Curated News
By: NewsRamp Editorial Staff
June 24, 2025
Axim Biotech Seeks FDA CLIA Waiver for Revolutionary Dry Eye Test
TLDR
- Axim Biotechnologies seeks FDA CLIA Waiver for TearScan Lf, potentially expanding market access and commercial opportunities in the U.S. for Dry Eye Disease diagnostics.
- Axim's Pre-Sub Q with the FDA for TearScan Lf aims to streamline the CLIA Waiver process, enabling broader clinical use by ophthalmologists and optometrists.
- TearScan Lf's CLIA Waiver could revolutionize Dry Eye Disease diagnosis, offering earlier, more accessible treatment options and improving patient care quality.
- Axim Biotechnologies advances towards making TearScan Lf the first CLIA waived test for Dry Eye Disease, marking a leap in diagnostic accessibility.
Impact - Why it Matters
This development is crucial for millions suffering from Dry Eye Disease, particularly Aqueous Deficient Dry Eye, as it promises a more accurate and accessible diagnostic tool. By enabling point-of-care testing without the need for complex lab infrastructure, Axim's TearScan Lf test could significantly improve patient outcomes by facilitating timely and appropriate treatment. Furthermore, the potential CLIA waiver represents a leap forward in making advanced diagnostic technologies more widely available, underscoring the importance of innovation in healthcare accessibility.
Summary
Axim Biotechnologies, Inc., a pioneer in rapid diagnostic testing for ocular and systemic conditions, has taken a significant step towards expanding the accessibility of its TearScan Lf diagnostic test by filing a Pre-Submission with the U.S. FDA for a CLIA Waiver. This move aims to simplify the process for eye care providers to administer the test outside traditional laboratory settings, potentially revolutionizing the diagnosis and monitoring of Aqueous Deficient Dry Eye Disease (ADDE). The TearScan Lf test, already FDA 510(k)-cleared, offers a groundbreaking approach to diagnosing ADDE by measuring Lactoferrin levels in tears, which are indicative of lacrimal gland function. This innovation could significantly reduce the trial-and-error approach currently prevalent in treating Dry Eye Disease, ensuring patients receive the most effective therapies sooner.
The company's CEO, Catalina Valencia, highlighted the strategic importance of this submission, emphasizing the potential for broader clinical use and commercial adoption of their diagnostic tests. Axim Biotechnologies is not only focusing on the Lactoferrin test but is also looking forward to applying for a CLIA Waiver for its IgE test, further expanding its impact on the diagnosis of ocular conditions. With the FDA's feedback expected within 60 days, Axim is poised to conduct a comparative clinical study to support its CLIA Waiver Application, marking a pivotal moment in the company's mission to enhance eye care diagnostics. For more details, visit www.AXIMBiotech.com.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, Axim Biotech Seeks FDA CLIA Waiver for Revolutionary Dry Eye Test
