NEW YORK — Diazyme Laboratories said on Thursday that it signed an agreement to market and distribute Maccura Biotechnology's SARS-CoV-2 molecular diagnostic in the US.
Specific terms of the deal were not disclosed.
The fluorescent PCR-based test, which received Emergency Use Authorization (EUA) from the US Food and drug Administration in April, is designed to detect the SARS-CoV-2 ORF1ab, N, and E genes in upper respiratory specimens. It runs on Thermo Fisher Scientific's Applied Biosystems 7500 RT-PCR system and may be used by any lab CLIA-certified to perform high-complexity tests, according to Chengdu, China-based Maccura.
Earlier this month, Poway, California-based Diazyme received EUA for its SARS-CoV-2 antibody test.