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General Biomarkers and Toxicology Assays

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Fujisaka, Y., Yamada, Y., Yamamoto, N., Shimizu, T., Fujiwara, Y., Yamada, K., Tamura, T., Watanabe, H., Sun, Y.N., Bass, M.B., Seki, M. (2010) Phase 1 study of the investigational, oral angiogenesis inhibitor motesanib in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2010 Jan 28. [Epub ahead of print].

Motesanib, Maximum tolerated dose, cKit, Flt 1, VEGFR



Analytes tested using MSD® assays: PlGF (placental growth factor), bFGF (basic fibroblast growth factor), VEGF (Vascular endothelial growth factor receptor), sKDR (soluble KDR), Flt-1 (fms-related tyrosine kinase 1), soluble c-Kit
Matrix tested: Human serum
Summary: This paper provides the results of a phase I clinical trial which examined the safety and pharmacokinetics of an antagonist of VEGF receptors 1, 2 and 3, platelet-derived growth factor receptor, and c-Kit patients with advanced solid tumors.
Kim, C.X., Bailey, K.R., Klee, G.G., Ellington, A.A., Liu, G., Mosley, T.H. Jr, Rehman, H., Kullo, I.J. (2010) Sex and ethnic differences in 47 candidate proteomic markers of cardiovascular disease: the mayo clinic proteomic markers of arteriosclerosis study. Cancer Chemother Pharmacol. 2010 Jan 28.

CVD



Analytes tested using MSD assays: Osteopontin (OPN), Osteoprotegerin (OPG), Osteonectin (ONN), Osteocalcin (OCN)
Matrix tested: Human serum and plasma
Summary: This study investigated multimarker approaches for early detection of cardiovascular disease by measuring the differences in circulating levels of 47 protein markers, suggested to play a role in arteriosclerosis and hypertension, in stored blood samples of 2561 participants.
Thway, T., Macaraeg, C., Calamba, D., Patel, V., Tsoi, J., Ma, M., Lee, J., Desilva, B. (2010) Applications of a planar electrochemiluminescence platform to support regulated studies of macromolecules: Benefits and limitations in assay range. J Pharm Biomed Anal. Vol. 51(3):626-32.

electrochemiluminescence, automated liquid handler



Analytes tested using MSD assays: Three therapeutic antibodies (names not mentioned)
Matrix tested: Cynomolgus monkey serum, rat serum
Summary: The aim of this study was to demonstrate the development, validation and implementation of ECL for regulated studies associated with protein drug development to support pharmacokinetic and toxicokinetic studies.
Mathialagan, S., Poda, G.I., Kurumbail, R.G., Selnessa, S.R., Halla, T., Reitza, B.A., Weinberg, R.A., Kishore, N., Mbalaviele, G. (2010) Expression, purification and functional characterization of IkB kinase-2 (IKK-2) mutants. Protein Expr Purif. Vol. 72(2):254-61.

Nuclear factor kappa B, NF kappa B, NFkB



Analytes tested using MSD assays: User developed assay for IKK-2 kinase activity
Matrix tested: Assay buffer
Summary: In this study, the authors conducted extensive site-directed mutagenesis and computational modeling to generate IKK-2 mutants in order to elucidate the structure–function relationship of IKK-2 inhibitors and enable the further design of IKK-2 inhibitors based on their structure.
Bruey, J.M., Kantarjian, H., Estrov, Z., Zhang, Z., Ma, W., Albitar, F., Abdool, A., Thomas, D., Yeh, C., O'Brien, S., Albitar, M. (2009) Circulating Ki-67 protein in plasma as a biomarker and prognostic indicator of acute lymphoblastic leukemia. Leuk Res. Vol. 34(2):173-6.

