Research & Development Programmes

In house bioanalytical R&D services focused on development of novel diagnostic and therapeutic intervention strategies targeting the cell cycle machinery.

Theranostic patient-centered strategies are often directed against complex and redundant growth signalling networks from surface ligands and receptors through transducers to downstream effector molecules.

However the redundancy of these networks can result in low efficacy of molecularly targeted drugs and constraints on the performance of cancer biomarkers directed at these pathways.

Oncologica’s alternative genetic testing approach is to target the cell cycle machinery, which acts as a convergence point for information transduced through upstream signalling networks and therefore represents an exceptionally attractive diagnostic and therapeutic target.

Research Papers

Utilisation of semiconductor sequencing for the detection of predictive biomarkers in glioblastoma

Utilisation of semiconductor sequencing for the detection of predictive biomarkers in glioblastoma

Published: March 25, 2022 DOI: https://doi.org/10.1371/journal.pone.0245817

Gareth H Williams, Alexander Llewelyn, Robert Thatcher, Keeda-Marie Hardisty, Marco Loddo

SARS-CoV-2 testing and sequencing for international arrivals reveals significant cross border transmission of high risk variants into the United Kingdom

SARS-CoV-2 testing and sequencing for international arrivals reveals significant cross border transmission of high risk variants into the United Kingdom

EClinical Medicine by the Lancet Published:July 14, 2021 DOI: https://doi.org/10.1016/j.eclinm.2021.101021

Gareth H Williams, Alexander Llewelyn, Ruben Brandao, Kaiya Chowdhary,Keeda-Marie Hardisty, Marco Loddo (2021)

Clinical, Radiometabolic and Immunologic Effects of Olaparib in Locally Advanced Triple Negative Breast Cancer: The OLTRE Window of Opportunity Trial

Clinical, Radiometabolic and Immunologic Effects of Olaparib in Locally Advanced Triple Negative Breast Cancer: The OLTRE Window of Opportunity Trial

Front Oncol. 2021; 11: 686776. Published online 2021 Jun 28. doi: https://doi.org/10.3389/fonc.2021.686776

Alfredo Molteni, Alice Bruson, Carla Strina, Carlo Azzini, Daniele Generali, Davide Cerra, Elena Marasco, Elisa Zago, Fabiola Giudici, Francesco Schettini, Gareth H Williams, Giovanni Scambia, Giuseppina Barbieri, Giuseppina Ferrero, Ida Paris, Luciano Xumerle, Manuela Milani, Marco Loddo, Marco Ungari, Maria Chiara Lazzari, Maria Rosa Cappelletti, Marianna Sirico, Nicoletta Ziglioli, Ottavia Bernocchi, Sergio Aguggini, Silvia Paola Corona, Valeria Cervoni

The actionable genomic mutational landscape in solid tumours

The actionable genomic mutational landscape in solid tumours

J Clin Oncol 38: 2020 (suppl; abstr e13642) DOI: https://doi.org/10.1200/JCO.2020.38.15_suppl.e13642

Loddo M, Hardisty KM, Thatcher RP, Haddow TE, Williams GH (2020)

Immunofocus-PD-L1 high throughput quantitative next generation sequencing assay

Immunofocus-PD-L1 high throughput quantitative next generation sequencing assay

J Clin Oncol 38: 2020 (suppl; abstr e13521) DOI: https://doi.org/10.1200/JCO.2020.38.15_suppl.e13521

Williams GH, Thatcher RP, Haddow TE, Hardisty KM, Loddo M (2020)

Druggable fusion gene landscape in solid tumors

Druggable fusion gene landscape in solid tumors

J Clin Oncol 38: 2020 (suppl; abstr e13517) DOI: https://doi.org/10.1200/JCO.2020.38.15_suppl.e13517

Williams GH, Thatcher RP, Nevado B, Haddow TE, Hardisty KM, Loddo M (2020)

Inter-observer Reliability of Programmed Cell Death Ligand-1 Scoring Using the VENTANA PD-L1 (SP263) Assay in Non-Small Cell Lung Cancer

Inter-observer Reliability of Programmed Cell Death Ligand-1 Scoring Using the VENTANA PD-L1 (SP263) Assay in Non-Small Cell Lung Cancer

J Thorac Oncol. 2019 Nov 25. pii: S1556-0864(19)33664-0. doi: https://doi.org/10.1016/j.jtho.2019.11.010.

