Quote:
Bio-Rad Laboratories Inc. (BIO) has started the commercial launch of its blood-based kit test which is used to screen if patients have developed antibodies against SARS-CoV-2, the virus causing COVID-19...On an update on regulatory hurdles, Bio-Rad said the company has met the CE mark requirements for Europe and has applied for Emergency Use Authorization status awarded by the U.S. Food and Drug Administration.
“Having applied for FDA Emergency Use Authorization and meeting the requirements for CE marking, we have begun shipping the test and are in the process of scaling up manufacturing to meet demand in the weeks and months ahead,” Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President said. Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 98 percent. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.
The results of the preliminary data sound actually pretty good. It would not surprise me if they aren't far off from outright FDA approval when it comes to data.