News & Events

SAN DIEGO, CA Severe COVID-19 infection is associated with high morbidity and mortality with 50% of the deaths determined to be due to coagulopathy1. Studies have revealed that patients with serious infection are more likely to have COVID-19 associated coagulopathy than patients with mild infection, and those who die from COVID-19 are more likely to have met the International Society on Thrombos …

SAN DIEGO, CA (July 30, 2020) Diazyme announces partnership with Maccura Biotechnology (USA) LLC, launching a FDA EUA approved SARS-COV-2 RT-PCR diagnostics test. "Here at Diazyme, we continue to address gaps in testing during the COVID-19 public health emergency. The SARS-CoV-2 Fluorescent PCR Kit- Maccura Biotechnology (USA) LLC is a RT-PCR test intended for the qualitative detection of SARS- …

SAN DIEGO, CA  (July 8, 2020) Diazyme announces receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test. The Diazyme IgG test is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer. "Diazyme has been at the forefront of the development effort to bring timely, high quality COVID-19 serology (antibody) tests during the publi …

SAN DIEGO, CA – May 22, 2020 – Diazyme is making a statement to clear any confusion due to FDA’s May 21 press release regarding delisted tests from the FDA FAQ website. Diazyme had two types of tests under Section IV.D notification of FDA’s policy on the public health emergency for COVID-19. The Diazyme high-throughput laboratory run CLIA antibody test is NOT subject of delisting. Diazyme decid …

SAN DIEGO, CA – (March 23, 2020) Diazyme announces the availability of two serological tests for the novel coronavirus (SARS-CoV-2), namely the Diazyme DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA test kits. The Diazyme IgG and IgM tests are run on the fully automated Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer. The Diazyme serological test notification is now listed on FDA’s EUA webs …