Dr. Damien Kenny:

I am grateful to the committee for allowing us to present today. I know all the members are very busy. As widespread vaccination facilitates emergence from the restrictions imposed by the Covid pandemic, most will agree that some form of testing is essential. However, the debate on testing seems to have focused on which testing system is best, rather than on which is most appropriate for the given circumstances. Nuevo Ireland is a biosecurity firm and we are presenting our mobile, real-time PCR testing system. We believe this can contribute to facilitating a safe return to international travel, which we all understand is essential moving forward. The system has been approved by the US Food and Drug Administration, FDA, and Health Canada. It is CE-marked and has been validated across two separate laboratories testing four different lab-based systems, with an extraordinarily high sensitivity and specificity of approximately 99%.

The system consists of four main components. The first is the M1 sample prep cartridge, which allows purification of the raw sample, usually a nasopharyngeal aspirate. Then there are the go-strips, which the committee will have seen in the presentation we sent. These contain the agents to process the purified sample and allow amplification of the ribonucleic acid, RNA. The Franklin thermocycler then rapidly heats and cools the RNA to allow significant and exponential amplification of any RNA that may be present in the sample. This a mobile, battery-operated system that is carried around in a suitcase and weighs approximately 2 kg. The Biomeme software allows quantitative and qualitative interpretation of the results, which are usually available within 60 to 70 minutes of the test sample being processed.

We have begun to test in Ireland. We wish to emphasise that this is an accurate, convenient, rapid and gold standard PCR system. We acknowledge that this testing takes place outside the classical laboratory setting but we should all recognise that there are multiple examples of how in vitrodiagnostics have successfully moved outside a laboratory setting over the past number of years, including with urine testing, breath testing, blood testing and now even diagnostic ultrasounds. We are talking about providing this gold standard opportunity to evaluate for SARS-CoV-2 as a screening tool. That is where its significant strength lies. The types of assays we use, and the fact we are testing for not only the spike protein but another target on the SARS-CoV-2 virus RNA, have facilitated us picking up all known variants to date. Multiple other studies are going on to continue that work based on evolving variants. One of the things we feel is essential, particularly from a travel and transport perspective, is not only that we are accurate but that we are accurate across evolving variants of SARS-CoV-2. As we have seen in the past, different variants coming into our country can lead to a significant spike in infection rates and clinical outcomes.

I do not have much more to say about the system. I would be very happy to take questions, unless Mr. Lord would like to provide any other information.