Universal Biosensors, Inc. (ASX:UBI) has entered into a global exclusive License Agreement with IQ Science Limited for commercialisation of a SARS-CoV-2 N-Protein (COVID-19) detection test for the virus that causes COVID-19.
The COVID-19 Test will use UBI’s proprietary electrochemical strip and device technology designed to provide a positive or negative result as to a patient’s viral status within 30 seconds (based on internal validation work performed to date) from a small saliva sample. UBI’s electrochemical test method also has the potential to measure the relative viral load associated with a patient’s infection status.
UBI has been working with Dr Shalen Kumar of IQ Science for six months performing due diligence on the aptamer technology and the performance quality of IQ Science products. IQ Science was founded by Dr Kumar in 2020. Dr Kumar is a leader in the field of aptamers and a specialist in the generation of ssDNA aptamers capable of binding small molecules for applications in diagnostics platforms.
He has over 12 years’ experience in the field of aptamers with 8 patent inventions and has successfully developed ELONA assays, Microfluidic systems, Electrochemical biosensing and lateral flow assays. IQ Science has a small number of highly specialised staff working exclusively in the field of aptamer development.
The License Agreement includes the following commercial terms:
The deal with IQ Science is an important breakthrough for UBI since it will be the first time our platform will use aptamers as a detection technique. Aptamers are a next generation biorecognition element which when combined with our existing technology platform should allow us to detect and measure a large number of targets. Based on what we know is available in the world today, a COVID-19 Test offering an accurate result within 30 seconds of the patient sample will be the first of its kind globally,” John Sharman, CEO of Universal Biosensors, said.
“UBI has completed initial feasibility work on the SARS-CoV-2 N-Protein based test over the last six months and we have shown that we can generate a positive or negative COVID-19 response within 30 seconds from a small saliva sample. Our initial feasibility work which comprised approximately 100 tests (carried out as per ISO13485) has shown the necessary sensitivity (1.4 fg/mL) but we still need to confirm the test’s specificity. The test performance is predicted to have similar limits of detection to the Gold Standard RT-PCR methods. There are several manufacturing issues that are being addressed in parallel with the ongoing work to get our N-Protein COVID-19 test strip ready for commercialisation, including confirming the test strip stability.”
“The market for COVID-19 testing is estimated to be US $19 billion in 2021. Recent events, including the response to Omicron, suggest that the demand for COVID-19 testing will remain significant at least for the next five years. Subject to further internal and clinical testing, our initial estimate is that we should have a product ready for market in the next nine to 18 months.”
Current rapid antigen tests for COVID-19 have limited sensitivity and take 15 to 20 minutes to prepare a sample and get a result. PCR testing is much more sensitive and accurate but can take days and is very expensive. This makes current tests impractical to use in situations where a COVID-19 Test result is needed instantly in order to make better decisions about safety. This includes when frontline workers and first responders initially engage members of the public, or for high-throughput, broad-based screening at public venues, airports, within the workplace, and at schools and universities. A COVID-19 Test that could be performed in 30 seconds with high-sensitivity and accuracy would represent a fundamentally new capability to improve public health and safety.