EndoPredict breast cancer testing

A Second Generation Breast Cancer Gene Expression Test Performed in Your Local Laboratory

EndoPredict® in Your Local Laboratory

EndoPredict is available as a service performed by Myriad Genetics and as a CE-IVD kit that can be run in local molecular pathology laboratories after a comprehensive onsite training.

This  enables the pathologist to provide results within 24 hours. Treatment decisions can be made quickly and safely for maximized patient benefit.

EndoPredict has been validated in three analytical platforms: The VERSANT® kPCR Molecular System Amplification / Detection (AD) module, the QuantStudio™ Dx Real-Time PCR Instrument as well as the QuantStudio™ 5 Dx Real-Time PCR Instrument.

A unique prognostic test for prostate cancer will soon be available on the QuantStudio platforms as well.

VERSANT® is a registered trademark of Siemens Healthcare Diagnostics.
QuantStudio™ is a registered trademark of Thermo Fisher Scientific.

One Test
Three Clinical Answers for Breast Cancer Patients

EndoPredict is the ONLY
predictive and prognostic
test to answer
three critical clinical questions…

Can
chemotherapy
be avoided?

Risk at 10 years

What is the absolute
benefit from
chemotherapy?

Chemotherapy benefit

Can endocrine
therapy be stopped
after 5 years?

Risk up to 15 years

Can
chemotherapy be avoided?

Risk at 10 years1

What is the absolute benefit from chemotherapy?

Chemotherapy benefit2

Can endocrine therapy be stopped after 5 years?

Risk up to 15 years3

… to optimize treatment for N0/N+ breast cancer patients of each age

Less
Chemotherapy
Optimal
Treatment
Long Term
Confidence

EndoPredict is a gene expression assay for patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) early stage breast cancer who are lymph node negative or positive (N0, N1, micrometastases).

This second generation test combines a 12-Gene Molecular Score with tumor size and nodal status to provide more prognostic power than any other test.

EndoPredict Provides Superior Prognostic Performance – Results you can Trust

  • Identifies the most women with breast cancer at true low risk in head-to-head comparison with competitors.
  • Leads to a significant impact on therapy decision to give the right therapy to the right patient.
  • Predicts individualized absolute chemotherapy benefit for confident treatment decisions.
  • Provides 10 year and up to 15 year risk prediction for long term confidence.
  • Offers definitive risk classification in low or high risk.
  • Delivers fast result by local testing.

EndoPredict provides an individualized test result for each patient that allows for a quick, easy to understand risk assessment that can help deciding whether to safely forego chemotherapy or extended endocrine therapy.

Filipits M. et al.: A New Molecular Predictor of Distant Recurrence in ER-Positive, HER2-Negative Breast Cancer Adds Independent Information to Conventional Clinical Risk Factors. Clin Cancer Res. 2011;17(18):6012-6020
Sestak I. et al.: Prediction of Chemotherapy Benefit by EndoPredict in Patients with Breast Cancer Who Received Adjuvant Endocrine Therapy Plus Chemotherapy or Endocrine Therapy Alone. Breast Cancer Res Treat. 2019;176:377-386
Filipits M. et al.: Prediction of Distant Recurrence using EndoPredict among Women with ER+, HER2- Node-Positive and Node-Negative Breast Cancer Treated with Endocrine Therapy Only. Clin Cancer Res. 2019;25:3865-3872
Buus R. et al.: Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016 Jul 10;108(11)
Sestak I. et al.: Comparison of the Performance of 6 Prognostic Signatures for Estrogen Receptor-Positive Breast Cancer. A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018;4(4):545-553
Muller B. M. et al.: The EndoPredict Gene-Expression Assay in Clinical Practice – Performance and Impact on Clinical Decisions. PloSONE. 2013;8(6):e68252
Penault-Llorca F. et al.: Decision of adjuvant chemotherapy in intermediate risk luminal breast cancer patients: A prospective multicenter trial assessing the clinical and psychological impact of EndoPredict® (EPclin) use (UCBG 2-14). Breast. 2020;49:132-140
Ettl J. et al.: Decision Impact and feasibility of different ASCO-recommended biomarkers in early breast cancer: Prospective comparison of molecular marker EndoPredict and protein marker UPA/PAI-1. PLoSONE. 2017;12(9):e0183917

Test Procedure

EndoPredict is performed on FFPE tumor sections with a 30% tumor tissue ratio. If the ratio is lower, macrodissection is necessary. A 10µm tissue slide is required, material from a needle biopsy is sufficient.