Acute lymphoblast leukemia, ECL



Analytes tested using MSD assays: User developed assay for Ki-67, a marker of cellular proliferation
Matrix tested: Human plasma
Summary: In this study, the authors developed an electrochemiluminescence-based immunoassay to explore the prognostic relevance of circulating Ki-67 in plasma in individuals with hematologic disease, using acute lymphoblast leukemia as a model.
Cheng, L.W., Stanker, L.H., Henderson, T.D. 2nd, Lou, J., Marks, J.D. (2009) Antibody protection against botulinum neurotoxin intoxication in mice. Infect Immun. Vol. 77(10):4305-13.

botulism, BoNT/A, BoNT/B, F1-2, F1-40



Analytes tested using MSD assays: Botulinum neurotoxin serotype A
Matrix tested: Mouse serum
Summary: In this study, the ability of monoclonal antibodies to neutralize botulinum toxin serotype A (BoNT/A) was examined in systemic and oral mouse models of botulism.
Cho, C.Y., Keener, W.K., Garber, E.A. (2009) Application of deadenylase electrochemiluminescence assay for ricin to foods in a plate format. J Food Prot. Vol. 72(4):903-6.
Analytes tested using MSD assays: User developed deadenylase assay to measure ricin using MSD Streptavidin plates
Matrix tested: Fruit and vegetable juices
Summary: This study is based on the development of an ECL assay to measure ricin activity in juices on the MSD platform and comparing it with an existing bead based assay. The plate based MSD assay showed better signal / noise ratio and was less sensitive to matrix effects.
Francone, O.L., Tu, M., Royer, L.J., Zhu, J., Stevens, K., Oleynek, J.J., Lin, Z., Shelley, L., Sand, T., Luo, Y., Kane, C.D. (2009) The hydrophobic tunnel present in LOX-1 is essential for oxidized Low-density lipoprotein recognition and binding. J Lipid Res. Vol. 50(3):546-55.

low density lipoprotein, LDL, LDL-oxidation, scavenger receptors



Analytes tested using MSD assays: User developed assay for oxidized LDL / LOX-1 receptor complex
Matrix tested: Assay buffer
Summary: The aim of this study was to identify the functional domains responsible for the binding of oxidized-LDL to the LOX-1 receptor using a series of site-directed mutants that were designed through computer modeling and X-ray crystallography.
Kumar, K.G., Sutton, G.M., Dong, J.Z., Roubert, P., Plas, P., Halem, H.A., Culler, M.D., Yang, H., Dixit, V.D., Butler, A.A. (2009) Analysis of the therapeutic functions of novel melanocortin receptor agonists in MC3R- and MC4R-deficient C57BL/6J mice. Peptides. Vol. 30(10):1892-900.

cAMP, DIO, Obesity, Diabetes, Insulin, Melanocortins, Proopiomelanocortin, Melanocyte-stimulating hormones



Analytes tested using MSD assays: Cyclic AMP
Matrix tested: Cell lysates
Summary: This study examined the effects of novel melanocortin receptor agonists which efficiently reduces food intake, body weight and reverse some aspects of the metabolic syndrome when administered peripherally to diet induced obese mice.
Liang, S., Connell, G.J. (2009) An electrochemiluminescent aptamer switch for a high-throughput assay of an RNA editing reaction. RNA. Vol. 15(10):1929-38.

electrochemiluminescence, Trypanosoma, Lieshmania



Analytes tested using MSD assays: Edited RNA species
Matrix tested: Assay buffer
Summary: In this study, a novel ECL based assay was developed on the MSD platform for the detection of edited RNA in the low femtomole range in a high-throughput format. ECL signal is generated by a conformational change in the RNA induced by the editing.
Migone, T.S., Subramanian, G.M., Zhong, J., Healey, L.M., Corey, A., Devalaraja, M., Lo, L., Ullrich, S., Zimmerman, J., Chen, A., Lewis, M., Meister, G., Gillum, K., Sanford, D., Mott, J., Bolmer, S.D. (2009) Raxibacumab for the Treatment of Inhalational Anthrax. The New England Journal of Medicine. Vol. 361(2):135-144.
Analytes tested using MSD assays: Bacillus anthracis protective antigen
Matrix tested: Rabbit serum, Cynomolgus monkey serum
Summary: This paper provides the results of a randomized, placebo-controlled study in two different animal models of anthrax to assess the efficacy of raxibacumab drug administered as a prophylactic agent and after the onset of systemic disease.
Ohya, T., Miaczynska, M., Coskun, U., Lommer, B., Runge, A., Drechsel, D., Kalaidzidis, Y., Zerial, M. (2009) Reconstitution of Rab- and SNARE-dependent membrane fusion by synthetic endosomes. Nature. Vol. 459(7250):1091-7.

