Publications using
In Vivo MutaFlow Kits

(Pig-a Gene Mutation Analysis)

In Vivo Pig-a gene mutation assay: Guidance for 3Rs-friendly implementation

M. Raschke1, B.W. Igl1, J. Kenny2, J. Collins2, S.D. Dertinger3, C. Labash3, J.A. Bhalli4, C.C.M. Tebbe4, K.M. McNeil4, A. Sutter1

1 Bayer Pharma AG
2 GlaxoSmithKline
3 Litron Laboratories,
4 Covance Laboratories Inc

Environmental and Molecular Mutagenesis
Volume 57, Issue 9, December 2016, Pages 678–686
Diet-induced obesity increases the frequency of Pig-a mutant erythrocytes in male C57BL/6J mice

J.K. Wickliffe1, S.D. Dertinger2, D.K. Torous2, S.L. Avlasevich2, B.R. Simon-Friedt1, M.J. Wilson1

1 Tulane University
2 Litron Laboratories

Environmental and Molecular Mutagenesis
Volume 57, Issue 9, December 2016, Pages 668–677
Gamma radiation at a human relevant low dose rate is genotoxic in mice

A. Graupner1,2, D.M. Eide1,2, C. Instanes1,2, J.M. Andersen1,2, D.A. Brede2, S.D. Dertinger3, O.C. Lind2, A. Brandt-Kjelsen2, H. Bjerke4, B. Salbu2, D. Oughton2, G. Brunborg1,2, A.K. Olsen1,2

1 Norwegian Institute of Public Health
2 Centre for Environmental Radioactivity (CoE CERAD)
3 Litron Laboratories
4 Norwegian Radiation Protection Authority

Scientific Reports
Volume 6, 06 September 2016, Article 32977
Cigarette smoke induced genotoxicity and respiratory tract pathology: evidence to support reduced exposure time and animal numbers in tobacco product testing

A. Dalrymple1, P. Ordoñez2, D. Thorne1, D. Walker1, O.M. Camacho1, A. Büttner3, D. Dillon1, C. Meredith1

1 British American Tobacco
2 Vivotecnia Research S.L.
3 Histovia GmbH

Inhalation Toxicology
Volume 28, Issue 7, June 2016, Pages 324-338
Empirical analysis of BMD metrics in genetic toxicology part II: in vivo potency comparisons to promote reductions in the use of experimental animals for genetic toxicity assessment

J.W. Wills1, A.S. Long1, G.E. Johnson2, J.C. Bemis3, S.D. Dertinger3, W.Slob4, P.A. White1

1 Health Canada
2 Swansea University Medical School
3 Litron Laboratories
4 National Institute for Public Health and the Environment (RIVM)

Mutagenesis
Volume 31, Issue 3, May 2016, Pages 265-275
In vivo genotoxicity assessment of acrylamide and glycidyl methacrylate

V.N. Dobrovolsky1, M.M. Pacheco-Martinez2, L.P. McDaniel1, M.G. Pearce1, W. Ding1

1 National Center for Toxicological Research, US Food and Drug Administration
2 Universidad Autónoma Metropolitana Iztapalapa

Food and Chemical Toxicology
Volume 87, January 2016, Pages 120–127
Comparison of integrated genotoxicity endpoints in rats after acute and subchronic oral doses of 4-nitroquinoline-1-oxide

D.J. Roberts1,2, M. McKeon3, Y. Xu3, L.F. Stankowski4

1 Bristol-Myers Squibb
2 Rutgers
3 BioReliance Corporation
4 WIL Research

Environmental and Molecular Mutagenesis
Volume 57, Issue 1, January 2016, Pages 17–27
Dietary folic acid protects against genotoxicity in the red blood cells of mice

A.J. MacFarlane1, N.A. Behan1, M.S. Field2, A. Williams1, P.J. Stover2, C.L. Yauk1

1 Health Canada
2 Cornell University

Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis
Volume 779, September 2015, Pages 105–111
Characterisation of an in vivo Pig-a gene mutation assay for use in regulatory toxicology studies

J. Godin-Ethier, F. Leroux, N. Wang, S. Thébaud, F. Merah, A. Nelson

ITR Laboratories Canada, Inc.

