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Bluejay Diagnostics Gets CE Mark for Allergic Conjunctivitis Test

NEW YORK (360Dx) — Bluejay Diagnostics said today that it has received a CE mark for its Allereye Tear Total IgE point-of-care test for the diagnosis of allergic conjunctivitis.

Allereye comprises a reagent-ready test strip that measures the presence of human immunoglobulin E (IgE) in a tear sample within 10 minutes. Acton, Massachusetts-based Bluejay said it expects to launch the test in Europe and the Middle East in the second quarter.

"After receiving very positive feedback from US clinicians and patients, we are confident that Allereye will bring the same value to the patient population throughout Europe and the Middle East," Bluejay President Svetlana Dey said in a statement.

The test is cleared by the US Food and Drug Administration, but not yet available for sale in the US.

In 2017, Bluejay partnered with Hitachi Chemical to develop Allereye.

Earlier this month, the firm signed an agreement with the US Naval Medical Research Center to develop a non-invasive point-of-care test for early-stage detection of Lyme disease.