Test Description and clinical significance
Probes/Genes
IHC/CISH
ALK1, BCL-1, BCL-2, BCL-6, BRAF, Bob1, CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD15, CD20, CD21, CD23, CD25*, CD30, CD43, CD79a, CD138, C-MYC, EBV-LMP,
Granzyme B, ICOS*, IgA, IgG, IgG4, IgM, Kappa, Ki-67, Lambda, LEF1*, Mum1, OCT2, Pax5, Perforin, PD-1, TIA1. *: Pending
CISH: EBER, Kappa, Lambda
FISH
-Follicular Lymphoma:
BCL6 (3q27), IGH/BCL2 t(14;18)
-Mantle Cell Lymphoma
CCND1/IGH t(11;14)
-Marginal Zone / MALT Lymphoma
CEP3, CCND1/IGH t(11;14), D721/D7S486 (7p11.1-q11.1/7q31), BIRC3/MALT1 (11p22.1/18q21.3)
-Aggressive B-cell Lymphoma
BCL6 (3q27), MYC-BA (8q24), IGH/BCL2 t(14;18)
-Burkitt’s Lymphoma
IGH/MYC t(8;14), IGH-BA (14q32.2)
-CLL
CCND1/IGH (11:14), ATM/TP53 (11q22, 17p13) Di3S3i9/13q34/CEN12 (13q14.2, 13q34, 12p11.1-12q11)
Flow
-Lymphocyte Subset Panel
CD3, CD4, CD8, CD19, CD45, CD56
-Lymphoplasmacytic Lymphoma Panel (LPL)
CD3, CD4, CD5, CD8, CD10, CD19, CD20, CD23, CD27, CD28, CD38, CD45, CD56, CD79b, CD81, CD117, CD138, IgA, IgG, IgM, surface Kappa, surface Lambda, cytoplasmic Kappa, cytoplasmic Lambda
-B-ALL Add-On Panel
CD10, CD19, CD20, CD22, CD33, CD34, CD38, CD45, CD58, CD123, cIgM
-Hairy Cell Leukemia Add-On Panel
CD19, CD11c, CD25, CD45, CD103, CD123
-Follicular / Large B-Cell Lymphoma Add-On Panel
CD10, CD19, CD45, BCL2
-T/NK-Cell Lymphoma Panel
CD2, CD3, CD4, CD5, CD7, CD8, CD16, CD19, CD38, CD45, CD56, CD57, Kappa, Lambda, TCR gamma/delta
-CLL Prognostication Add-On Panel
CD5, CD19, CD45, CD52, CD49d, CD56, ZAP-70
-T-ALL Add On Panel
CD2, CD1a, CD3, CD4, CD5, CD7, CD8, CD10, CD34, CD45
Molecular
-Single Gene Tests
BRAF, MYD88, TP35
-Capillary Electrophoresis PCR
IGH, TCR - Gamma, TCR - Beta
-Immunoglobulin Heavy Chain Somatic Mutation
IgVH
-Large Panel (NGS)
ATM (exons 2-63), BTK (exons 14-16), BIRC3 (exons 6-8), CARD11 (exons 2-8), CD79B (exons 4-5), DDX3X (exons 7-9, 11, 14), FBXW7 (exons 6-9), MAPK1 (exon 7), MYD88 (exons 3-5), NOTCH1 (hotspots), PIK3CA (hotspots), IK3CD (hotspots), PTEN (hotspots), PTPN6 (hotspots), SF3B1 (hotspots), TP53 (exons 2-11), XPO (exons 12, 13, 15).
Disease:
Lymphomas
Complete Consult: Accurately curated by our expert board-certified
hematopathologists, this comprehensive offering selects medically necessary
tests—Flow, IHC, FISH, and Molecular assays—based on patient diagnosis, prior test
findings, and clinical history, ensuring thorough evaluation and consultation for complex
lymphoma cases.
Specimen Requirements
Collection:
Excisional Biopsy: 0.5 cm x 0.5 cm x 0.5 cm in RPMI (Place the Rest Immediately in Formalin)
Core Needle Biopsy: 1 Core in RPMI (Place 6-8 Cores in Formalin)
Stability:
Room temperature
Unacceptable Conditions:
"If the tissue review process shows that the tumor block has insufficient tumor area or insufficient
tumor cellularity. If there are no FFPE blocks which contain sufficient tumor tissue, then the Prosigna Assay should not be run. "
Storage & Transport
"All samples must be labeled with the patient’s name, case number and specimen type. The specimen must be accompanied by the appropriate laboratory requisition containing the following information: patient’s name, date of birth, medical record number, sample type, test requested and the name of the ordering physician. Alternatively, this information is available from the laboratory information system. > Samples may be shipped at room temperature. If exposure to elevated temperatures during shipment is a concern, cold packs may be added."
CPT(s)
*CPT coding is dependent on level of service provided
New York Approved
NO
TAT
7-10 days
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
With core values rooted in service and integrity, our leadership team sets the bar high.
We consistently strive to set the model for exactly how a reference laboratory should engage with both physicians and patients.
siParadigm is accredited by CLIA (Clinical Laboratory Improvement Amendments) and certified by CAP (College of American Pathologists).
We also hold select state licensure where required.