Review Article

Tissue Banking, Bioinformatics, and Electronic Medical Records: The Front-End Requirements for Personalized Medicine

Table 1

List of biomarkers and personalized medicines with companion diagnostics.

BiomarkerCancer type (subtype)Companion diagnostics (company)Drug therapy (company)Reference

HER2 (gene amplification)Breast cancer (HER 2 positive) **SPoT-Light HER2 CISH **Hercep test (Life Technologies, NY) **Herceptin, trastuzumab (Hoffman La Roche Inc.) [13, 14]

ALK (chromosome rearrangement)Nonsmall cell lung cancer (anaplastic lymphoma kinase (ALK) positive advanced nonsmall cell lung cancer) **Vysis ALK FISH test (Abbott Laboratories, Abbott, IL) **Xalkori, crizotinib (Pfizer)[13, 15]

EGFR KRAS (mutation)Colorectal Cancer (expressing metastatic colorectal carcinoma, EGFR) **Therascreen KRAS Test (Qiagen, Corporate Headquarters, Nederland’s) **Erbitux, cetuximab (ImClone, ImClone Systems, NJ) **Vectibix, panitumumab (Amgen, Amgen Inc,. CA)[13, 16, 17]

BRAF V600E (mutation)Melanoma (metastatic melanoma with BRAFV600E mutation) **Cobas 4800 BRAF V600 Mutation Test (Panagene, Corporate Headquarters, Korea) **Zelboraf, vemurafenib (Genentech/Roche)[13, 18]

BRCA1/2 (gene translocation)Breast cancer (median, triple-negative, HER2+, and ER+/HER2−)N/A *Veliparib, ABT-888 (Abbott)
*Olaparib, AZD2281 (Abbott)
[13, 19, 20]

PML-RAR (gene translocation)Acute Promyelocytic LeukemiaN/A **Trisenox, arsenic trioxide (Teva, Israel)[13, 23]

BCR-ABL (gene translocation)Chronic myelogenous leukemiaN/A **Gleevec, imatinib (Novartis)
**Sprycel, dasatinib (Bristol Myers Squibb)
**Tasigna, nilotinib (Novartis)
[13, 24, 25]

C kit, FIP1L1-PDGFRαChronic myeloid leukemia (Ph+ CML) gastrointestinal stromal tumor (GIST) **DAKO C-KIT PharmDx **Dako North America, Inc.[26]

CD 20Non-Hodgkins lymphoma (CD20+ follicular B-cell non-Hodgkin’s lymphoma) *Rituxan Sensitivity (CD20), Flow cytometry assay **Bexxar, tositumomab (GlaxoSmithKine) [27]

CD 25T-cell lymphoma (cutaneous T-cell lymphoma,) *ONTAK Sensitivity (CD25), Flow Cytometry (Quest Diagnostics) **Ontak, denileukin diftitox (Marathon Biopharmaceuticals Inc. MA)[28]

CD 30Refractory Hodgkins lymphoma *Fluorescent microsphere immunoassay, (Quest Diagnostics) **Adcetris, brentuximab vedotin (Seattle genetics Inc.) Corporate Headquarters, Seattle Genetics, Inc., WA, USA.[29]

TPMT(CD30+ lymphoma) *TPMT Activity, Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS) (Quest Diagnostics) **Tabloid, thioguanine (GlaxoSmithKine) [30]

DPDBreast cancer (with TS, MTHFR, and DPD gene polymorphisms) *Polymerase Chain Reaction (PCR) Single Nucleotide Primer Extension **Xeloda, capecitabine (Hoffman La Roche Inc.) [31]

ER-PGRBreast cancer (ER and/or PGR+) *Immunohistochemistry (IHC) (Quest Diagnostics) **Aromasin, exemestane (Pfizer) [32]

G6PDLymphoma, leukemia (lymphoid leukemia (B and T cell), non-Hodgkin’s lymphoma (including Burkitt’s lymphoma) or acute myelogenous leukemia)N/A **Elitek, rasburicase (Sanofi-synthelabo Inc.) [33]

ERBreast cancer (low-grade ER−/PR+) *Immunohistochemical Assay (Quest Diagnostics) *Nolvadex, tamoxifen (AstraZeneca) [34]

ERBreast cancer (ER+)N/A *Arimidex, anastrozole (AstraZeneca) [35]

ERBreast cancer (ER+ and/or PgR+)N/A **Faslodex, fulvestrant (AstraZeneca)[36]

UGT1A1Colorectal cancer (UGT1A1*28 polymorphisms) *Fluorescent polymerase chain reaction (PCR) with primers specific for the 5′ untranslated region of UGT1A1 (Third Wave Technologies, WI) **Camptosar, irinotecan (Pfizer) [37]

ERCC1Gastrooesophageal cancer (with ERCC1 nuclear protein expression)N/A *Camptosar, irinotecan (Pfizer) [38]

TPMTMetastatic Testicular tumors
Metastatic ovarian tumors
Advanced bladder cancer
N/A *Platinol, cisplatin, (Bristol-Myers Squibb Company)[39]

TPMTAcute nonlymphocytic leukemiasN/A **Tabloid, thioguanine (GlaxoSmithKline) [40]

CDK 4 and 6Breast cancer (luminal estrogen receptor-ER+, HER2−)N/A *Palbociclib, PD-0332991 (Pfizer) [41]

This biomarkers are used for diagnostic and prognostic purposes to determine the proper cause of treatment (investigational diagnostics and/or drugs).
**FDA approved diagnostics and/or drugs.