September 04, 2008
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1 27027 Tourney Road Valencia, CA Test Updates September 04, 2008 Dear Valued Client: As you may be aware, in recent years there has been a tremendous challenge in our industry to retain trained cytogenetic staff to meet with the testing demand in this growing specialty. Your facility may have experienced delays in turnaround time, in part due to fluctuating staff levels at Specialty or other laboratories. While Specialty has been fortunate in recent months to have full staffing, we have determined that a new approach to our cytogenetic test offering will ensure a more stable and reliable delivery of test performance. Effective November 4, 2008, Specialty will combine its resources with those of our two closest affiliated laboratories. This aggregation will mean that staff from three laboratories will coalesce to provide an enhanced service level. Additional staffing will join our Valencia facility to provide the diagnostic portion of the testing process and the preanalytical procedures will be performed in the San Juan Capistrano facility. We believe this merger of resources will provide you with quality testing, uninterrupted service levels and better turn around time. In order to facilitate these changes, we will need to create new test codes for our offerings. Please see the listing below for current offerings and the replacement codes that will be in effect. If you currently order these tests, please make the appropriate changes to your Laboratory Information Systems. Thank you for choosing Specialty and we look forward to your continued support. For additional information, please visit our Web site at or contact Client Relations at Christopher Lockhart, M.D. Laboratory Director 1 of 5
2 Affected Tests: Effective November 4, 2008: 5880 Acute Lymphoblastic Leukemia by FISH Replacement: S FISH, ALL, Pre-B Panel 5874 Acute Myeloid Leukemia/High Grade Myelodysplasia by FISH Replacement: S51714 FISH, MDS/Myeloid Panel, -5/5q-, -7/7q-, +8,20q 5840 Acute Promyelocytic Leukemia t(15;17) [FISH] Replacement: S FISH, AML M3, PML/RARA, Translocation 15, Amniocyte Culture Replacement: S Cell Culture for Possible Additional Prenatal Studies 5834 bcr/abl1 Gene Rearrangement (Philadelphia Chromosome) [FISH] Replacement: S FISH, CML/ALL, bcr/abl Translocation 9, Burkitt Lymphoma t(8;14) by FISH Replacement: S51710 FISH, Burkitts/NHL/ALL, IGH/MYC, t(8;14) 5822 Chromosome Analysis Amniotic Fluid Replacement: S Chromosome Analysis, Amniotic Fluid 5818 Chromosome Analysis: Products of Conception/Skin Biopsies Replacement: S Chromosome Analysis, Tissue 5860 Chronic Lymphocytic Leukemia (CLL) by FISH Replacement: S51705 FISH, B-Cell Chronic Lymphocytic Leukemia (B-CLL) Panel 5862 Chronic Myelogenous Leukemia (CML) by FISH Replacement: S FISH, CML/ALL, bcr/abl Translocation 9, Cytogenetics inv(16) [FISH] Replacement: S51685 FISH, AML, CBFB/MYH11, Inversion Cytogenetics MLL(11q23) [FISH] Replacement: S51715 FISH, MLL (11q23) Gene Rearrangement 5850 Cytogenetics t(8;21) [FISH] Replacement: S51682 FISH, AML, AML1/ETO Translocation 8, Cytogenetics Congenital Disorders Replacement: S51689 Chromosome Analysis, Blood 5800 Cytogenetics Hematologic & Neoplastic Disorders Replacement: S51690 Chromosome Analysis, Hematologic Malignancy 5825 Cytogenetics Solid Tumors Replacement: S51691 Chromosome Analysis, Solid Tumor 2 of 5