Mutagenesis
Volume 30, Issue 3, May 2015, Pages 359-363
Comparison of male versus female responses in the Pig-a mutation assay

C. Labash1, S.L. Avlasevich1, K. Carlson1, D.K. Torous1, A. Berg1, J.C. Bemis1, J.T. MacGregor2, S.D. Dertinger1

1 Litron Laboratories
2 Toxicology Consulting Services

Mutagenesis
Volume 30, Issue 3, May 2015, Pages 349-357
Rat Pig-a mutation assay responds to the genotoxic carcinogen ethyl carbamate but not the non-genotoxic carcinogen methyl carbamate

J.C. Bemis1, C. Labash1, S.L. Avlasevich1, K. Carlson1, A. Berg1, D.K. Torous1, M. Barragato1, J.T. MacGregor2, S.D. Dertinger1

1 Litron Laboratories
2 Toxicology Consulting Services

Mutagenesis
Volume 30, Issue 3, May 2015, Pages 343-347
Compensatory erythropoiesis has no impact on the outcome of the in vivo Pig-a mutation assay in rats following treatment with the haemolytic agent 2-butoxyethanol

M.O. Kenyon1, S.L. Coffing1, J.I. Ackerman1, W.C. Gunther1, S.D. Dertinger2, K. Criswell1, K.L. Dobo1

1 Pfizer Worldwide Research and Development
2 Litron Laboratories

Mutagenesis
Volume 30, Issue 3, May 2015, Pages 325-334
Evaluation of the in vivo mutagenicity of isopropyl methanesulfonate in acute and 28-day studies

S.L. Coffing, M.O. Kenyon, J.I. Ackerman, T.J. Shutsky, K.L. Dobo

Pfizer Worldwide Research and Development

Environmental and Molecular Mutagenesis
Volume 56, Issue 3, April 2015, Pages 322–332
Genotoxic effects of two-generational selenium deficiency in mouse somatic and testicular cells

A. Graupner1, C. Instanes1, J.M. Andersen1, A. Brandt-Kjelsen2, S.D. Dertinger3, B. Salbu2, G. Brunborg1, A.K. Olsen1

1 National Institute of Public Health
2 University of Life Sciences
3 Litron Laboratories

Mutagenesis
Volume 30, Issue 2, March 2015, Pages 217-225
Genotoxicity assessment of melamine in the in vivo Pig-a mutation assay and in a standard battery of assays

H. Tu, M. Zhang, C. Zhou, Z. Wang, P. Huang, H. Ou, Y. Chan

National Shanghai Center for New Drug Safety Evaluation & Research, China State Institute of Pharmaceutical Industry

Mutation Research/Genetic Toxicology and Environmental Mutagenesis
Volume 777, 1 January 2015, Pages 62–67
Assessment of 5-fluorouracil and 4-nitroquinoline-1-oxide in vivo genotoxicity with Pig-a mutation and micronucleus endpoints

C. Zhou1, M. Zhang1, P. Huang1, H. Tu1, Z. Wang1, S.D. Dertinger2, D.K. Torous2, Y. Chang1

1 National Shanghai Center for New Drug Safety Evaluation and Research, China State Institute of Pharmaceutical Industry
2 Litron Laboratories

Environmental and Molecular Mutagenesis
Volume 55, Issue 9, December 2014, Pages 735–740
Single cell gel electrophoresis (SCGE) and Pig-a mutation assay in vivo-tools for genotoxicity testing from a regulatory perspective: a study of benzo[a]pyrene in Ogg1-/- mice

A. Graupner1, C. Instanes1, S.D. Dertinger2, J.M. Andersen1, B. Lindeman1, T.D. Rongved1, G. Brunborg1, A.K. Olsen1

1 Norwegian Institute of Public Health
2 Litron Laboratories

Mutation Research/Genetic Toxicology and Environmental Mutagenesis
Volume 772, 15 September 2014, Pages 34–41
Persistence of cisplatin-induced mutagenicity in hematopoietic stem cells: implications for secondary cancer risk following chemotherapy

S.D. Dertinger1, S.L. Avlasevich1, D.K. Torous1, J.C. Bemis1, S. Phonethepswath1, C. Labash1, K. Carlson1, J. Mereness1, J. Cottom1, J. Palis2, J.T. MacGregor3

1 Litron Laboratories
2 University of Rochester Medical Center
3 Toxicology Consulting Services

Toxicological Sciences
Volume 140, Issue 2, 01 August 2014, Pages 307-314
Evaluation of the Pig-a, micronucleus, and comet assay endpoints in a 28-day study with ethyl methanesulfonate

