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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Core revenues were up 10 percent organically, while COVID-19 testing contributed $535 million to revenues in Q1 2021.

The firm said its rapid antigen test provided 97.3 percent sensitivity and 99.6 percent specificity in clinical studies, and it is developing a saliva-based version.

This modular system uses a high-throughput version of the company's Applied Biosystems TaqPath COVID-19 Combo Kit, which received an EUA in March 2020.

The test, which runs on Ortho's Vitros system, was first CE marked in October for use with nasopharyngeal swab specimens and certain viral transport media.

The pilot program is intended to increase consistency and predictability when determining conformity with consensus standards and test methods.