Axim Biotechnologies has entered a binding term sheet with Advanced Tear Diagnostics to acquire the technology for dry eye disease (DED) testing.
Through the acquisition, AXIM will gain access to two US Food and Drug Administration (FDA)-cleared ophthalmic diagnostic lab tests.
These tests are part of a point-of-care (POC) laboratory testing system created to aid eye-care physicians in identifying and measuring various biomarkers linked to external ocular disorders.
Both tests are approved for reimbursement, the company noted.
The first test is a rapid POC lateral flow diagnostic assay with a reader that detects the precise Lactoferrin levels from 0.5μl of tears in ten minutes.
A protein found in tears, Lactoferrin shields the ocular surface due to its antimicrobial and anti-inflammatory properties.
AXIM noted that reduced levels of Lactoferrin were seen in dry eye patients, which is related to low aqueous tear generation.
Another test being acquired measures the ocular Immunoglobulin E (IgE), which is a biomarker for allergies and a vital biomarker involved in DED.
With the increased clinical utility, this test can be used to confirm the presence of an active ocular allergen and uses the same reader system.
AXIM’s scientific team is streamlining the assay with plans to launch it in the market in the first quarter of next year.
AXIM Biotechnologies CEO John Huemoeller II said: “For years, doctors have had to rely on patient symptoms and subjective evaluation of clinical signs to diagnose dry eye disease.
“The tests we are acquiring are specifically differential for a diagnosis of dry eye disease and also provide a quantitative measure for the doctor to assess the severity of the condition.”
AXIM and Advanced Tear Diagnostics plan to sign a definitive agreement for the deal scheduled to conclude by 1 October 2021.
Apart from the FDA-approved assays, AXIM expects to create diagnostic tests for Matrix metalloproteinase 9, ocular adenovirus, ocular osmolarity, ocular herpes, trachoma, bacterial-viral differentiation, glucose and breast cancer screening among others.