Dean’s Chat Learning Series hosts, Drs. Jensen and Richey, sit down with Dr. Warren Joseph, to discuss fungal infections and antifungal resistance.
Below are some takeaway notes:
1. Onycho.ID is the first and only Medicare (MolDx) approved, laboratory PCR test for the diagnosis on onychomycosis, developed and clinical validated by BakoDx
2. Why choose Onycho.iD? Because it provides an unmatched approach for identifying the infectious agent a. Sensitivity: 92.6% Specificity: 100% (vs histopathology) b. Supports data-driven treatment decisions and improved patient outcomes c. 24-48 turn-around-time d. Detection of dermatophytes, non-dermatophytes, molds and yeasts e. Cost-effective and eliminates unnecessary additional testing
3. Identify Terbinafine Resistance using PCR Assay a. Trichophyton rubrum and Trichophyton mentagrophytes represents 59% of the organisms responsible for nail infections b. Terbinafine is the most common prescribed medication c. Terbinafine resistance is on the rise d. PCR testing (Onycho.ID) provides novel and specific real-time TaqMan PCR testing to detect 12 mutations of T. rubrum and T. mentorophytes
What is MolDx? The MolDX (Molecular Diagnostic Services) Program is a Palmetto GBA-managed Medicare program that evaluates, registers, and determines coverage/reimbursement for molecular diagnostic tests.
It ensures tests are clinically valid, assigns unique DEX Z-Codes for identification, and sets policies for over 28 states to ensure Medicare covers only medically necessary, evidence-based tests. MolDX States (Strict Molecular Testing Review)
These states follow the MolDX Program run by Palmetto GBA, which requires DEX Z-codes and technical assessment for PCR tests.
Southeast • Alabama • Georgia • Tennessee • North Carolina • South Carolina • Virginia • West Virginia Midwest • Indiana • Michigan • Iowa • Kansas • Missouri • Nebraska • Kentucky • Ohio Western States • California • Arizona • Nevada • Utah • Oregon • Washington • Idaho • Montana • Wyoming • North Dakota • South Dakota • Alaska • Hawaii
Additional comments from Dr. Scherer, Bako Consultant – who will be joining us on a future episode: “The main benefit of Bako Diagnostics’ screening and reflex PCR testing for nails is that it provides a very cost-effective method for PCR analysis. With this approach, the laboratory first performs a screening test. If a dermatophyte is detected during screening, only four PCR probes (cycles) are run in the reflex test, and the test is billed only for those probes. However, if a different type of fungus is identified during screening, the reflex test expands accordingly. For example, if a non-dermatophyte mold is suspected, the lab tests for seven different organisms. Similarly, if yeast is indicated, the reflex panel focuses on yeast organisms. The advantage of this screening-and-reflex algorithm is that the laboratory limits the number of DNA probes used to only the genus or group identified in the initial screening. This targeted approach reduces unnecessary testing and ultimately produces the lowest possible cost for PCR toenail diagnostics.”