W.C. Gunther1, S.L. Coffing1, D.A. Dickinson1, M.E. Engel1, R.D. Fiedler2, S.D. O'Lone1, K.E. Sanok1, C.J. Thiffeault2, T.J. Shutsky1, M.J. Schuler1, K.L. Dobo1

1 Pfizer Global Research and Development
2 Covance Genetic Toxicology

Environmental and Molecular Mutagenesis
Volume 55, Issue 6, July 2014, Pages 492–499
Diethylnitrosamine genotoxicity evaluated in sprague dawley rats using pig-a mutation and reticulocyte micronucleus assays

S.L. Avlasevich1, S. Phonethepswath1, C. Labash1, K. Carlson1, D.K. Torous1, J. Cottom1, J.C. Bemis1, J.T. MacGregor2, S.D. Dertinger1

1 Litron Laboratories
2 Toxicology Consulting Services

Environmental and Molecular Mutagenesis
Volume 55, Issue 5, June 2014, Pages 400–406
Pig-a gene mutation and micronucleated reticulocyte induction in rats exposed to tumorigenic doses of the leukemogenic agents chlorambucil, thiotepa, melphalan, and 1,3-propane sultone

S.D. Dertinger1, S. Phonethepswath1, S.L. Avlasevich1, D.K. Torous1, J. Mereness1, J. Cottom1, J.C. Bemis1, J.T. MacGregor2

1 Litron Laboratories
2 Toxicology Consulting Services

Environmental and Molecular Mutagenesis
Volume 55, Issue 4, May 2014, Pages 299–308
Assessment of the genotoxic potential of azidothymidine in the comet, micronucleus, and Pig-a assay

M. Guérard1, J. Koenig1, M. Festag1, S.D. Dertinger2, T. Singer1, G. Schmitt1, A. Zeller1

1 F. Hoffmann-La Roche AG
2 Litron Laboratories

Toxicological Sciences
Volume 135, Issue 2, October 2013, Pages 309-316
Sensitivity of the Pig-a assay for detecting gene mutation in rats exposed acutely to strong clastogens

J.A. Bhalli, J.G. Shaddock, M.G. Pearce, V.N. Dobrovolsky

National Center for Toxicological Research, US Food and Drug Administration

Mutagenesis
Volume 28, Issue 4, July 2013, Pages 447-455
Evaluating the weak in vivo micronucleus response of a genotoxic carcinogen, aristolochic acids

J.A. Bhalli, W. Ding, J.G. Shaddock, M.G. Pearce, V.N. Dobrovolsky, R.H. Heflich

National Center for Toxicological Research, U.S. Food and Drug Administration

Mutation Research/Genetic Toxicology and Environmental Mutagenesis
Volume 753, Issue 2, 15 May 2013, Pages 82–92
Flow cytometric analysis of Pig-a gene mutation and chromosomal damage induced by procarbazine hydrochloride in CD-1 mice

S. Phonethepswath1, S.L. Avlasevich1, D.K. Torous1, J. Mereness1, J.C. Bemis1, J.T. MacGregor2, S.D. Dertinger1

1 Litron Laboratories
2 Toxicology Consulting Services

Environmental and Molecular Mutagenesis
Volume 54, Issue 4, May 2013, Pages 294–298
Efficient monitoring of in vivo pig-a gene mutation and chromosomal damage: summary of 7 published studies and results from 11 new reference compounds

S.D. Dertinger1, S. Phonethepswath1, S.L. Avlasevich1, D.K. Torous1, J. Mereness1, S.M. Bryce1, J.C. Bemis1, S. Bell1, P. Weller1, J.T. MacGregor2

1 Litron Laboratories
2 Toxicology Consulting Services

Toxicological Sciences
Volume 130, Issue 2, December 2012, Pages 328-348
In vivo flow cytometric Pig-a and micronucleus assays: highly sensitive discrimination of the carcinogen/noncarcinogen pair benzo(a)pyrene and pyrene using acute and repeated-dose designs

D.K. Torous1, S. Phonethepswath1, S.L. Avlasevich1, J. Mereness1, S.M. Bryce1, J.C. Bemis1, P. Weller1, S. Bell1, C. Gleason2, L.L. Custer2, J.T. MacGregor3, S.D. Dertinger1

