Regulatory & accreditation standards. CRL operates as a CLIA-certified (CLIA #10D2331536) and COLA-accredited (#34996) clinical laboratory under the oversight of a physician Lab Director, Dr. Rodrigo M. Murillo-Alvarez, M.D. Reporting follows HIPAA privacy standards, and results are issued as formal final reports intended for interpretation by a licensed healthcare professional.

Testing methodology. CRL’s core methodology is targeted PCR (polymerase chain reaction) molecular diagnostics. The assays are laboratory-developed tests (LDTs) whose performance characteristics were developed and validated in-house by the lab; they are not FDA-approved, which the FDA has determined is not required for this category. Each assay works by identifying proprietary, species-specific targeted amplicons—meaning it detects the unique genetic signature of each pathogen and antibiotic-resistance gene on the panel. Results are reported semi-quantitatively (estimated CFU/mL), derived from the lab’s internal validation studies and the scientific literature, which CRL notes can more accurately reflect true pathogen concentration than agar-based culture because of PCR’s higher sensitivity.