After paraffin removal and lysis, nucleic acids are bound and purified through adsorption to magnetic beads, and co-purified DNA is removed. 

Reverse transcription is performed, followed by quantitative PCR. The EndoPredict kit provides 96-well PCR plates that contain primers and probes:

  • for the quantification of the RNA amounts from eight informative, breast cancer-related genes (AZGP1, BIRC5, DHCR7, IL6ST, MGP, RBBP8, STC2, UBE2C)
  • for the quantification of three reference genes (CALM2, OAZ1, RPL37A)
  • for the amplification of the HBB gene, a DNA-specific assay which is used for detection of residual genomic DNA.

The PCR occurs in 1.25 to 1.5 hours, depending on the platform.

Are you interested in performing EndoPredict in your Laboratory?

Please contact info@myriadgenetics.eu

Please contact: info@myriadgenetics.eu 

Result Report Generator

To generate the reports from the expression levels of the eight disease-relevant genes and four reference and normalization genes in the tumor sample, an export file from the PCR-platform is uploaded to the EndoPredict Report Generator (EPRG).

For a complete result report, tumor related information (tumor size and nodal status) is also indicated. The final results are calculated online by the EPRG Software. For secure data transmission, the website uses an Extended Validation SSL certificate.

Performing Laboratories

EndoPredict is available in several countries. The tumor sample can be sent:

  • Either to Myriad’s central laboratory in Salt Lake City, USA
  • Or to one of the centers worldwide that perform the test. Please check the list below to find our partner laboratories in your country.

List of available centers

Institut für Pathologie der Medizinischen Universität Graz

Ao. Univ.-Prof. Dr. med. Univ. Peter Regitnig
Neue Stiftingtalstraße 6
A-8036 Graz

Austria

www.pathologie.medunigraz.at

Telefon: +43 316 385 71764
Telefax: +43 316 385 79000
E-Mail: pathologie@medunigraz.at

 

Institut für klinische Pathologie und Molekularpathologie
Krankenhaus der Barmherzigen Schwestern Linz

Herr Univ. Prof. Dr. Farid Moinfar
Seilerstätte 4
A-4010 Linz

Austria

www.ordensklinikum.at/de/patienten/abteilungen/Pathologie/

Telefon: +43 732 7677 7354

 

Pathologielabor Dres. Obrist/Brunhuber OG, Zams

Dr. Peter Obrist
Auer Aloisia
Klostergasse 1
A- 6511 Zams

Austria

www.tyrolpath.at

Telefon: +43 5442 666110
Telefax: +43 5442 6661111
E-Mail: info@tyrolpath.at

Clinical and Molecular Pathology Lab. – MC TRANSHELIX Ltd.

Dr. Ani Petrova

1 Andrei Saharov blvd.
1784 Sofia

Tel.: +359 (0)2 4262032
Mobile.: +359 (0)889 431027

E-mail: info@transhelix.com

Centre Antoine Lacassagne

Dr Juliette Haudebourg

33, avenue de Valombrose
06189 Nice Cedex 2

Tél. : 04 92 03 11 34

 

Centre Eugène Marquis

Dr Véronique Quillien

Rue de la Bataille Flandres Dunkerque
CS 44229
35042 Rennes Cedex

Tél. : 02 99 25 30 00
E-mail : v.quillien@rennes.unicancer.fr

 

Centre Georges-François Leclerc (CGFL)

Dr Laurent Arnould, MD, PhD

Département de Biologie et de Pathologie des Tumeurs
1, rue Professeur Marion
BP 77079
21079 Dijon Cedex

Tél. : 03 80 73 75 14
Fax : 03 80 73 77 26
E-mail : larnould@cgfl.fr

 

Centre Jean Perrin

58, rue Montalembert
B.P. 392
63001 Clermont-Ferrand Cedex 01

Tél. : 04 73 27 80 80

 

