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FDA clears Trinity's Streptococcus A test:

This article was originally published in Clinica

Executive Summary

Trinity Biotech has received US FDA 510(k) marketing clearance for its Uni-Gold Strep A one-step-test for helping to diagnose Group A Streptococcus. The company, which sells the test outside the US, said the new clearance would enable it to address the $43 million US market. The worldwide market for Strep A testing is calculated at $80 million. Trinity, of Dublin, Ireland, had already received FDA clearance for an older generation of the test in 1999 (see Clinica No 851, p 16). The company told Clinica that it decided not to sell the product in the US at that time because it had improved the test very shortly after the approval and, therefore, opted to wait "until the current generation came through its R&D".

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