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Oxford Immunotec Files FDA Submission for TB Test Sample Prep Kit

NEW YORK – Oxford Immunotec said on Thursday that it has filed a submission to the US Food and Drug Administration for its T-Cell Select reagent kit.

If approved, the kit would enable automated sample preparation for the company's T-SPOT.TB tuberculosis screening test, and would allow the assay to be used with blood samples stored for up to 54 hours at room temperature, Oxford Immunotec said.

"Filing to the FDA for T-Cell Select approval is a critical first step to bring automation to US customers," Oxford Immunotec CEO Peter Wrighton-Smith said in a statement. "There is strong demand from our lab partners and the market to automate the T-SPOT.TB test cell separation process and this reagent kit opens the door for laboratories of varying throughput requirements."

The reagent kit is already available in Europe with CE marking.

T-SPOT.TB is an interferon-gamma release assay that detects latent tuberculosis infection. In September, the company received FDA clearance to amend the pediatric age for T-SPOT.TB to include children two years of age and older.

Earlier this week, Oxford Immunotec reported that its third quarter revenues fell 8 percent year over year as the COVID-19 pandemic affected testing volumes.