Centre de Pathologie du Maine-Normandie

Dr Norbert Padilla

45, rue du Chanoine Julien Lelièvre
72000 Le Mans

Tél. : 02 43 14 15 00

Cerba

Dr Raouf Ben Abdelali

Z.I. Les Béthunes

7/11, rue de l’Equerre
95310 Saint-Ouen-l’Aumône

Tél. : 01 34 40 20 20
E-mail : src@lab-cerba.com

 

CHRU Tours – Hôpital Trousseau

Dr Anne Tallet, Mme Christine Collin
Plateforme de Génétique Moléculaire des Cancers

Avenue de la République
37170 Chambray-lès-Tours

Tél. : Dr Anne Tallet : 02 47 47 47 47 (poste 7-1462), Mme Christine Collin : 02 47 47 81 18
E-mail : anne.tallet@univ-tours.fr, Christine.collin@univ-tours.fr

 

CHU de Poitiers

Pr Lucie Karayan-Tapon

2, rue de la Milétrie
86021 Poitiers

Tél. : 05 49 44 44 44

 

Cypath Lyon

Dr Marie-Pierre Wissler

201, route de Genas
69100 Villeurbanne

Tél. : 04 78 69 38 99

 

Hôpital Saint-Louis

Dr Jacqueline Lehmann-Che

1, avenue Claude Vellefaux
75010 Paris

Tél. : 01 42 49 49 49

 

Imagenome

Dr Pierre-Jean Lamy

6, rue Fontenille
34000 Montpellier

Tél. : 04 30 05 31 00
E-mail : imagenome@labosud.fr

 

Institut Bergonié

Dr Soubeyran

229, cours de l’Argonne
CS 61283
33076 Bordeaux Cedex

Tél.: 05 56 33 33 33

 

Institut de Cancérologie de l’Ouest (ICO)
René Gauducheau

Dr Mathilde Dupe

Boulevard du Professeur Jacques Monod
44805 Saint-Herblain

Tél. : 02 40 67 98 37

 

Institut Gustave Roussy

Dr Ludovic Lacroix
Dr Magali Lacroix-Triki

114, rue Edouard Vaillant
94805 Villejuif Cedex

Tél. : 01 42 11 44 55
E-mail : magali.lacroix-Triki@gustaveroussy.fr

 

Institut de Pathologie de Paris

Dr Linda Dainese

35, boulevard de Stalingrad
92240 Malakoff

Tél. : 01 55 64 18 80
E-mail : ld@inpath.fr

 

Medipath

Madame Sophie Manz
Madame Magali Guernion
165, rue de Corindon

13510 Eguilles

Tél. : Dr Sophie Manz : 07 72 01 18 68, Mme Magali Guernion : 06 82 67 24 21
E-mail : smanz@medipath.fr, m.guernion@medipath.fr

 

Mont-Blanc Pathologie

Dr Thierry Cruel
40, route de l’Aiglière

CS 60082
74372 Pringy Cedex

Tél. : 04 50 45 05 91

Institut für Pathologie; Charité Campus Mitte

Charité – Universitätsmedizin Berlin
Prof. Dr. med. Carsten Denkert
Charitéplatz 1
10117 Berlin

Germany

http://pathologie-ccm.charite.de

Tel. : +49 (0)30 450 536 047
Fax: +49 (0)30 450 536 902
E-mail: carsten.denkert@charite.de

 

Pathologisches Institut Celle

PD Dr. med. Peer Flemming
Prof. Dr. med. Axel Wellmann
Wittinger Str. 14
29223 Celle

Germany

http://www.pathologen.net

Telefon: +49 (0)5141 721650
Telefax: +49 (0)5141 721659
E-Mail: info@pathologen.net

 

Institut für Pathologie und Molekularpathologie

Dr. med. Gudrun Schlake
Rotthauserstr. 23
45879 Gelsenkirchen

Germany

www.pathologie-gelsenkirchen.de/

Telefon: +49 (0)209 158070
Telefax: +49 (0)209 1580743
E-Mail: info@pathoge.de

 

Universitätsklinikum Hamburg-Eppendorf, Institut für Pathologie

Prof. Dr. med. Guido Sauter
PD Dr. med. Eike-C. Buradt
Martinistr. 52
20246 Hamburg