GTPase, intracellular transport, proteoliposome



Analytes tested using MSD assays: Ligand binding assays
Matrix tested: Assay buffer
Summary: In this study, the authors successfully performed an in vitro reconstitution of the intracellular membrane fusion machinery, by using 17 different purified proteins and liposomes, to determine the minimal protein and lipid requirement for endosome fusion. The authors highlighted that the MSD platform provides high sensitivity and dynamic range, as well as minimal background signals.
Ray, C.A., Patel, V., Shih, J., Macaraeg, C., Wu, Y., Thway, T., Ma, M., Lee, J.W., Desilva, B. (2009) Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins. J Pharm Biomed Anal. Vol. 49(2):311-8.

Tecan Evo pipettor, ELISA



Matrix tested: Cynomolgus monkey serum, human serum
Summary: In this paper, the authors describe a multi-factorial design of experiments (DOE) method as a tool for optimizing bridging immunoassays in therapeutic drug measurement and in immunogenicity assessment.
Schoenhoff, F.S, Fu, Q., Van Eyk, J.E. (2009) Cardiovascular proteomics: implications for clinical applications. Clin Lab Med. Vol. 29(1):87-99.

vascular injury panel, CRP, ICAM, VCAM, SAA, multiplex, Bio-Plex



Summary: This article reviews the proteomics techniques with regard to biomarker discovery, validation and verification and discusses the advantages and shortfalls involved in taking proteomics from bench to a clinical setting. MSD technology has been highlighted for its minimal maintenance and robustness.
Sun, D., Hamlin, D., Butterfield, A., Watson, D.E., Smith, H.W. (2009) Electrochemiluminescent immunoassay for rat skeletal troponin I (Tnni2) in serum. J Pharmacol Toxicol Methods. Vol. 61(1):52-8.

cardiac Troponin I, cTnI, monomeric



Analytes tested using MSD assays: Skeletal Troponin I (sTnI)
Matrix tested: Rat serum
Summary: This study is based on the use of MSD technology to develop a sensitive assay that can reliably detect sTnI with minimal cross-reactivity to cTnI in rat serum under reducing conditions. MSD has been highlighted for its dynamic range and the ability for multiplexing.
Tonomura, Y., Mori, Y., Torii, M., Uehara, T. (2009) Evaluation of the usefulness of biomarkers for cardiac and skeletal myotoxicity in rats. Toxicology. Vol. 266(1-3):48-54.

cardiotoxicity, skeletal myotoxocity, acetylcholinesterase, carbofuran, fatty acid binding protein 3 (Fabp3), myosin light chain 1 (MLC1), cardiac troponin I (cTnI), cardiac troponin T (cTnT), aspartate transaminase (AST), lactate dehydrogenase (LDH), creatine kinase (CK)



Analytes tested using MSD assays: Cardiac injury panel 1 (MLC3, Fabp3, cTnI, cTnT)
Matrix tested: Rat serum
Summary: In this study, the authors utilized receiver operating characteristics (ROC) curve analysis to quantitate the relative usefulness of several cardiac and skeletal biomarkers of myotoxicity using two rat models.
Zarrinkar, P.P., Gunawardane, R.N., Cramer, M.D., Gardner, M.F., Brigham, D., Belli, B., Karaman, M.W., Pratz, K.W., Pallares, G., Chao, Q., Sprankle, K.G., Patel, H.K., Levis, M., Armstrong, R.C., James, J., Bhagwat, S.S. (2009) AC220 is a uniquely potent and selective inhibitor of FLT3 for the treatment of acute myeloid leukemia (AML). Blood. Vol. 114(14):2984-2992.

Sunitinib, sorafenib



Analytes tested using MSD assays: User developed assay for Phospho and Total FLT3
Matrix tested: Lysates from MV4-11 and RS4;11 cells, Tumor xenograft lysates, PBMC lysates
Summary: This paper is based on the comparison of a second generation FLT3 inhibitor (therapy for acute myeloid leukemia) with the first generation candidates in terms of potency, selectivity and pharmacokinetics.
Azad, N.S., Posadas, E.M., Kwitkowski, V.E., Steinberg, S.M., Jain, L., Annunziata, C.M., Minasian, L., Sarosy, G., Kotz, H.L., Premkumar, A., Cao, L., McNally, D., Chow, C., Chen, H.X., Wright, J.J., Figg, W.D., Kohn, E.C. (2008) Combination Targeted Therapy With Sorafenib and Bevacizumab Results in Enhanced Toxicity and Antitumor Activity. J Clin Oncol. Vol. 26(22):3709-14.

