With Home HbA1c Testing, Industry Won’t Give Up the Ghost

With Home HbA1c Testing, Industry Won’t Give Up the Ghost

Glycated hemoglobin (HbA1c or simply A1c) is one the greatest clinical and IVD industry success stories of the past decade, but has faltered on one front - home testing or patient self-testing. A seemingly natural extension of self-monitoring of blood glucose (SMBG), the market for CLIA-waived home use HbA1c tests has struggled through significant field testing error (and lot-to-lot variation in studies), limited reimbursement coverage, and a lack of resonance with patients and clinicians. Yet, ...