Axim Biotechnologies, Inc. has taken a significant step towards broadening the accessibility of its Lactoferrin diagnostic test by filing a Pre-Submission with the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) Waiver. This move is aimed at facilitating the diagnosis and monitoring of Aqueous Deficient Dry Eye Disease (ADDE) by enabling the test’s administration in non-laboratory settings.

The TearScan Lf test, already FDA 510(k)-cleared, is designed to measure Lactoferrin levels in tears, which are indicative of lacrimal gland function. Reduced Lactoferrin levels are found in 80% of ADDE patients, making this test a crucial tool for distinguishing ADDE from other forms of Dry Eye Disease and avoiding ineffective treatments. The potential CLIA Waiver would allow ophthalmologists and optometrists to administer the test without the need for CLIA certification, significantly expanding its clinical use.

The Pre-Submission process is a preliminary step that allows Axim to engage with the FDA to clarify regulatory expectations and minimize potential delays in the formal waiver application process. Following FDA feedback, the company plans to conduct a comparative clinical study to support its CLIA Waiver Application, with submission expected later this year. The FDA’s review of the application is typically completed within 90 days.

Catalina Valencia, CEO of Axim Biotechnologies, emphasized the importance of this milestone in the company’s strategy to enhance the accessibility of its diagnostic tests. The achievement of a CLIA Waiver for the Lactoferrin test, and subsequently for the IgE test, is anticipated to revolutionize the diagnosis of Dry Eye Disease and ocular allergies, offering earlier and more accessible diagnostic options. This development is expected to unlock significant commercial opportunities in the U.S. market and position TearScan Lf as a leading diagnostic tool in the Dry Eye Disease segment.

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