vascular endothelial growth factor, ovarian cancer



Analytes tested using MSD assays: User developed VEGF assay on MSD avidin coated plates
Matrix tested: Human serum and plasma
Summary: This paper provides the results of a clinical trial to test whether Sorafenib (Raf kinase inhibitor) and Bevacizumab (anti-VEGF antibody) would act in an additive manner against the VEGF pathway so that they can be used as combination therapy in patients with solid tumors.
Collings, F.B., Vaidya, V.S. (2008) Novel technologies for the discovery and quantitation of biomarkers of toxicity. Toxicology. Vol. 245(3):167-74.

toxicoproteomics, metebolomics, software



Summary: This paper reviews the new methods available for the discovery and validation of biomarkers, which significantly reduce assay time and cost and improve the sensitivity of screening methods. ELISA, FAST Quant, SearchLight, MESO SCALE DISCOVERY®, Luminex, silicon nanowire and patterned paper based assays have been discussed here as available technologies for quantitation of markers.
Dao, J.H., Kurzeja, R.J., Morachis, J.M., Veith, H., Lewis, J., Yu, V., Tegley, C.M., Tagari, P. (2008) Kinetic characterization and identification of a novel inhibitor of hypoxia-inducible factor prolyl hydroxylase 2 using a time-resolved fluorescence resonance energy transfer-based assay technology. Anal Biochem. Vol. 384(2):213-23.

electrochemiluminescence, homogeneous time resolved fluorescence resonance energy transfer, TR-FRET



Analytes tested using MSD assays: User developed assay for Km determination of recombinant hydroxylated HIF-1alpha peptide
Matrix tested: Assay buffer
Summary: In this study, the authors developed a novel and high-throughput ECL assay as well as a homogeneous time resolved FRET assay to enzymatically characterize the full-length recombinant human hypoxia-inducible factor prolyl hydroxylases 2 (HIF–PHD2).
Dieterle, F., Marrer, E. (2008) New technologies around biomarkers and their interplay with drug development. Anal Bioanal Chem. Vol. 390(1):141-54.

MESO SCALE DISCOVERY, Luminex, VeraCode



Summary: This is a review paper that provides a critical examination of recently established platforms and technologies for biomarker development, and their applications from discovery to validation in genetics, genomics, proteomics, metabonomics and assay development.
Garber, E.A., O'Brien, T.W. (2008) Detection of ricin in food using electrochemiluminescence-based technology. J AOAC Int. Vol. 91(2):376-82.

biodefense, hook effect



Analytes tested using MSD assays: User developed assay to measure ricin on MSD Streptavidin coated plates
Matrix tested: V8 juice, orange juice, dairy products, soda, vegetables, bakery products, chocolate, condiments
Summary: In this study, the authors developed a highly sensitive and time effective assay to measure ricin in the above matrices.
Gerszten, R.E., Accurso, F., Bernard, G.R., Caprioli, R.M., Klee, E.W., Klee, G.G., Kullo, I., Laguna, T.A., Roth, F.P., Sabatine, M., Srinivas, P., Wang, T.J., Ware, L.B. (2008) Challenges in translating plasma proteomics from bench to bedside: update from the NHLBI Clinical Proteomics Programs. Am J Physiol Lung Cell Mol Physiol. Vol. 295(1):L16-22.

proteome



Summary: This paper discusses the highlights of a meeting held by the National Heart, Lung, and Blood Institute’s (NHLBI) Clinical Proteomics Program committee which focused on the barriers to achieving effective translation of plasma protein biomarkers from discovery to clinical use, and the strategies for overcoming these challenges. The strengths and limitations of multiplexing platforms, including planar assays, bead-based assays and mass spectrometry, have been reviewed.
Karbanova, J., Missol-Kolka, E., Fonseca, A.V., Lorra, C., Janich, P., Hollerova, H., Jaszai, J., Ehrmann, J., Kolar, Z., Liebers, C., Arl, S., Subrtova, D., Freund, D., Mokry, J., Huttner, W.B., Corbeil, D. (2008) The Stem Cell Marker CD133 (Prominin-1) Is Expressed in Various Human Glandular Epithelia. J Hist Cytochem. Vol. 56(11):977–993.
Analytes tested using MSD assays: Monoclonal antibody to human prominin-1
Matrix tested: Hybridoma supernatants
Summary: In this study, the authors investigated the expression profile of prominin-1, which is expressed in various somatic stem cells and progenitor cells, in human glandular epithelia using a new monoclonal antibody. MSD technology was for hybridoma screening of monoclonal antibodies to prominin-1.
Newland, N., Richter, A. (2008) Agents associated with lung inflammation induce similar responses in NCI-H292 lung epithelial cells. Toxicol In Vitro. Vol. 22(7):1782-8 (British American Tobacco).

