Rythm and Theranos are fundamentally different because our core technology, laboratory practices, and approaches to testing and validation are entirely different. Rythm uses an FDA-cleared blood collection device, Tasso+, to collect a standard capillary specimen into the same Microtainer tubes used throughout traditional healthcare. The sample is then tested in Rythm’s own CLIA-certified, CAP-accredited laboratory using FDA-regulated analyzers and validated clinical assays, with the collection method supported by published, peer-reviewed evidence.

This is fundamentally different from what Theranos claimed. Theranos was developing a new laboratory testing instrument, claiming its proprietary technology could perform hundreds of tests using tiny blood volumes. Those instruments were not broadly FDA-cleared for the clinical claims being made, and the technology was never demonstrated to be reliably comparable to established laboratory methods.