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If approved, the kit would enable automated sample preparation for the company's T-SPOT.TB test using blood samples stored up to 54 hours at room temperature.
The firm's revenues in Asia were up compared to a year ago, but the coronavirus pandemic drove down revenues in the US, Europe, and the rest of the world.
News items for the in vitro diagnostic industry for the week of Oct. 19, 2020.
Fujirebio Diagnostics got the nod for a chemiluminescent enzyme immunoassay to measure levels of CA 15-3 and manage patients diagnosed with breast cancer.
Of the 32 companies in the index, 21 firms saw their stock prices increase, while 11 firms' share prices decreased.
The single-visit blood test is one of two FDA-cleared alternatives to the traditional tuberculin skin test, according to Oxford Immunotec.
A Public Health England study could help facilitate regulatory submissions for Oxford Immunotec's test to measure T cells and the immune response to SARS-CoV-2.
A number of research groups and companies are exploring use of T-cell response testing in areas like vaccine development and assessing spread of the virus.
Oxford Immunotec said that a decrease in revenues for its US business was partly driven by the impact of planned inventory destocking by Quest Diagnostics.
National TB control programs may now order the T-spot.TB, a blood test for TB screening, through the Stop TB Partnership - GDF procurement mechanism.