Nicox recently announced that it has partnered with Immco Diagnostics to promote a proprietary laboratory test for early detection of Sjögren’s syndrome. The unnamed test was approved in the U.S. this year and will be launched this fall.
Under the terms of the agreement, Immco will grant Nicox the exclusive rights to market the test to eyecare practitioners in North America. Nicox will be responsible for all marketing activity; Immco will carry out testing in its CLIA-approved laboratory in Buffalo, NY, and handle regulatory activity and reimbursement.
This test, which has yet to be named, combines three proprietary biomarkers (salivary gland protein-1 [SP-1], carbonic anhydrase-6 [CA-6], and parotid secretory protein [PSP]) with traditional markers (antinuclear antibodies [ANA], Ro, La, and Rf [rheumatoid factor]). The proprietary markers were recently discovered by researchers at the University of Buffalo and Immco Diagnostics.1 Traditional tests for the disease use ANA, Ro, La, and Rf antibodies, which exhibit sensitivity limitations or are associated with later-stage Sjögren’s syndrome, according to Nicox. The newer antibodies were found in 45% of patients meeting the criteria for Sjögren’s syndrome, but lacking antibodies for Ro and La. In patients diagnosed with xerostomia for less than 2 years, 76% had antibodies to SP-1 or CA-6, while only 31% had antibodies to Ro or La.1
The test will not require a Clinical Laboratory Improvements Amendments (CLIA) waiver. “The practitioner will be able to write the order for the patient to go to a local lab,” says Nicox Director of Marketing Jason Menzo. “Forty-eight hours later, the practitioner will receive the results. Alternatively, the practitioner may use a lancet to take a sample, then overnight the sample to the Immco laboratory to avoid sending the patient out.”
“The availability of this new diagnostic will further empower optometrists to better fulfill their role as primary eyecare doctors by broadening their diagnostic expertise beyond the exam room,” says Optometry Times Associate Optometric Editor Katherine M. Mastrota, OD, FAAO, in New York City. “It is of enormous potential to any eyecare professional, particularly those interested in dry eye and ocular surface disease. It would not be surprising that screening for Sjögren’s becomes as routine as is a visual field for glaucoma as a component of the comprehensive eye exam.”
Says Art Epstein, OD, FAAO: “The thinking currently is that 10% of the population, maybe more, has preclinical Sjögren’s syndrome. This new laboratory test gives practitioners the ability to examine each patient and find specific markers for Sjögren’s. It will provide another piece of information to help manage these patients to prevent them from spiraling downward, as many seem to do. A practitioner can interface much more effectively with a rheumatologist or internist early on to have these patients monitored and treated.” Dr. Epstein is a consultant for Nicox and is in practice in Phoenix.ODT