Williams GH, Nicholson AG, Snead DRJ, Thunnissen E, Lantuejoul S, Cane P, Kerr KM, Loddo M, Scott MLJ, Scorer PW, Barker C. (2019)

Assessment of PD-L1 mRNA and protein expression in non-small cell lung cancer, head and neck squamous cell carcinoma and urothelial carcinoma tissue specimens using RNAScope and immunohistochemistry.

Assessment of PD-L1 mRNA and protein expression in non-small cell lung cancer, head and neck squamous cell carcinoma and urothelial carcinoma tissue specimens using RNAScope and immunohistochemistry.

PLoS ONE 14(4): e0215393

David Jonathan Duncan ,Marietta Scott,Paul Scorer et al ()

Mapping the binding sites of antibodies utilized in programmed cell death ligand-1 predictive immunohistochemical assays for use with immuno-oncology therapies

Mapping the binding sites of antibodies utilized in programmed cell death ligand-1 predictive immunohistochemical assays for use with immuno-oncology therapies

Mod Pathol. 2019 Sep 26. doi: https://doi.org/10.1038/s41379-019-0372-z. [Epub ahead of print] Erratum in: Mod Pathol. 2019 Oct

Lawson NL, Dix CI, Scorer PW, Stubbs CJ, Wong E, Hutchinson L, McCall EJ, Schimpl M, DeVries E, Walker J, Williams GH, Hunt J, Barker C. (2019)

Immunophenotypic analysis of cell cycle status in acute myeloid leukaemia: relationship to cytogenetics, genotype and clinical outcome

Immunophenotypic analysis of cell cycle status in acute myeloid leukaemia: relationship to cytogenetics, genotype and clinical outcome

Br J Haematol. 2018 May;181(4):486-494. doi: https://doi.org/10.1111/bjh.15211. Epub 2018 Apr 20.

Sellar RS, Gale RE, Khwaja A, Garbowski M, Loddo M, Stoeber K, Williams GH, Linch DC

DNA replication licensing factor MCM2, geminin, and Ki67 define proliferative state and are linked with survival in oral squamous cell carcinoma

DNA replication licensing factor MCM2, geminin, and Ki67 define proliferative state and are linked with survival in oral squamous cell carcinoma

Eur J Oral Sci. 2018 Jun;126(3):186-196. doi: https://doi.org/10.1111/eos.12420.

Al-Hazmi N, Alhazzazi T, Williams G, Stoeber K, Al-Dabbagh R

Consistency of tumor and immune cell programmed cell death ligand-1 expression within and between tumor blocks using the VENTANA SP263 assay

Consistency of tumor and immune cell programmed cell death ligand-1 expression within and between tumor blocks using the VENTANA SP263 assay

Diagnostic Pathology, (2018) 13:47 DOI: https://doi.org/10.1186/s13000-018-0725-9

Paul Scorer, Marietta Scott, Nicola Lawson et al (2018)

Agreement between Programmed Cell Death Ligand-1 Diagnostic Assays across Multiple Protein Expression Cut-Offs in Non-Small Cell Lung Cancer

Agreement between Programmed Cell Death Ligand-1 Diagnostic Assays across Multiple Protein Expression Cut-Offs in Non-Small Cell Lung Cancer

Clinical Cancer Research, January 2017; 16-2375 DOI: https://doi.org/10.1158/1078-0432.ccr-16-2375

Marianne J Ratcliffe, Alan Sharpe, Anita Midha et al (2017)

A novel p53-Cdc7 link induced by genotoxic stress

A novel p53-Cdc7 link induced by genotoxic stress

Cell Cycle, DOI: https://doi.org/10.1080/15384101.2017.1304746.

