Healthcare Industry News:  dust mite 

Diagnostics Regulatory

 News Release - April 9, 2019

Bluejay Diagnostics, Inc. Announces CE Mark For Its Allereye(R) Tear Total IgE Test

The Allereye® Tear Total IgE Test is the only non-invasive, rapid, point-of-care test for allergic conjunctivitis.

ACTON, Mass., April 9, 2019 -- (Healthcare Sales & Marketing Network) -- Bluejay Diagnostics, Inc. (Bluejay) is pleased to announce that it has received CE Mark for the Allereye® Tear Total IgE Test. Allereye, an FDA-Cleared point-of-care (POC) device, offers healthcare providers a cost-effective, non-invasive, reliable, easy-to-use solution to aid in the diagnosis of allergic conjunctivitis. Bluejay expects to launch the product in Q2 of 2019 throughout Europe and the Middle East.

"We are excited to receive the CE Mark for Allereye, said Arthur L. Loomis, a Bluejay Board Member. "Such an approval will allow us to introduce a much-needed point-of-care test in the EU and the Middle-East. Every year, millions of people all over the world visit their doctors seeking relief from conjunctivitis. Until now, the diagnostic tests were highly-invasive, time-consuming and expensive. Allereye is minimally invasive, fast and cost-effective. It is simply more convenient and comfortable for patients and caregivers alike."

Allereye confirms the presence of total IgE in tears. Developed on a unique design and technology platform, Allereye offers non-invasive and rapid (15 minutes) POC detection of IgE in the aid to diagnose allergic reactions in the eye. Such detection at point-of-care might prevent unnecessary dry-eye treatment and unnecessary antibiotic regimen.

Svetlana Dey, President of Bluejay, added, "After receiving very positive feedback from U.S. clinicians and patients, we are confident that Allereye will bring the same value to the patient population throughout Europe and the Middle East."

Interest in conjunctivitis commonly known as 'red-eye' has increased in recent years due to its growing prevalence, increasing healthcare costs, and its impact on patient quality of life. Often allergic, viral, and bacterial related 'red-eye' have similar symptoms leading to an inaccurate diagnosis more than half of the time and resulting in unnecessary time away from work, school and play.

Currently about two out of every five people worldwide suffer from allergic conjunctivitis. Itchy eyes are the most common symptom. Seasonal allergic conjunctivitis is the most common form as symptoms are associated with specific aeroallergens. Perennial allergic conjunctivitis persists throughout the year and is often caused by dust mites, molds and pet dander.

About Bluejay Diagnostics, Inc.

Bluejay Diagnostics, Inc. develops, manufactures and markets easy-to-use, point-of-care medical diagnostics tests. The company offers multiple FDA-Cleared non-invasive, affordable products, including the Allereye® Tear Total IgE Test used to aid in the diagnosis of allergic conjunctivitis, and a urine-based HIV-1 screening test and a HIV-1 confirmatory test. Bluejay, headquartered in Acton, Massachusetts, continues to leverage its innovate, proprietary platform to develop new products for underserved diagnostic markets.

Any forward-looking statements are subject to risks and uncertainties. Actual results may differ materially from anticipated results.

Source: Bluejay Diagnostics

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