PIK3CA Mutation CDx – Tissue is an FDA-approved qualitative companion diagnostic assay performed on DNA extracted from FFPE breast tissue to detect 11 mutations in exons 7, 9, and 20 of the PIK3CA gene. Completion of the PIK3CA Mutation CDx Test Request Form with provider’s signature is required for this CDx test.

Alternate Name: QIAGEN therascreen® PIK3CA RGQ PCR

FGFR CDx Molecular Analysis is the first companion diagnostic test for identification of fibroblast growth factor receptor alterations in urothelial carcinoma. Patients with FGFR alterations identified by this test may be eligible for treatment with BALVERSA™ (erdafitinib) which is indicated for patients with locally advanced or metastatic urothelial carcinoma who have progressed on platinum-based chemotherapy.1

FGFR plays an important role in cell development, differentiation, survival, migration, angiogenesis and carcinogenesis2. FGFR aberrations can contribute to carcinogenic events by influencing PI3K/AKT, STAT and RAS/MAPK pathways3. FGFR3 abnormalities accounts for ~70% of non-muscle-invasive bladder cancers and 10-20% of invasive bladder cancers4. FGFR3 is considered as an important therapeutic target in both non-invasive and invasive UC5.

Alternative Name: therascreen® FGFR RGQ RT-PCR Kit


  1. FDA approves first targeted therapy for metastatic bladder cancer. Office Commissioner – https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-metastatic-bladder-cancer. Accessed May 9, 2019.
  2. Helsten T, Elkin S, Arthur E, Tomson BN, Carter J, Kurzrock R. The FGFR Landscape in Cancer: Analysis of 4,853 Tumors by Next-Generation Sequencing. Clinical Cancer Research. 2015;22(1):259-267. doi:10.1158/1078-0432.ccr-14-3212.
  3. Costa R, Carneiro B, Taxter T, et.al. FGFR3-TACC3 fusion in solid tumors: mini review. Oncotarget. 2016;7(34):55924-55938. doi: 10.18632/oncotarget.10482.
  4. Chae YK, Ranganath K, Hemmerman P, et.al. Inhibition of the fibroblast growth factor receptor (FGFR) pathway: the current landscape and barriers to clinical application. Oncotarget. 2017;8(9):16052-16074. doi: 10.18632/oncotarget.14109.
  5. Williams S, Hurst C and Knowles M. Oncogenic FGFR3 gene fusions in bladder cancer. Human Molecular Genetics. 2013;22(4):795-803. doi:10.1093/hmg/dds486

Available as an add-on in conjunction with, or after, a Diagnostic/Prognostic Profile result has been reported by Genoptix or client. Markers performed by flow cytometry include cCD3, CD1a, CD3, CD4, CD8, CD10, CD45 and TdT.

Amplification of the ERBB2 gene (encoding for HER2 protein) is detected by fluorescent in
situ hybridization (FISH) in human breast and esophagogastric cancer tissue specimens.

The Bladder Cancer FISH test designed to detect aneuploidy for chromosomes 3, 7 and 17 and the 9p21 locus in urine specimens. This test is an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

PD-L1 IHC 22C3 is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein. PD-L1 IHC 22C3 is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab).

Cytogenetic abnormalities commonly associated with high-grade B-cell non-Hodgkin lymphomas (NHL) are detected by fluorescence in situ hybridization (FISH). Probes for BCL6 (3q27.3), IRF4-DUSP22 (6p25.3), MYC (8q24.21), IGH/BCL2 t(14;18)) are included in the B-NHL – High Grade FISH Profile (Enriched). B-cells are enriched from patient’s specimen using immunomagnetic enrichment technology with CD19/CD20 antibodies.

Cytogenetic abnormalities commonly associated with acute lymphoblastic leukemia (ALL) are detected by fluorescence in situ hybridization (FISH). Probes for TCF3/PBX1 t(1;19), BCR/ABL1-ASS1 t(9;22), CDKN2A (9p21.3), KMT2A (MLL)(11q23.3), ETV6/RUNX1 t(12;21)/(iAMP21), IGH (14q32.3), TP53 (17p13.1) are included in the ALL FISH Profile.

A tech-only 25-marker screening profile for peripheral blood specimens. An evaluation of specimen adequacy and cellular integrity will also be performed. Markers include CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD13, CD14, CD16, CD19, CD20, CD23, CD34, CD38, CD45, CD56, CD57, CD103, CD117, FMC 7, HLADR, Kappa, and Lambda.

A tech-only 20-marker screening profile for fresh tissue specimens. An evaluation of specimen adequacy and cellular integrity will also be performed. Markers include CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD14, CD19, CD20, CD23, CD34, CD38, CD45, CD56, CD57, CD200, FMC 7, Kappa and Lambda.