OVERVIEW
AXIM is developing specialized point-of-care diagnostic assays designed to detect and assess key tear biomarkers associated with ocular surface disease and to provide objective data to aid in clinical decision-making.
The Company is currently preparing a 510(k) submission to seek FDA clearance to commercialize its updated Lactoferrin diagnostic device and intends to submit a subsequent 510(k) application for its updated IgE diagnostic test.
These products are under development and have not yet received clearance from the U.S. Food and Drug Administration.
BACKGROUND
According to the American Academy of Ophthalmology, approximately 20 million people in the United States (344 million people worldwide) have Dry Eye Disease, and that number is growing in both young and old adults, making it imperative that clinicians figure out how best to diagnose and treat it. According to the American Journal of Ophthalmology, as of July, 2017, a study reported an estimated 6 million people reported having experienced Dry Eye Disease symptoms but had never been diagnosed.
Diagnosing Dry Eye Disease is a challenge because it’s a multifactorial disease, with many disparate causes. It has a highly variable symptom profile at different stages of the disease, and there’s often a discordance between signs and symptoms.
CLINICAL NEED FOR POINT OF CARE TESTING
– Able to obtain rapid test results
– Patients prefer lab testing
– Improved patient care
– Treatment and duration of treatment chosen specifically for patient test result
– Very accurate, objective, differential diagnosis
POINT-OF-CARE SOLUTION
AXIM is developing a Point-of-Care lateral flow diagnostic assay tests for levels of Lactoferrin through the collection of tears. Lactoferrin is a protein contained in tears, which protects the ocular surface with its antimicrobial and anti-inflammatory properties. Lower concentrations of lactoferrin have been demonstrated in patients with Dry Eye, which is associated with decreased aqueous tear production.
AXIM is currently preparing a 510(k) submission to seek FDA clearance to commercialize its updated Lactoferrin diagnostic device and intends to submit a subsequent 510(k) application for its updated IgE diagnostic test.
These products are under development and have not yet received clearance from the U.S. Food and Drug Administration.