News on research and diagnostic development for pathogenic diseases.
The firm is completing a clinical study that it hopes will facilitate the launch of its AST system that provides results in four hours after a positive blood culture.
The agency confused and upset many in the healthcare community last month when it said asymptomatic patients did not need to be tested.
The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.
Visby's test is a fully integrated PCR device that detects SARS-CoV-2 RNA, while SNIBE's test comprises assays for two different antibodies against the virus.
The test, which received EUA from the US Food and Drug Administration in April, is designed to detect human IgG antibodies in serum and plasma.
