NicOx has entered into an exclusive agreement with Immco Diagnostics to promote a proprietary laboratory test targeted at early detection and diagnosis of SjÃ¶gren's syndrome to eye care professionals in North America. The collaboration will give eye care practitioners and their patients' increased access to this test that supports early diagnosis and potentially more efficient management of this chronic disease.
Under the terms of the agreement, Immco will grant NicOx the exclusive rights to promote the laboratory test to eye care practitioners in North America (US, Canada, Puerto Rico and Mexico). NicOx will be responsible for all marketing activities, while Immco will carry out the test in its CLIA-approved laboratory in Buffalo, NY, and be responsible for regulatory activities and reimbursement. NicOx will receive a majority share of revenue generated from eye care practitioners and no upfront or milestones payments will be made by NicOx. NicOx also has a nine month option to negotiate an agreement to promote the test in the rest of the world. During this period, both the companies will plan to study and evaluate the feasibility and implementation steps for the test in other markets, including Europe.
Current diagnostic methods for SjÃ¶gren's syndrome are only moderately effective at diagnosing the disease and can be used only once it has progressed to an advanced stage where treatment options are limited. The laboratory test developed by Immco is a highly sensitive and specific diagnostic test combining three novel proprietary biomarkers: SP-1(salivary gland protein-1), CA-6 (carbonic anhydrase-6) and PSP (parotid secretory protein); and the traditional markers (ANA, Ro, La, RF). During studies, these novel antibodies were found in 45 per cent of patients meeting the criteria for SjÃ¶gren's syndrome who lacked the traditional antibodies for Ro or La. In patients diagnosed with idiopathic xerostomia and xerophthalmia for less than two years, 76 per cent had antibodies to SP-1 and/or CA-6 while only 31 per cent had antibodies to Ro or La.
This breakthrough test can aid in diagnosing SjÃ¶gren's syndrome at an earlier stage compared with traditional methods therefore significantly improving management of the disease. The test was approved by the appropriate regulatory authority in the US in 2013, and is already available to doctors across North America.