NEW YORK – Genetic Signatures said Wednesday it has received the CE mark for its severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) detection kit, enabling the kit to be marketed in the European Union and other countries that recognize the designation.
Using samples collected from nose or throat swabs, the kit can run on Genetic Signatures' highest throughput instrument, the GS-1000, which can process about 1,500 samples in a 24-hour period, in a fully staffed laboratory and in batches of 188 samples per run, the firm said.
Genetic Signatures CEO John Melki said in a statement that the "new molecular test will give healthcare workers in Europe a high-throughput and accurate diagnostic solution to help combat this virus."
The kits leverage the company's patented 3base technology, which shortens genetic codes from four letters to three, reducing the genetic complexity of infection detection in molecular testing.
Melki said he anticipates an acute period of testing for the next six months or more, when demand for coronavirus testing could continue to exceed supply. After this time, he said, the firm intends to merge the SARS-CoV-2 test with its respiratory disease testing kit.
The firm said it has shipped its first SARS-CoV-2 tests to Europe and is in negotiations with potential customers in Germany, the UK, and Spain.
The New South Wales, Australia-based company announced Monday that it had applied for approval for its SARS-CoV-2 RT-PCR assay in Europe and with the Australian Therapeutic Goods Administration, and that it anticipates applying to the US Food and Drug Administration for Emergency Use Authorization.
In November, the company closed a $25 million financing that it anticipates using to fund expansion in Europe and the US.