Test Classification Current Value

Progentec Diagnostics testing uses an immunoassay to measure the concentrations of plasma proteins. Progentec Diagnostics developed and characterized this test. It is intended for clinical use and the reported results should be interpreted in relation to each patient's clinical condition and medical history. This test is a laboratory developed test (LDT) and is not cleared by the US Food and Drug Administration (FDA). FDA clearance is not currently required for LDTs. Progentec Diagnostics Clinical Laboratory is certified under the Clinical Laboratory Improvement Amendment (CLIA) of 1988 and accredited by the College of American Pathologists to perform high complexity clinical testing.

Test Classification Value Prior to 6/24/2026 10:07am

This test was developed and its performance characteristics determined by Progentec Diagnostics. It has not been cleared by the US Food and Drug Administration (FDA). This test was performed in a CLIA certified laboratory and is intended for clinical purposes.