Interleukin, IL6, IL8



Analytes tested using MSD assays: IL-6, IL-8
Matrix tested: Cell culture supernatant
Summary: In this study, the authors examined the ability of a lung epithelial model to respond to lung toxicants including cigarette smoke total particulate matter, fly ash, bleomycin, lipopolysaccharide, vanadyl sulphate, diesel exhaust particles, and carbon black.
O'Brien, P.J. (2008) Cardiac troponin is the most effective translational safety biomarker for myocardial injury in cardiotoxicity. Toxicology. Vol. 245(3):206-18.

cTnI, cTnT



Summary: This review paper assessed and compared the different biomarkers for myocardial injury and cardiotoxicity, and showed that cardiac Troponin scored much higher than the rest and therefore must be selected as the gold standard biomarker. It has been noted that cardiac Troponin T assays are commercially produced by two vendors only, one being MSD and the other is Roche Diagnostics.
Rottenberg, S., Jaspers, J.E., Kersbergen, A., van der Burg, E., Nygren, A.O., Zander, S.A., Derksen, P.W., de Bruin, M., Zevenhoven, J., Lau, A., Boulter, R., Cranston, A., O'Connor, M.J., Martin, N.M., Borst, P., Jonkers, J. (2008) High sensitivity of BRCA1-deficient mammary tumors to the PARP inhibitor AZD2281 alone and in combination with platinum drugs. PNAS Vol. 105(44):17079-17084.

Poly ADP ribose polymerase 1



Analytes tested using MSD assays: PARP1
Matrix tested: Tumor xenograft lysates
Summary: In this study, the effects of PARP inhibitor, AZD2281, have been tested in a genetically engineered mouse model (GEMM) for BRCA1-associated breast cancer.
Russell, C.B., Suggs, S., Robson, K.M., Kerkof, K., Kivman, L.D., Notari, K.H., Rees, W.A., Leshinsky, N., Patterson, S.D. (2008) Biomarker Sample Collection and Handling in the Clinical Setting to Support Early-Phase Drug in Biomarker Methods in Drug Discovery and Development; Humana Press: 1-26.

Summary: This review provides an insight into the various aspects of biomarker analysis that need to be considered for generating robust data for pharmacodynamic studies. The issues discussed include sample selection, sample collection, and fit-for-purpose assay qualification.
Vicini, J, Etherton, T., Kris-Etherton, P., Ballam, J., Denham, S., Staub, R., Goldstein, D., Cady, R., McGrath, M., Lucy, M. (2008) Survey of retail milk composition as affected by label claims regarding farm-management practices. J Am Diet Assoc. Vol. 108(7):1198-203.
Analytes tested using MSD assays: Insulin-like growth factor-1 (IGF-1), bovine somatotropin (bST)
Matrix tested: Milk
Summary: This study is based on a survey that was conducted to compare the quality (antibiotics and bacterial counts), nutritional value (fat, protein, and solids-not-fat), and hormonal composition (somatotropin, insulin-like growth factor-1, estradiol, and progesterone) of conventional milk, recombinant bovine somatotropin free milk, and organic milk.
Wei, J.S., Badgett, T.C., Khan, J. (2008) New technologies for diagnosing pediatric tumors. Expert Opin Med Diagn. Vol. 2(11):1205-1219.

bead based detection, genomic hybridization, isotope coded affinity tags, label free detection, DNA sequencing, MESO SCALE DISCOVERY, microarray, microRNA, polymerase chain reaction, reverse phase protein array, RT-PCR