1 Litron Laboratories
2 Bristol-Myers Squibb
3 Toxicology Consulting Services

Environmental and Molecular Mutagenesis
Volume 53, Issue 6, July 2012, Pages 420–428
Simultaneous measurement of benzo[a]pyrene-induced Pig-a and lacZ mutations, micronuclei and DNA adducts in Muta™ Mouse

C.L. Lemieux1, G.R. Douglas1, J. Gingerich1, S. Phonethepswath2, D.K. Torous2, S.D. Dertinger2, D.H. Phillips3, V.M. Arlt3, P.A. White1

1 Health Canada
2 Litron Laboratories
3 Institute of Cancer Research

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 756–765
Interlaboratory Pig-a gene mutation assay trial: Studies of 1,3-propane sultone with immunomagnetic enrichment of mutant erythrocytes

S.D. Dertinger1, S. Phonethepswath1, P. Weller1, S. Avlasevich1, D.K. Torous1, J.A. Mereness1, S.M. Bryce1, J.C. Bemis1, S. Bell1, S. Portugal2, M. Aylott3, J.T. MacGregor4

1 Litron Laboratories
2 Pfizer Global R&D
3 GlaxoSmithKline
4 Toxicology Consulting Services

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 748–755
Integration of Pig-a, micronucleus, chromosome aberration, and Comet assay endpoints in a 28-day rodent toxicity study with 4-nitroquinoline-1-oxide

L.F. Stankowski, D.J. Roberts, H. Chen, T. Lawlor, M. McKeon, H. Murli, A. Thakur, Y. Xu

Covance Laboratories

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 738–747
Report on stage III Pig-a mutation assays using benzo[a]pyrene

J.A. Bhalli1, J.G. Shaddock1, M.G. Pearce1, V.N. Dobrovolsky1, X. Cao1, R.H. Heflich1, H.W. Vohr2

1 National Center for Toxicological Research, U.S. Food and Drug Administration
2 Bayer HealthCare AG

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 731–737
Report on stage III Pig-a mutation assays using N-ethyl-N-nitrosourea-comparison with other in vivo genotoxicity endpoints

Z. Cammerer1, J.A. Bhalli2, X. Cao2, S.L. Coffing1, D. Dickinson1, K.L. Dobo1, V.N. Dobrovolsky2, M. Engel1, R.D. Fiedler1, W.C. Gunther1, R.H. Heflich2, M.G. Pearce2, J.G. Shaddock2, T. Shutsky1, C.J. Thiffeault1, M. Schuler1

1 Pfizer Global Research and Development
2 U.S. Food and Drug Administration/National Center for Toxicological Research

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 721–730
Assessment of genotoxicity induced by 7,12-dimethylbenz(a)anthracene or diethylnitrosamine in the Pig-a, micronucleus and Comet assays integrated into 28-day repeat dose studies

J. Shi, L. Krsmanovic, S. Bruce, T. Kelly, M. Paranjpe, K. Szabo, M. Arevalo, S. Atta-Safoh, F. Debelie, M. Klug LaForce, J. Sly, S. Springer

BioReliance Corporation

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 711–720
International Pig-a gene mutation assay trial (stage III): results with N-methyl-N-nitrosourea

A.M. Lynch1, A. Giddings1, L. Custer2, C. Gleason2, A. Henwood2, M. Aylott1, J. Kenny1

1 GlaxoSmithKline
2 Bristol-Myers Squibb

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 699–710
International Pig-a gene mutation assay trial: evaluation of transferability across 14 laboratories

S.D. Dertinger1, S. Phonethepswath1, P. Weller1, J. Nicolette2, Jo. Murray2, P. Sonders2, H.W. Vohr3, J. Shi4, L. Krsmanovic4, C. Gleason5, L. Custer5, A. Henwood5, K. Sweder5, L.F. Stankowski6, D.J. Roberts6, A. Giddings7, J. Kenny7, A.M. Lynch7, C. Defrain8, F. Nesslany8, B.J.M. van der Leede9, T. Van Doninck9, A. Schuermans9, K. Tanaka10, Y. Hiwata10, O. Tajima10, E. Wilde11, A. Elhajouji11, W.C. Gunther12, C.J. Thiffeault12, T.J. Shutsky12, R.D. Fiedler12, T. Kimoto13, J.A. Bhalli14, R.H. Heflich14, J.T. MacGregor15