Germany

https://www.uke.de/kliniken-institute/pathologie-mit-sektionen-molekularpathologie-und-zytopathologie/team/mitarbeiterverzeichnis_patho.html

Telefon: +49 (0)40 7410 55500
Telefax: +49 (0)40 7410 56815
E-Mail: g.sauter@uke.de

 

Praxis für Pathologie

am KRH Klinikum Nordstadt
Prof. Dr. med. Ludwig Wilkens
Haltenhoffstr. 41
30167 Hannover

Germany

http://www.krh.eu/klinikum/NSK/kliniken/pathologie

Tel.: +49 (0)511 970 14 29
Fax: +49 (0)511 970 16 49
E-mail: ludwig.wilkens@krh.eu

 

Institut für Pathologie Hildesheim-Goslar

am St. Bernward Krankenhaus
Prof Dr. med. Karl-Friedrich Bürrig
Treibestraße 9
31134 Hildesheim

Germany

www.bernward-khs.de/content/institut-pathologie

Telefon: +49 (0)5121 17467-0
Telefax: +49 (05121 17467-116
E-Mail: sekretariat@ifp-hi.de

 

Institut für Allgemeine Pathologie und Pathologische Anatomie der Technischen Universität München

Prof. Dr. Wilko Weichert
Trogerstraße 18
81675 München

Germany

www.path.med.tum.de

Tel.: +49 (0)89 41404161
Fax: +49 (0)89 41404865
E-mail: Sekretariat.path.med@tum.de

 

Universität Regensburg, Institut für Pathologie

Prof. Dr. med. Matthias Evert
Franz-Josef-Strauß-Allee 11
93053 Regensburg

Germany

www.pathologie-regensburg.de

Tel.: +49 (0)941 944 66 01
Fax: +49 (0)941 944 66 02
E-mail: info@pathologie-regensburg.de

 

Molekularpathologie Trier

Prof. Dr. med. Dr. phil. Jörg Kriegsmann
PD. Dr. med. habil. Dipl.-Med. Mike Otto
Carolin Altmann
Max-Planck-Straße 17
54296 Trier

Germany

www.molekularpatho-trier.de/

Telefon: +49 (0)651 1461830
Telefax: +49 (0)651 14618323
E-Mail: labor@molekularpatho-trier.de

BIOIATRIKI S.A.

Dr Irene Louizou
Molecular and Cytogenetics Department
132 Kifissias Ave. & Papada str.
115 26, Athens
Greece

Tel.: +30 210 6966130

Contact names:

– Dr Irene Louizou (molecular@bioiatriki.gr, Tel.: +30 210 6966130)
– Theodoros Nikolaidis (tnikolaidis@geneanalysis.eu, Tel.: +30 2311 211686, geneanalysis.eu)

ANDRIA (BAT) – Presidio Ospedaliero “L. Bonomo”- Unità Operativa di Anatomia Patologica

Dr.ssa Rosanna Nenna

Viale Istria, 1

70031 Andria (BT)

Italy

Tel.: +39 0883299192

E-mail: rosannanenna@gmail.com

 

BARI – IRCCS Istituto Tumori “Giovanni Paolo II” – SSD Diagnostica Molecolare e Farmacogenetica

Dr.ssa Brunella Pilato / Dr.ssa Stefania Tommasi

v.le Orazio Flacco, 65

70124 Bari

Italy

Tel. +39 0805555264

E-mail: s.tommasi@oncologico.bari.it

 

CAGLIARI – Azienda Ospedaliera “Brotzu” – Anatomia Patologica

Dott.ssa Sandra Orrù

Via Edward Jenner, 1

09121 Cagliari

Italy

Tel.: +39 07052965417

E-mail: sandra.orru@aob.it

 

MILANO – Fondazione IRCCS Istituto Nazionale dei Tumori – Dip. Patologia Diagnostica e Laboratorio

Dr.ssa Annunziata Gloghini/ Prof. Giancarlo Pruneri 

Via G. Venezian, 1

20133 Milano

Italy

Tel.: +39 0223902227

E-mail: annunziata.gloghini@istitutotumori.mi.it

 

NOVARA – A.O.U. “Maggiore della Carità”– Anatomia Patologica

Prof. Renzo Boldorini

Corso Mazzini, 18

28100 Novara

Italy

Tel.: +39 03213733374

E-mail: anatomiapat.dir@maggioreosp.novara.it

 