Summary: This is a review paper that provides a discussion of new technologies including DNA microarray, multiplexed PCR, bead based assays, and protein detection methods that can be applied to the discovery of biomarkers related to the diagnosis of pediatric cancers.
Batchelor, T., Sorensen, A.G., di Tomaso, E., Zhang, W.T., Duda, D.G., Cohen, K.S., Kozak, K.R., Cahill, D.P., Chen, P.J., Zhu, M., Ancukiewicz, M., Mrugala, M.M., Plotkin, S., Drappatz, J., Louis, D.N., Ivy, P., Scadden, D.T., Benner, T., Loeffler, J.S., Wen, P.Y., Jain, R.K. (2007) AZD2171, a Pan-VEGF receptor tyrosine Kinase Inhibitor, Normalizes tumor vasculature and alleviates edema in glioblastoma patients. Cancer Cell. Vol. 11(1):83-95.

vascular endothelial growth factor receptor, placental growth factor, basic fibroblast growth factor



Analytes tested using MSD assays: VEGF, PlGF, soluble VEGFR1, bFGF
Matrix tested: Human plasma
Summary: This study used MRI techniques to report an immediate and significant normalizing effect of AZD2171 (an oral tyrosine kinase inhibitor of VEGF receptors) in 16 patients with recurrent glioblastoma, with promising tumor responses and biomarker correlations.
Burkhardt, M., Lopez-Acosta, A., Reiter, K., Lopes, V., Lees A. (2007) Purification of soluble CD14 fusion proteins and the use in an electrochemiluminescent assay for lipopolysaccharide binding. Protein Expr Purif. Vol. 51(1):96-101.

Lipopolysaccharide



Analytes tested using MSD assays: User developed assay to measure LPS binding to CD-14
Matrix tested: Assay buffer
Summary: In this study, the authors developed a method for the purification of CD14 (lipopolysaccharide binding protein), and an electrochemiluminescence based assay on the MSD platform to measure the binding of bioactive LPS to CD14. The authors highlighted the dynamic range, minimal washing steps, speed and versatility of the MSD assay.
Guglielmo-Viret, V., Thullier, P. (2007) Comparison of an electrochemiluminescence assay in plate format over a colorimetric ELISA, for the detection of ricin B chain (RCA-B). J Immunol Methods. Vol. 328(1-2):70-8.

bead based assay



Analytes tested using MSD assays: User developed assay for ricin B-chain
Matrix tested: Assay buffer
Summary: In this study, an ECL based assay was developed for the B chain of ricin (RCA-B) on the MSD platform, and this assay was compared to colorimetric ELISA. The ECL assay was shown to be 8-fold more sensitive, had less matrix effects, more robust and was faster than the corresponding ELISA.
Rosen, L., Kurzrock, R., Mulay, M., Van Vugt, A., Purdom, M., Ng, C., Silverman, J., Koutsoukos, A., Sun, Y.N., Bass, M.B., Xu, R.Y., Polverino, A., Wiezorek, J.S., Chang, D.D., Benjamin, R., Herbst, R.S. (2007) Safety, pharmacokinetics, and efficacy of AMG 706, an oral multikinase inhibitor, in patients with advanced solid tumors. J Clin Oncol. Vol. 25(17):2369-76.

vascular endothelial growth factor receptor, placental growth factor, basic fibroblast growth factor, sKit



Analytes tested using MSD assays: VEGF, PlGF, soluble VEGFR1, bFGF, soluble VEGFR2, soluble Kit
Matrix tested: Human serum
Summary: This study is based on a phase I, open-label, sequential dose-escalating clinical trial of AMG 706 (inhibits VEGFR1, VEGFR2, VEGFR3, PlGF receptor, and Kit) in patients with advanced solid tumors, and demonstrated the tolerability, anti-tumor activity and favorable pharmacokinetics of AMG 706.
Shi, M. (2007) Biomarker Development Strategies - surmounting scientific and regulatory barriers in bringing innovative medicine to market. IDrugs. Vol. 10(4):246-8.
Summary: This paper provides the highlights of Biomarker Development Strategies conference held in Washington DC on 29th and 30th of December 2007, which focused on the progress of biomarker strategies and regulatory frameworks that enable decision-making in pharmaceutical development and early diagnosis of disease. MSD platform was highlighted for its use in the phase I clinical trial of AMG-706, wherein, plasma vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFG)F, placental growth factor (PlGF), c-Kit, sFlt-1 and soluble kinase insert domain receptor (sKDR) were measured by using multiplex assays.
Wu, S.J., Schmidt, A., Beil, E.J., Day, N.D., Branigan, P.J., Liu, C., Gutshall, L.L., Palomo, C., Furze, J., Taylor, G., Melero, J.A., Tsui, P., Del Vecchio, A.M., Kruszynski, M. (2007) Characterization of the epitope for anti-human respiratory syncytial virus F protein monoclonal antibody 101F using synthetic peptides and genetic approaches. J Gen Virol. Vol. 88(Pt 10):2719-23.

