Pfizer - Patient Genotypes

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Three Screening Tests to Rule Out AL Amyloidosis^1-3

Transthyretin Amyloid Cardiomyopathy > Diagnosis of ATTR-CM > Ruling Out Light-Chain Amyloidosis > Screening Test

DISTINCTION BETWEEN ATTR-CM and AL IS CRITICAL

SERUM FREE
LIGHT-CHAIN ASSAY

SERUM PROTEIN
ELECTROPHORESIS WITH
IMMUNOFIXATION

URINE PROTEIN
ELECTROPHORESIS WITH
IMMUNOFIXATION

Abnormal if serum kappa or lambda
free light-chain are elevated, or if
kappa/lambda ratio is <0.26 or >1.65^1,2

Abnormal if monoclonal protein
is detected (M-spike present)^1,2

Refer to hematologist if one or more abnormal or if there is any diagnostic uncertainty¹

The National Comprehensive Cancer Network (NCCN) guidelines recommend protein electrophoresis, immunofixation, and serum free light chain assays in the initial diagnostic workup of AL amyloidosis³

	n	All the 5 tests	Serum PEL and IFE; urine IFE	Serum PEL, IFE, and FCL	Serum PEL and FLC	Serum IFE	Serum PEL	Serum FLC

Diagnosis, n
All	1877	1851	1821	1828	1770	1632	1482	1395
MM	467	467	461	467	467	441	409	452
Macroglobulinemia	26	26	26	26	26	26	26	19
SMM	191	191	191	191	190	188	180	155
MGUS	524	524	524	509	465	468	429	222
Plasmacytoma	29	26	26	26	25	21	21	16
POEMS	31	30	30	30	23	30	23	3
Extramedullary plasmacytoma	10	2	2	1	1	1	1	1
Primary AL	581	570	547	564	559	429	382	513
LCDD	18	15	14	14	14	10	10	14
Diagnosis, %
All		98.6	97.0	97.4	94.3	87.0	79.0	74.3
MM		100.0	98.7	100.0	100.0	94.4	87.6	96.8
Macroglobulinemia		100.0	100.0	100.0	100.0	100.0	100.0	73.1
SMM		100.0	100.0	100.0	99.5	98.4	94.2	81.2
MGUS		100.0	100.0	97.1	88.7	92.8	81.9	42.2
Plasmacytoma		89.7	89.7	89.7	88.2	72.4	72.4	55.2
POEMS		96.8	96.8	96.8	74.2	96.8	74.2	9.7
Extramedullary plasmacytoma		70.0	20.0	10.0	10.0	10.0	10.0	10.0
Primary AL		98.1	94.2	97.1	96.2	73.8	65.9	88.3
LCDD		83.3	77.8	77.8	77.8	55.6	55.6	77.8

Three Screening Tests to Rule Out AL Amyloidosis1-3

Sensitivity of Monoclonal Gammopathy Screening Panels

Three Screening Tests to Rule Out AL Amyloidosis^1-3