Axim Biotechnologies Seeks FDA CLIA Waiver for Lactoferrin Diagnostic Test

Axim Biotechnologies, Inc. has filed a Pre-Submission with the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) Waiver for its TearScan Lf diagnostic test, a move that could significantly enhance the accessibility and use of the test in diagnosing Aqueous Deficient Dry Eye Disease (ADDE). The TearScan Lf is the first FDA 510(k)-cleared point-of-care diagnostic test designed to support the diagnosis of ADDE by measuring Lactoferrin tear levels, which are reduced in 80% of patients with the condition.

The Pre-Submission process is a critical step for Axim Biotechnologies to engage with the FDA early, aiming to clarify regulatory expectations and minimize potential delays in the formal waiver application. The company anticipates FDA feedback within 60 days, after which it plans to conduct a comparative clinical study to support its CLIA Waiver Application, expected to be submitted later this year. A CLIA waiver would eliminate the need for CLIA certification, allowing ophthalmologists and optometrists to administer the test in non-laboratory settings, thereby expanding its clinical use and commercial adoption.

Catalina Valencia, CEO of Axim Biotechnologies, emphasized the importance of the Pre-Submission in the company's strategy to make its diagnostic tests more accessible to eye care providers, highlighting the potential for widespread use of the Lactoferrin test in primary eye care. The company also sees this as a stepping stone towards securing CLIA waivers for other tests, including its IgE test, which could further transform the diagnostic landscape for Dry Eye Disease and ocular allergy.