Bluejay Diagnostics has entered a clinical research agreement with Hitachi Chemical to create a noninvasive, point-of-care test that detects the antibody immunoglobulin E (IgE) in tears. The resulting technology could potentially be used to diagnose allergic conjunctivitis.
According to the CDC, a physician can usually determine if conjunctivitis is caused by a bacterium, virus or allergen by examining the eye and considering symptoms and patient history. But because symptoms may be the same across the different types of conjunctivitis, it can be challenging to make a firm diagnosis. Lab testing to diagnose conjunctivitis is not routinely done, the CDC said.
Under the agreement, Acton, Massachusetts-based Bluejay will gain access to Hitachi’s Allerwatch device, which is already marketed in Japan for the diagnosis of allergic conjunctivitis, the pair said in a statement. Bluejay will have exclusive development, marketing and manufacturing rights to the technology in the Americas and Europe.
"Strengthening the allergy business is part of Hitachi Chemical's in vitro Diagnostics strategy. Our collaboration in developing a point of care total tear IgE test with Bluejay and expansion into non-invasive in vitro diagnostics is right in line with this strategy," said Tsuyoshi Uchida, director of Hitachi Chemical’s medical business unit, in the statement. "With the tear IgE test in the US market, it will complement our flagship Optigen (allergen-specific IgE assay) product line and expand our US allergy business."
Bluejay’s flagship product, a point-of-care test for allergic conjunctivitis is currently in 510(k) clinical trials, according to the statement. The company expects to launch the test later this year.
"Our collaboration with Hitachi Chemical in developing a total tear IgE non-invasive test complements Bluejay's research and development strategy of tailored point-of-care diagnostics, or in other words, finding the right material and technology at the right time for patients,” said Bluejay CEO Svetlana Dey, in the statement. “Through our collaboration with Hitachi Chemical, we hope to deliver non-invasive, rapid, point-of-care tests that enhance patient care and just as importantly avoid unnecessary treatment regimens, such as antibiotics."