Oxford Nanopore Technologies has secured CE-IVD mark for its LamPORE test that detects SARS-CoV-2, the virus that causes the Covid-19 disease.
LamPORE is a rapid, scalable molecular diagnostic assay for the detection of the SARS-CoV-2 virus.
It is designed to be performed on a desktop device called GridION, or a palm-sized device called MinION Mk1C.
The test targets three highly conserved SARS-CoV-2 genes, minimising inconclusive results and requirement for repeated testing. It can also identify between poorly collected samples and true negatives, using inbuilt control, the company noted.
LamPORE assay has been CE marked by UK’s MHRA for in vitro diagnostic use for the detection of the SARS-CoV-2 virus on the GridION system.
The company is pursuing further regulatory approvals in other countries, including emergency use authorisation (EUA) in the US. It has also partnered with Abu Dhabi-based artificial intelligence and cloud computing company G42 for the clearance for the test in the UAE.
According to the company, the LamPORE test showed 99.1% sensitivity and 99.6% specificity in a study, which evaluated more than 500 samples.
Oxford Nanopore Technologies will roll out the test in the UK, Germany, Switzerland and UAE initially with plans to expand the distribution globally.
In May, Bio-Rad Laboratories received EUA from the Food and Drug Administration (FDA) for its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit for Covid-19 diagnosis.
In April, Mobidiag secured EUA in Finland for its Novodiag Covid-19 diagnostic test, which enables a rapid and fully automated detection of the SARS-CoV-2 virus that causes the Covid-19 infection.
In March, the FDA granted EUA for Abbott’s molecular point-of-care test for detecting Covid-19.