Axim Biotechnologies Files Pre-Submission With FDA For CLIA Waiver Pathway On Lactoferrin Point-Of-Care Diagnostic Test

Axim Biotechnologies, Inc. a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has filed a Pre-Submission (Pre-Sub Q) with the U.S. Food and Drug Administration (FDA) as the first formal step in seeking a Clinical Laboratory Improvement Amendments (CLIA) Waiver for its rapid, point-of-care Lactoferrin diagnostic test (TearScan Lf).

Axim’s TearScan Lf is the first and only FDA 510 (k)-cleared point-of-care (POC) diagnostic test specifically intended to support the diagnosis of Aqueous Deficient Dry Eye Disease (ADDE). Lactoferrin tear levels are a convenient POC diagnostic that aids in determining the viability of the lacrimal gland. Lactoferrin levels are reduced in 80% of patients with ADDE. By distinguishing ADDE from other forms of Dry Eye Disease, the test helps avoid trial-and-error use of therapies that are ineffective for tear deficiency. Additionally, because Lactoferrin levels reflect lacrimal gland function, repeated testing allows the physician to monitor response to treatment and disease progression over time.

The Pre-Sub Q process allows device developers to engage early with the FDA to receive feedback, clarify regulatory expectations, and minimize risks of delays during the formal waiver application. FDA feedback is anticipated within 60 days. Upon FDA feedback, the company plans to conduct a comparative clinical study to support its CLIA Waiver Application, which is expected to be submitted later this year. The FDA typically completes review of CLIA Waiver Applications within 90 days.

Currently, facilities must obtain CLIA certification and adhere to laboratory protocols in order to administer Axim’s Lactoferrin test. A CLIA waiver would eliminate the certification requirement and enable administration of the point-of-care Lactoferrin test by ophthalmologists and optometrists in non-laboratory settings thereby allowing for far broader clinical use and accelerating commercial adoption.

“The Company’s Pre-Sub Q submission marks a significant milestone in its strategy to broaden access to its tests by obtaining a CLIA waiver. We are committed to making it easier for eye care providers to integrate our tests into their practices without complex lab infrastructure,” said Catalina Valencia, CEO of Axim Biotechnologies. “Today’s submission is the first step in that process, and we believe it will open the door to widespread use of our Lactoferrin test—and soon after, our IgE test—in primary eye care and beyond. We believe that securing CLIA waivers for our Lactoferrin and IgE tests will be transformative, unlocking significant commercial opportunities in the U.S. market and enabling earlier, more accessible diagnosis of Dry Eye Disease, including ADDE and ocular allergy. As a CLIA waived, semi‑quantitative, point-of-care biomarker test, TearScan Lf would be well-positioned to capture market share in the diagnostic device segment for Dry Eye.”

About AXIM Biotechnologies
Founded in 2014, AXIM Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dry Eye Disease. For more information, visit www.AXIMBiotech.com.