The company is currently conducting clinical studies to validate AlloSure's technology — which underlies its kidney transplant test — in lung transplant patients.
The test showed 90 percent sensitivity and 75 percent specificity in a 250-patient blinded study, even without the addition of clinical risk information.
The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.