1 Litron Laboratories
2 Abbott Laboratories
3 Bayer Pharma AG
4 BioReliance Corporation
5 Bristol-Myers Squibb
6 Covance Laboratories,
7 GlaxoSmithKline, Ware
8 Institut Pasteur de Lille
9 Janssen Pharmaceutical Companies of Johnson & Johnson
10 Kirin Group Office Co. Ltd.
11 Novartis Institutes for Biomedical Research
12 Pfizer Global R&D
13 Teijin Pharma Ltd.
14 U.S. FDA/NCTR
15 Toxicology Consulting Services

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 690–698
Need and potential value of the Pig-a in vivo mutation assay-a HESI perspective

M. Schuler1, B.B. Gollapudi2, V. Thybaud3, J.H. Kim4

1 Pfizer Global Research and Development
2 The Dow Chemical Company
3 Sanofi-Aventis
4 ILSI Health and Environmental Sciences Institute

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 685–689
In vivo assessment of Pig-a gene mutation-recent developments and assay validation

S.D. Dertinger1, R.H. Heflich2

1 Litron Laboratories
2 U.S. Food and Drug Administration/National Center for Toxicological Research

Environmental and Molecular Mutagenesis
Volume 52, Issue 9, December 2011, Pages 681–684
Defining EMS and ENU dose-response relationships using the Pig-a mutation assay in rats

K.L. Dobo, R.D. Fiedler, W.C. Gunther, C.J. Thiffeault, Z. Cammerer, S.L. Coffing, T. Shutsky, M. Schuler

Pfizer Global Research and Development

Mutation Research/Genetic Toxicology and Environmental Mutagenesis
Volume 725, Issues 1–2, 9 October 2011, Pages 13–21
When pigs fly: immunomagnetic separation facilitates rapid determination of Pig-a mutant frequency by flow cytometric analysis

S.D. Dertinger, S.M. Bryce, S. Phonethepswath, S.L. Avlasevich

Litron Laboratories

Mutation Research/Genetic Toxicology and Environmental Mutagenesis
Volume 721, Issue 2, 3 April 2011, Pages 163–170
The in vivo Pig-a gene mutation assay, a potential tool for regulatory safety assessment

V.N. Dobrovolsky1, D. Miura2, R.H. Heflich1, S.D. Dertinger3

1 U.S. Food and Drug Administration, National Center for Toxicological Research
2 Teijin Pharma Ltd.
3 Litron Laboratories

Environmental and Molecular Mutagenesis
Volume 51, Issue 8-9, October - December 2010, Pages 825–835
Integration of mutation and chromosomal damage endpoints into 28-day repeat dose toxicology studies

S.D. Dertinger1, S. Phonethepswath1, D. Franklin1, P. Weller1, D.K. Torous1, S.M. Bryce1, S. Avlasevich1, J.C. Bemis1, O. Hyrien2, J. Palis2, J.T. MacGregor3

1 Litron Laboratories
2 University of Rochester Medical Center
3 Toxicology Consulting Services

Toxicological Sciences
Volume 115, Issue 2, June 2010, Pages 401-411
Pig-a mutation: kinetics in rat erythrocytes following exposure to five prototypical mutagens

S. Phonethepswath1, D. Franklin1, D.K. Torous1, S.M. Bryce1, J.C. Bemis1, S. Raja1, S. Avlasevich1, P. Weller1, O. Hyrien2, J. Palis2, J.T. MacGregor3, S.D. Dertinger1

1 Litron Laboratories
2 University of Rochester Medical Center
3 Toxicology Consulting Services

Toxicological Sciences
Volume 114, Issue 1, March 2010, Pages 59-70
Erythrocyte-based Pig-a gene mutation assay: demonstration of cross-species potential

S. Phonethepswath, S.M. Bryce, J.C. Bemis, S.D. Dertinger

Litron Laboratories

Mutation Research/Genetic Toxicology and Environmental Mutagenesis
Volume 657, Issue 2, 8 December 2008, Pages 122–126
In vivo mutation assay based on the endogenous Pig-a locus

S.M. Bryce, J.C. Bemis, S.D. Dertinger

Litron Laboratories

Environmental and Molecular Mutagenesis
Volume 49, Issue 4, May 2008, Pages 256–264