Oxford Nanopore Technologies has secured CE mark approval for LamPORE test for the detection of SARS-CoV-2 virus, which is responsible for the Covid-19 disease.
LamPORE is said to be a rapid, scalable and precise test for the identification of the SARS-CoV-2 virus.
The company has designed the LamPORE test to carry out on GridION desktop device or MinION Mk1C palm-sized device.
Based on an application of the UK’s MHRA, the LamPORE assay is currently CE marked for in vitro diagnostic use to identify the SARS-CoV-2 virus using the GridION device.
Oxford Nanopore seeking regulatory approvals for LamPORE test in other countries
The company also filed applications to secure regulatory approvals for the test in other countries, including emergency use authorisation (EUA) in the US.
Oxford Nanopore, along with its partner G42, submitted an application for regulatory approval in the UAE.
According to the company, LamPORE demonstrated a sensitivity of 99.1% and specificity of 99.6% in a study of over 500 samples.
With initial use in the UK, Germany, Switzerland and UAE, LamPORE is currently introduced across the globe.
In February 2019, Oxford Nanopore introduced new ‘109’ cDNA Kits for its real-time and scalable sequencing technology.
The kits provide high throughput whilst generating complete sequences of full-length cDNA strands, with a low input option of just 1ng PolyA+ RNA.
