NEW YORK – Vision Medicals has received the CE-IVD mark for its SARS-CoV-2 Clinical Sequencing assay, which uses next-generation sequencing.
The test is built on a proprietary metagenomic sequencing assay that runs on an Illumina NextSeq sequencer. Each kit contains 36 tests and is able to detect SARS-CoV-2 at a sensitivity of 500 copies per milliliter. With the CE mark in hand, Vision Medicals plans to focus on the European market.
The startup, based in Guangzhou, China, has been developing a CRISPR-based diagnostic test for tuberculosis. Last September, the firm raised $14 million in a Series A financing round.
Vision Medicals also recently published a preprint on a CRISPR-based SARS-CoV-2 diagnostic test, named CRISPR-nCoV, which is different from its CE-marked test.