Quidel Corp. (Nasdaq: QDEL), a San Diego-based provider of rapid diagnostic testing solutions, reports it has received clearance from the Food and Drug Administration (FDA) to market its Lyra Direct Strep Assay.
This new molecular test detects and differentiates between pyogenic Group A and pyogenic C or G Streptococcal throat infections.
The assay kit includes an extraction-free, three-step sample preparation process that does not require automated extraction. This fast and easy direct-to-amplification procedure allows the assay to generate a result in just over an hour.
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