anti-human respiratory syncytial virus, palivizumab, chimeric 101F



Analytes tested using MSD assays: User developed assay to detect binding of RSV F-protein peptides to anti-RSV drug
Matrix tested: Assay buffer
Summary: In this study, the epitope on the human RSV F-glycoprotein recognized by a neutralizing monoclonal antibody, ch101F, was mapped by using three methods: a) binding of the synthetic peptides covering the amino acid 422–438 sequence region of F protein; b) binding to recombinant F proteins expressed at the cell surface and containing mutations at positions 427, 429 and 433; and c) selection of antibody escape mutant viruses.
Wang, X., Simmons, H. A., Salatto, C. T., Cosgrove, P. G., Thompson, D. D. (2006) Lasofoxifene enhances vaginal mucus formation without causing hypertrophy and increases estrogen receptor [beta] and androgen receptor in rats. Menopause. Vol. 13(4):609-620.

Lasofoxifene



Analytes tested using MSD assays: Estrogen receptor (ER), Estrogen receptor beta (ERß), progesterone receptor (PR), androgen receptor (AR)
Matrix tested: Rat vaginal homogenates
Summary: The focus of this study was to elucidate the molecular and cellular basis of the unique effects of Lasofoxifene, a selective estrogen-receptor modulator (SERM), in OVX immature rat model. Lasofoxifene showed efficacy in vaginal and vulvar atrophy.
Wilkinson-Berka, J. L., Jones, D., Taylor, G., Jaworski, K., Kelly, D. J., Ludbrook, S. B., Willette, R. N., Kumar, S., Gilbert, R.E. (2006) SB-267268, a Nonpeptidic Antagonist of vß3 and vß5 Integrins, Reduces Angiogenesis and VEGF Expression in a Mouse Model of Retinopathy of Prematurity. Invest Ophthalmol Vis Sci. Vol. 47(4):1600-5.

angiogenesis



Analytes tested using MSD assays: Integrin / ligand binding assay
Matrix tested: Assay buffer
Summary: This study examined whether the administration of SB-267268 (antagonist of avß3 and avß5 integrins) reduces retinal angiogenesis in mice with ROP and alters the expression of retinal VEGF and VEGFR2.
Tew, D.J., Johnson, J.K., Maxey, K.M. (2005) Platforms for Eicosanoid Measurements. Genetic Engineering News. Vol. 25(20):34.

fluorescence polarization immunoassay (FPIA)



Analytes tested using MSD assays: PGE2, PGD2, TXB2, CTC4, LTB4
Matrix tested: Assay buffer
Summary: This paper describes the development of immunoassays for prostaglandins (PGE2, PGD2), thromboxanes (TXB2), and leukotrienes (CTC4 and LTB4) by Cayman Chemical (www.caymanchemical.com) using Luminex, MESO SCALE DISCOVERY and fluorescence polarization.
Willett, C.G., Boucher, Y., Duda, D.G., di Tomaso, E., Munn, L.L., Tong, R.T., Kozin, S.V., Petit, L., Jain, R.K., Chung, D.C., Sahani, D.V., Kalva, S.P., Cohen, K.S., Scadden, D.T., Fischman, A.J., Clark, J.W., Ryan, D.P., Zhu, A.X., Blaszkowsky, L.S., Shellito, P.C., Mino-Kenudson, M., Lauwers, G.Y. (2005) Surrogate markers for antiangiogenic therapy and dose-limiting toxicities for bevacizumab with radiation and chemotherapy: continued experience of a phase I trial in rectal cancer patients. J Clin Oncology. Vol. 23(31): 8136-8139.

vascular endothelial growth factor receptor, placental growth factor



Analytes tested using MSD assays: VEGF, PlGF
Matrix tested: Human plasma
Summary: This study provides the results of a clinical trial where patients with advanced rectal carcinoma were treated with Bevacizumab at 10 mg/kg on day 1, given concurrent administration of Bevacizumab on days 15, 29, 43 along with fluorouracil chemotherapy and pelvic radiation therapy.

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