Not all PCR platforms are equal. There are currently no specific requirements for molecular testing in the clinical laboratory so clinicians should consider published performance characteristics for a given PCR platform. Very strict assay performance evaluation is required for FDA/EU (CE-marked) clearance. The performance characteristics of the primary PCR platform that DDI uses (CE-marked) has been published in a peer-reviewed journal (doi:10.1111/apt.13236) and confirmed in-house. The PCR testing at Doctor’s Data has been evaluated against Illumina deep sequencing.
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What are the “requirements” for validation of molecular testing?
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