of the smallest open system RT-PCR systems on the international market. It is being distributed in Asia Pacific by Swiss giant DKSH.
In the US initiative, Ubiquitome will be funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services.
Dr Paul Pickering, Ubiquitome’s founder and CEO, says the RADx-Tech process has been running in parallel with evaluation of the Liberty16 for emergency use approval by the US Food and Drug Administration (FDA).
Dr Steven Kazmierczak, Professor of Pathology at Oregon Health & Science University, led clinical studies on the Liberty16 as part of Ubiquitome’s FDA application. His interests include quality control, point-of-care testing, laboratory error, and method evaluation.
“The Liberty 16 came through as fast, accurate and competitive for the cost of testing and the device itself,” Dr Kazmierczak says.
When launching the US$1.5 billion RADx initiative, NIH said it would propel the technologies developed working closely with US agencies.
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AUCKLAND, New Zealand
Ubiquitome has signed an exclusive agreement for Swiss headquartered DKSH to market and sell its mobile, battery powered COVID-19 tester, Liberty16, in several Asia Pacific countries.
Swiss giant DKSH signs agreement to market Ubiquitome's mobile, battery powered, PCR COVID-19 fast tester, Liberty16, in the Asia-Pacific market as manufacturing is ramped up with NZ$578,000 backing from the NZ government.
DKSH, also known as DiethelmKellerSiberHegner, is a market expansion services group listed on Switzerland’s main stock exchange, the Six Swiss. The group reported revenue of CHF11.57 billion (US$11.9 Billion) for FY2019. Significant shareholders in DKSH operate through investment managers such as the Central Bank of Norway, BlackRock Inc, Credit Suisse, and AXA Investment Managers.
DKSH’s Singapore-based Business Unit Technology, will provide marketing and sales, and distribution and logistics as well as after-sales services for the Liberty16 in Australia, Cambodia, Indonesia, Laos, Malaysia, Myanmar, New Zealand, Philippines, Singapore, Thailand, and Vietnam. DKSH will also seek regulatory approval in each of the markets for the use of the solution.
The Liberty16 is a handheld, battery-powered, real-time polymerase chain reaction (real-time PCR) device that can fast test and relay sample data via an iPhone app, all potentially within 40 minutes.
The device is called Liberty16 because it can run 16 tests at the same time. It is a miniature DNA photocopier that can amplify specific target DNA sequences to show the presence of any DNA of interest, whether that be human, animal, or wider environmental pathogens.
Hanno Elbraechter, head of Business Unit Technology, says developing DKSH’s life science business and providing more innovative solutions for its business partners is a strategic focus.
“Ubiquitome’s solutions can be applied in various industries such as clinical diagnostics, food and beverage and life science research. We look forward to successfully growing the business with Ubiquitome in the APAC region,” Mr Elbraechter says.
Paul Pickering says with the DKSH partnership, Ubiquitome will have unparalleled market coverage in the APAC region.
Dr Pickering says the $528,927 in NZ government funding will help with emergency Food Drug Administration (FDA) authorization and deployment of community testing for COVID-19. Ubiquitome believes Liberty16 has real potential for border testing, with it being able to rapidly test samples from international arrivals.
Ubiquitome is receiving just over half a million dollars in Government funding to help with increase the manufacturing capacity of its Liberty16 rapid COVID-19 testing device in Auckland.
Paul Pickering, chief executive of Ubiquitome, says the mobile device would be ideal for use in places like airports, pre-screening international travellers once borders reopen. Passengers could be tested and would get the result before their flight, indicating whether they should travel or not.
“COVID-19 is the virus of the moment, but there will be others in the future that we’ll need to protect ourselves from, so I’d see pre-flight health checks being normalised the same way more stringent security processes were normalised following 9/11,” Dr Pickering says.
“We can test and get results in under an hour with the Liberty16. We aim to show appropriate airport or border control personnel could be trained to run the device. The Liberty16 software interprets the data so the airport personnel just get a result that shows if the person is positive for COVID-19 or not.”
The Liberty16 is a real-time PCR (polymerase chain reaction) device that connects via Bluetooth to its own proprietary iPhone App for run set-up, real-time observations and post-run data analysis. It is battery-operated and, weighing in at 2.5 kg and with a footprint of just over 1/3 of an A4 sheet of paper, it is one of the smallest real-time PCR systems on the international market.
Ubiquitome has already sold Liberty16 into research and clinical labs in Japan, US, Canada, United Kingdom and Germany. It is used by the labs to amplify specific target DNA sequences, to show the presence of any DNA of interest whether that be human, animal, or wider environmental pathogens. An earlier prototype was successfully tested for Zaire ebolavirus.
Pickering says the $528,927 government funding will also help with emergency Food Drug Administration (FDA) authorisation and deployment of community testing for the Liberty16.
Apart from airports, Pickering says the device was identified in the UK for its potential in testing front line medical staff before they start work.
Original story featured in Genomeweb.
Ubiquitome said on Tuesday that the New Zealand Health Research Council and Health Ministry is funding research that pairs the company's handheld PCR device and Oxford Nanopore's Flongle sequencer, which can be used for viral genotyping.
The NZ$165,000 (US$98,141) grant will fund Massey University researchers aiming to enable one person to screen more than 500 samples and obtain 24 whole genome sequences per day. The research is also validating minimal-extraction and extractionless methods, such as heat treatments, for RNA sample preparation to address the shortage of reagents for SARS-CoV-2 tests.
In the short term, the Liberty16 will be used to disperse screening for SARS-CoV-2 detection, and additional data from the viral genotyping will "support more efficient tracking and tracing of disease contacts," a spokesperson from Ubiquitome said. The data collected will also contribute to longer-term research into disease epidemiology, the spokesperson added.
Ubiquitome's Liberty16 device is a handheld, battery-powered real-time PCR device that can test and relay sample data through an iPhone application. The device is commercialized for research use only in Japan, the US, Canada, the United Kingdom, and Germany. The company also previously said it intends to apply for Emergency Use Authorization in the US.
"What we can do is narrow the time between infection, diagnosis, and source and contact tracing," said Ubiquitome's Chief Scientific Officer Susan Turner. "To achieve this we need technologies that enable widespread access to affordable, line-of-sight diagnostic testing, rapid turnaround of results, and efficient methods to track and trace viral transmission."