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Prenetics Gets CE-IVD Mark for Handheld, Reusable SARS-CoV-2 Test System

NEW YORK — Prenetics said on Tuesday that it has received CE-IVD marking for its Circle HealthPod point-of-care SARS-CoV-2 testing system.

The handheld, reusable system uses reverse-transcription, loop-mediated isothermal amplification to detect SARS-CoV-2 RNA in nasal swab specimens placed in single-use test capsules, providing results within 20 minutes. It was developed by University of Oxford spinout Oxsed, which Prenetics acquired in late 2020.

Prenetics noted that the system has shown 96 percent sensitivity and 99.9 percent specificity and is designed to be used more than 1,000 times. It is being commercialized in partnership with New World Development, a Hong Kong-based firm that owns and operates retail and residential properties.

Prenetics said that New World Development has acquired 10,000 Circle HealthPod systems and 60,000 COVID-19 test capsules with a total retail value of HK$16.5 million ($2.1 million), which will be offered at its retail locations. The test is also being offered directly to Hong Kong consumers online, with planned commercial rollouts in the US and UK in the future.

Hong Kong-based Prenetics said it also aims to develop Circle HealthPod test capsules for the detection of other infectious diseases such as influenza and sexually transmitted diseases.