3 5884 del(4)(q12) by FISH (FIP1L1-PDGFRA) Fibroblast Culture Replacement: S51683 Cell Culture for Possible Additional Prenatal Studies 5843 FISH Subtelomere Abnormalities [Totelvysion] Replacement: S51684 FISH, Subtelomere Screen 5892 FISH ALK 2p23 Replacement: S51706 FISH, ALCL, ALK, 2p23 Rearrangements 5894 FISH BCL6 3q FISH C-MYC 8q24 Replacement: S51704 FISH, ALL/NHL, MYC-BA, 8q24 Rearrangement 5898 FISH Chromosome 1 Aneuploidy 5858 FISH Chromosome 18 Aneuploidy 5856 FISH Chromosome 7 Aneuploidy 5896 FISH del(13)(q14.3)d13s FISH-20q12 D20S108 Replacement: S51681 FISH, Chromosome 20q Deletion 5863 FISH-IGH 14q32 Replacement: S51709 FISH, B-Cell Malignancy, IGH, 14q32 Rearrangement 5865 FISH-MALT1 18q21 Replacement: S51717 FISH, MALT Lymphoma, MALT1, 18q21 Rearrangement 5861 FISH-p53 17p FISH-RB1 13q FISH-Trisomy 13, 18, 21, X & Y [Aneuvysion] (Prenatal) Replacement: S51692 FISH, Prenatal Screen 3 of 5
4 5887 FISH-Trisomy Follicular Lymphoma t(14;18) by FISH Replacement: S51708 FISH, Follicular Lymphoma, IGH/BCL2, t(14;18) 5830 Genetic Diseases [FISH] Replacements: S51697 FISH, Angelman S51698 FISH, Cri du chat S51699 FISH, DiGeorge, Velocardiofacial (VCFS) S51700 FISH, Miller-Dieker S51701 FISH, Smith-Magenis S51702 FISH, Wolf-Hirschhorn S51720 FISH, SRY/X Centromere S51721 FISH, Prader Willi S51722 FISH, Williams S52723 FISH, X-Linked Ichthyosis Steroid Sulfatase Deficiency S51724 FISH, Kallmann S57103 FISH, Chromosome-Specific Probe (please specify chromosome and band) 5836 HER-2/neu [FISH], Breast Cancer Replacement: S51696 FISH, HER-2/neu, Paraffin Block 5866 MALT Lymphoma by FISH Replacement: S51718 FISH, MALT Lymphoma, MALT1, rea18q21 w/reflex to API2/MALT1, t(11;18) 5870 Mantle Cell Lymphoma t(11;14) by FISH Replacement: S51707 FISH, Mantle Cell Lymphoma, IGH/CCND1, t(11;14) 5845 Multiple Myeloma 5 Probes Replacement: S51713 FISH, Myeloma, 13q, 14q, 17p w/reflex to 5,9, Multiple Myeloma by FISH Replacement: S51712 FISH, Multiple Myeloma, Chromosomes 5,9, Myelodysplastic Syndromes (MDS), Low Grade by FISH Replacement: S51714 FISH, MDS/Myeloid Panel, -5/5q-, -7/7q-, +8,20q 5882 t(12;21) TEL/AML1 by FISH Replacement: S51694 FISH, ALL, TEL/AML1 Translocation 12, Trisomy 11 by FISH 5808 Trisomy 8 [FISH] 5838 X & Y Probe Opposite Sex BM Transplant [FISH] Replacement: S51695 FISH, X/Y, Post Opposite Sex Bone Marrow Transplant 4 of 5
5 Test Changes: Effective November 4, 2008: 1833 ER, PR, Ki-67, p53, HER-2/neu w/reflex FISH, Breast Cancer Component Specimen Source (Add) 1839 ER, PR, Ki-67, HER-2/neu w/reflex FISH, Breast Cancer Component Specimen Source (Add) Component ER Breast Interpretation (Add) Component PR Breast Interpretation (Add) Component HER-2/neu Interpretation (Add) Component Ki-67 Breast Interpretation (Add) 5846 HER-2/neu [IHC] w/reflex FISH, Breast Cancer 1842 ER, PR, HER-2/neu w/reflex FISH, Breast Cancer 1839 ER, PR, Ki-67, HER-2/neu w/reflex FISH, Breast Cancer 1833 ER, PR, Ki-67, p53, HER-2/neu w/reflex FISH, Breast Cancer 1818 ER, PR, DNA CCA, HER-2/neu w/reflex FISH, Breast Cancer HER-2/neu [IHC] will continue to reflex to FISH when result is 2+, for an additional fee. Reflexed panel will be S51696 FISH, HER-2/neu, Paraffin Block 5 of 5
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