NEW YORK — Vela Diagnostics and JN Medsys have received CE-IVD marks for their respective SARS-CoV-2 tests, the Singapore-based companies announced separately on Friday.
Vela's ViroKey SARS-CoV-2 RT-PCR Test detects the virus by targeting conserved regions of its genome and can be used with Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx instrument.
Vela said that an automated version of the test has been developed for use with either the company's Sentosa SX101 instrument in conjunction with its Sentosa SA201 instrument or the ABI 7500 Fast Dx. This test is expected to get CE-IVD marking later this month.
Earlier this week, Vela received a $225,000 contract from the Biomedical Advanced Research and Development Authority to help develop the ViroKey test.
JN Medsys' ProTect COVID-19 RT-qPCR kit is designed to detect the N1, N2, and N3 regions of SARS-CoV-2 in nasopharyngeal swabs specimens using Thermo Fisher's TaqMan chemistry, providing results within two hours.
JN Medsys said that the test has also received Singapore Health Sciences Authority provisional authorization and the Philippines Food and Drug Administration approval.