Ubiquitome gets FDA authorization with Yale SARS-CoV-2 self-collection tests

NIH RADx winner�s next gen Liberty16 Pro gets EUA

AUCKLAND, New Zealand–(BUSINESS WIRE)–#COVIDCATCHER–Ubiquitome’s next generation real time PCR device system, the Liberty16 Pro, has been given Emergency Use Approval (EUA) by the United States Food and Drug Administration (FDA).

Paul Pickering PhD, CEO of the New Zealand medical device manufacturer, says the multiplex Liberty16 Pro’s listing is part of the successful application by the Yale School of Public Health to have its SalivaDirect At-Home Collection Kit for qualitative detection of nucleic acid from SARS-CoV-2 in saliva authorized.

“Not only is the SalivaDirect protocol faster on the Liberty16 Pro, with multiplexing enabled we more than double the samples per run and open the door to testing for other targets in the same sample,” Dr Pickering says. “Recently influenza and RSV outbreaks have been detected at the same time.”

This is the second EUA Ubiquitome’s devices have received working with the Yale protocol, which was developed by a team led by another New Zealander Anne Wyllie PhD.

Yale’s SalivaDirect At-Home Collection Kit allows people over 18-years-old to collect their own saliva, and options for adults to help collect it from anyone younger.

Ubiquitome first came to notice in the United States when it won through the National Institutes of Health RADx shark tank COVID innovation initiative in 2020, one of only a handful of international companies to win.

Multinational companies have used the PCR device systems for surveillance after first dividing their workforce into separated teams. Selected staff get trained on how to collect individual’s saliva samples and put them through the device systems in pooled batches. The results of the tests are delivered via proprietary software installed on any iPhone or iPad.

Dr Pickering says it is fantastic to see Ubiquitome’s name again listed by the FDA alongside some of the world’s biggest PCR manufacturers.

“We are grateful to the international scientific community for the rigour that has been applied and the acceptance that a New Zealand company can develop and manufacture a world-class medical device,” he says.

*For research use only. Only for diagnostic use for qualitative detection of nucleic acid from SARS-CoV-2 in saliva in laboratories designated by the Yale School of Public Health.

Contacts

Dr Paul Pickering

CEO Ubiquitome

Tel: +64 27 965 4812

Email: pj.pickering@ubiquitomebio.com
Website: www.ubiquitomebio.com