FAQ on Axim Biotechnologies' Pre-Submission for CLIA Waiver on Lactoferrin Diagnostic Test
Summary
Axim Biotechnologies has filed a Pre-Submission with the FDA for a CLIA Waiver on its Lactoferrin point-of-care diagnostic test, aiming to simplify and expand its use in diagnosing Aqueous Deficient Dry Eye Disease.
What is the significance of Axim Biotechnologies’ Pre-Submission to the FDA?
The Pre-Submission is the first step towards obtaining a CLIA Waiver for the Lactoferrin diagnostic test, which would allow its use in non-laboratory settings by eye care providers, significantly broadening its clinical application.
What is the TearScan Lf test used for?
TearScan Lf is a point-of-care diagnostic test intended to support the diagnosis of Aqueous Deficient Dry Eye Disease (ADDE) by measuring Lactoferrin tear levels, which are reduced in 80% of patients with ADDE.
Why is obtaining a CLIA Waiver important for Axim Biotechnologies?
A CLIA Waiver would eliminate the need for CLIA certification, enabling ophthalmologists and optometrists to administer the test in non-laboratory settings, thus facilitating broader clinical use and accelerating commercial adoption.
How does the TearScan Lf test benefit patients with Dry Eye Disease?
The test helps distinguish ADDE from other forms of Dry Eye Disease, avoiding ineffective treatments, and allows monitoring of treatment response and disease progression over time through repeated testing.
What are the next steps after the Pre-Submission?
Following FDA feedback, expected within 60 days, Axim plans to conduct a comparative clinical study to support its CLIA Waiver Application, which is anticipated to be submitted later this year.
Who is involved in the development and approval process of the TearScan Lf test?
Axim Biotechnologies is the developer, and the U.S. Food and Drug Administration (FDA) is the regulatory body involved in the approval process for the CLIA Waiver.
When is the CLIA Waiver Application expected to be submitted?
The CLIA Waiver Application is expected to be submitted later this year, after receiving FDA feedback on the Pre-Submission and completing a comparative clinical study.
What are the commercial implications of securing a CLIA Waiver for Axim Biotechnologies?
Securing a CLIA Waiver would unlock significant commercial opportunities in the U.S. market by enabling earlier, more accessible diagnosis of Dry Eye Disease, including ADDE and ocular allergy, and positioning TearScan Lf to capture market share in the diagnostic device segment for Dry Eye.
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