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Axis-Shield's Afinion albumin/creatinine ratio diabetes test

This article was originally published in Clinica

Executive Summary

Axis-Shield's Afinion ACR test for diabetes patients will soon hit the US market, after gaining 510(k) clearance from the FDA. The test measures the albumin/creatinine ratio (ACR) in urine - a measure of kidney function and cardiovascular complication that may occur in patients with poorly controlled diabetes. The Norwegian/Scottish company said that the test will complement its CLIA-waived Afinion Hb1Ac assay, which is used for monitoring diabetes treatments. The test will be marketed and sold by Axis-Shield's distribution partner Abbott Laboratories.

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