EYE DIAGNOSTICS
OVERVIEW
AXIM Eye has developed and commercialized two highly specialized Point-of-Care (POC) diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis.
Additionally, AXIM is in the development of a quantitative tear MMP-9 test is a significant advance to measure the intensity of inflammation affecting dry eye patients allowing for more objective classification the disease. The clinical benefits of the quantitative test for MMP-9 as a tool for accurate diagnosis of Dry Eye Disease and subsequent treatment include more accurate pre-surgical and post-surgical outcomes. Post-surgical complications, such as corneal wound healing, is facilitated by identifying dry eye prior to surgery.
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
– Reduces physician chair time
– Able to obtain rapid test results
– Patients prefer lab testing
– Improved patient care
– Treatment chosen specifically for patient test result
– Reimbursable through CMS and private insurance
– Very accurate, objective, differential diagnosis
– No out-of-pocket cost to patients
– New tests are being developed every day due to ongoing need for solutions
our tests
The first is a rapid Point-of-Care (8 minute) lateral flow diagnostic assay paired with a reader that tests for exact levels of Lactoferrin through the collection of 0.5 microliter in tears.
The second is designed for the measurement of Ocular Immunoglobulin E (IgE), a key biomarker primarily associated with non-specific, allergic conjunctivitis which often mimics DED and can manifest with DED.
Both tests are FDA-cleared and CMS and insurance reimbursable and are available now through commercialization partner Verséa Ophthalmics
IgE
This test is designed for the measurement of Ocular Immunoglobulin E (IgE), a key biomarker primarily associated with non-specific, allergic conjunctivitis which often mimics DED.
Lactoferrin
This is a rapid Point-of-Care (8 minute) lateral flow diagnostic assay paired with a reader that tests for exact levels of Lactoferrin through the collection of 0.5 microliter of tears.