Every assay is validated to established performance standards before clinical use, and all testing runs under a quality management system with layered oversight — specimen integrity checks, batch quality controls, routine calibration, external proficiency testing, and result review. Performance characteristics like sensitivity and specificity vary by assay, so we provide detailed performance data for individual tests upon request rather than a single portfolio-wide figure.

Our tests are laboratory-developed tests (LDTs), validated in-house under CLIA regulations governing high-complexity clinical laboratories. LDTs are not subject to FDA premarket approval. Validation data is available on request.

SoftCell bills most major insurance plans directly, including Medicare. Coverage and patient responsibility vary by plan and by test. For practices: we bill the payer directly, so your office is not invoiced for insured patients. To have coverage checked for a specific test or plan before you order, call (503) 402-2505.