PAVIA – Fondazione “S.Maugeri”, Istituto di Pavia – Chir. Senologica e Chir. Plastica Oncologica

Dr.ssa Alessia De Simone

Via Salvatore Maugeri, 10

27100 Pavia

Italy

Tel.: +39 0382592277

E-mail: alessia.desimone@fsm.it

PERUGIA – Azienda Ospedaliero-Universitaria- S.C. di Anatomia e Istologia Patologica

Prof. Angelo Sidoni

P.le Menghini, 1

06129 Perugia

Italy

Tel.: +39 0755783927

E-mail: angelo.sidoni@unipg.it

 

TORINO – A.O.U. Citta della Salute e della Scienza – Anatomia Patologica

Dr.ssa Isabella Castellano

Via Santena, 7

10126 Torino

Italy

Tel.: +39 0116334432

E-mail: isabella.castellano@unito.it

Patiacan

Dr. Jessica Otero
Medical Director

Corporativo Antara I, Piso 5, Av. Ejercito Nacional, 843-B

Col. Granada, Miguel Hidalgo, C.P. 11520, Ciudad de Mexico
Mexico

Tel.: +52 (55) 8000 1916 (ext.: 8983)

E-mail: jessica.otero@patia.com.mx
Grupo Diagnostico: grupodiagnostico.com

 

Hospital Universitario La Paz, IdiPAZ

Dr. David Hardisson

Servicio de Anatomía Patológica ,1ª Planta, Ed. Consultas
Externas de Maternidad

Paseo de la Castellana, 261
28046 Madrid

Telefon: +34 917 277 300

E-Mail: david.hardisson@salud.madrid.org

 

Hospital Universitario de Canárias

Dr.Eduardo Salido

Departamento de Anatomia Patologica

Carretera de Ofra, s/n
38320 Tenerife  – San Cristóbal De La Laguna

Telefon: +34 922 679 731

E-Mail: esalido@ull.es

Institut für Histologische und Zytologische Diagnostik

Dr. med. Steffen Bergelt

Dammweg 1
5000 Aarau
Switzerland

Tel.: +41 (0)62 834 0280
E-mail: institut@patho-diagnostik.ch

Institut für Pathologie/Labormedizin

Prof. Dr. med. Paul Komminoth

Birmensdorferstrasse 497
8063 Zurich
Switzerland

Tel.: +41 (0)44 416 53 00
E-mail: paul.komminoth@triemli.zuerich.ch

Institute of Pathology, Locarno

Prof. Dr. med. Luca Mazzucchelli

Via In Selva 24
6600 Locarno
Switzerland

Tel.: +41 (0)91 816 08 05
Fax: +41 (0)91 816 07 19
E-mail: luca.mazzucchelli@ti.ch

 

Kantonsspital Baden, Institut für Pathologie

Prof. Dr. med. Gad Singer

Im Ergel
5404 Baden
Switzerland

Tel.: +41 (0)56 486 39 02
E-mail: gad.singer@ksb.ch

 

Pathologie Länggasse, Ittigen

PD Dr. med. Meike Körner

Worblentalstrasse 32
3063 Ittigen
Switzerland

Tel.: +41 (0)31 300 24 24
Fax: +41 (0)31 300 24 20
E-mail: info@patholaenggasse.ch

 

Pathologie Luzerner Kantonsspital

Prof. Dr. med. Joachim Diebold

Spitalstrasse
6000 Luzern 16
Switzerland

Tel.: +41 (0)41 205 34 71
E-mail: pathologie@luks.ch

Sarah Cannon Molecular Diagnostics

Part of HCA Healthcare UK

Ground Floor
Shropshire House

1 Capper Street
London, WC1E 6JA
United Kingdom

www.sarahcannon-md.co.uk

Tel.: +44 (0)20 3794 1920
Fax: +44 (0)20 3794 1921
E-mail: info@sarahcannon-md.co.uk

 

Source BioScience

1 Orchard Place
Nottingham Business Park

Nottingham
NG8 6PX
United Kingdom

Tel.: +44 (0)115 973 9012
E-mail: enquiries@sourcebioscience.com