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. The test, which is already FDA 510(k)-cleared, measures lactoferrin levels in tears to diagnose Aqueous Deficient Dry Eye Disease (ADDE), a condition where lactoferrin is reduced in approximately 80% of patients. The pursuit of a CLIA waiver aims to eliminate the requirement for CLIA certification, enabling ophthalmologists and optometrists to use the test in non-laboratory settings such as clinics or offices.
This regulatory step could significantly enhance the test's clinical utility and commercial adoption by making it more accessible to eye care providers without the need for complex laboratory infrastructure. Following the FDA's feedback, which is expected within 60 days, Axim plans to conduct a comparative clinical study to support its CLIA Waiver Application, with submission anticipated later this year. The FDA's review process for such applications typically takes about 90 days. Achieving a CLIA waiver would mark a pivotal advancement in the diagnosis and treatment monitoring of ADDE, offering a more straightforward approach for healthcare providers to implement in routine practice.
Catalina Valencia, CEO of Axim Biotechnologies, emphasized the company's commitment to facilitating easier integration of their tests into clinical practices, highlighting the potential for widespread use of the TearScan Lf test in primary eye care and beyond. The company also anticipates that securing CLIA waivers for its diagnostic tests will unlock significant commercial opportunities in the U.S. market. For more information on Axim Biotechnologies, visit https://www.aximbiotech.com. The implications of this move extend beyond regulatory approval, as it could streamline patient care by allowing faster, on-site diagnosis, potentially improving treatment outcomes and expanding market reach for Axim's innovative diagnostic solutions.
