The MolDX^® Program is a Medicare supported initiative administered by Palmetto GBA. It includes a rigorous evaluation of molecular testing to ensure that only clinically useful, analytically valid, and medically necessary molecular diagnostic tests are paid for by Medicare.^{1, 2}

*The MolDX^® initiative evaluates molecular diagnostic tests for Medicare coverage.

1.Palmetto GBA. Molecular Diagnostic Tests and Medicare – MolDX. Accessed June 10, 2025. https://palmettogba.com/palmetto/moldxv2.nsf/DID/DPR6GEM991
2. Revenulytics. Understanding the MolDx Program: An Essential Guide. Accessed June 10, 2025. https://www.revenulytics.com/blogs/understanding-the-moldx-program-an-essential-guide

Onycho·ID^™ is the first and only PCR-based Onychomycosis test with MolDX^® approval — providing an unmatched approach for identifying the infectious agent. It delivers accurate, pathogen-specific data to guide targeted therapy, enhancing therapeutic efficacy.

Accurate diagnosis:

• Only 50% of suspected cases of onychodystrophy are onychomycosis.³
• Potential therapeutic differences require the identification of NDMs and mixed infections.
• Laboratory confirmation is essential to guide clinical therapeutic decision-making.

Antifungal Stewardship:

• Supports targeted therapy by confirming fungal etiology prior to treatment.
• Ensures appropriate systemic antifungal utilization, reducing risk of side effects—especially in elderly or individuals with underlying conditions.
• Promotes responsible prescribing practices aligned with antifungal stewardship initiatives.

Scientific Evidence:

• The CDC and AAD recommend confirmatory testing prior to the initiation of antifungal therapy.
• Aligns with evidence-based medicine for accurate diagnosis and optimal treatment planning.

3. Gupta AK, et al. J Fungi. 2023;9(6):671

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