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Oxford Immunotec Gets China FDA Approval for TB Reagent Kit

NEW YORK (360Dx) – Oxford Immunotec Global today announced regulatory acceptance by the China Food and Drug Administration of T-Cell Select, an immune cell separation reagent kit designed to simplify workflow, improve throughput, and reduce hands-on time and labor costs in performing the T-Spot.TB test.

Using the kit, laboratorians can store blood samples collected in a single standard blood tube for up to 54 hours at room temperature before use, which provides advantages associated with simplicity and logistics to customers, Oxford Immunotec said.

The Oxford, UK-based firm noted that its T-Spot.TB test has been approved for sale in more than 50 countries, including America, where it has received pre-market approval from the US Food and Drug Administration; Europe, where it has obtained a CE mark; and Japan as well as China.

In September, Quest Diagnostics announced it was acquiring the US laboratory testing business of Oxford Immunotec for $170 million in cash. The acquisition includes T-Spot.TB and the Accutix tick-borne disease testing service provided by Oxford Immunotec's labs in Norwood, Massachusetts and in Memphis, Tennessee. 

In Friday morning trade on the Nasdaq, shares of Oxford Immunotec were up a fraction of a percent at $15.05.