LamPORE test for SARS-CoV-2 detection gains CE-IVD mark
Fri 9th October 2020
LamPORE is a new, rapid, scalable, accurate test, for the detection of the SARS-CoV-2 virus that causes COVID-19. LamPORE is designed to be performed on a desktop device, GridION, or a palm-sized device, MinION Mk1C.
Following an application to the UK’s MHRA, the LamPORE assay is now CE marked for in vitro diagnostic use for the detection of the SARS-CoV-2 virus, using the GridION device. Further regulatory approvals are being pursued in other countries, including Emergency Use Authorisation in the United States, and with our partner G42 in the United Arab Emirates.
A recent publication showed that in a study of more than 500 samples, LamPORE showed a sensitivity of 99.1% [96.9-99.9] and specificity of 99.6% [98.0-100].
LamPORE is currently being rolled out globally, with initial use in the UK, Germany, Switzerland and United Arab Emirates.