Hisao Masai

Relevance of deep learning to facilitate the diagnosis of HER2 status in breast cancer.

Relevance of deep learning to facilitate the diagnosis of HER2 status in breast cancer.

Nature – Scientific Reports, April 2017, 7, 45938 DOI: https://doi.org/10.1038/srep45938

Michel E. Vandenberghe, Marietta L. J. Scott, Paul W. Scorer et al (2017)

Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL

Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL

Virchows Arch (2016). doi: https://doi.org/10.1007/s00428-016-2025-7.

Zandra C Deans, Jose Luis Costa, Ian Cree, Els Dequeker, Anders Edsjö, Shirley Henderson, Michael Hummel, Marjolijn JL Ligtenberg, Marco Loddo, Jose Carlos Machado, Antonio Marchetti, Katherine Marquis, Joanne Mason, Nicola Normanno, Etienne Rouleau, Ed Schuuring, Keeda-Marie Snelson, Erik Thunnissen, Bastiaan Tops, Gareth Williams, Han van Krieken, Jacqueline A Hall, On behalf of IQN Path ASBL

A comparative study of PD-L1 diagnostic assays in squamous cell carcinoma of the head and neck (SCCHN)

A comparative study of PD-L1 diagnostic assays in squamous cell carcinoma of the head and neck (SCCHN)

Annals of Oncology; 27 (suppl_6): 955PD DOI: https://doi.org/10.1093/annonc/mdw376.07

J. Ratcliffe, A. Sharpe, M. Rebelatto et al ()

p53 controls CDC7 levels to reinforce G1 cell cycle arrest upon genotoxic stress

p53 controls CDC7 levels to reinforce G1 cell cycle arrest upon genotoxic stress

Cell Cycle. 2016 Sep 9:0 DOI: https://doi.org/10.1080/15384101.2016.1231281

Tudzarova S, Mulholland P, Dey A, Stoeber K, Okorokov AL, Williams GH

Cell cycle status in AML blast cells from peripheral blood, bone marrow aspirates and trephines and implications for biological studies and treatment

Cell cycle status in AML blast cells from peripheral blood, bone marrow aspirates and trephines and implications for biological studies and treatment

Br J Haematol. 2016 Apr 8. doi: https://doi.org/10.1111/bjh.14055

Sellar RS, Fraser L, Khwaja A, Gale RE, Marafioti T, Akarca A, Hubank M, Brooks T, Stoeber K,Williams G, Linch DC

Cdc7 is a potent anti-cancer target in pancreatic cancer due to abrogation of the DNA origin activation checkpoint

Cdc7 is a potent anti-cancer target in pancreatic cancer due to abrogation of the DNA origin activation checkpoint

Oncotarget. 2016 Feb 23. doi: https://doi.org/10.18632/oncotarget.7611.

Huggett MT, Tudzarova S, Proctor I, Loddo M, Keane MG, Stoeber K, Williams GH, Pereira SP.

Do Cell-Cycle Phase-Specific Markers Predict Disease Grade, Stage, and Outcome in Cervical Carcinoma?

Do Cell-Cycle Phase-Specific Markers Predict Disease Grade, Stage, and Outcome in Cervical Carcinoma?

Int J Gynecol Cancer. 2015 Jul;25(6):1066-72.

Kuku S, Proctor I, Loddo M, Kadalayil L, KhoshZaban M, Ledermann J, McCormack M.

Pregnancy-associated plasma protein A regulates mitosis and is epigenetically silenced in breast cancer

Pregnancy-associated plasma protein A regulates mitosis and is epigenetically silenced in breast cancer

J Pathol. 2014 Aug;233(4):344-56.

Loddo M, Andryszkiewicz J, Rodriguez-Acebes S, Stoeber K, Jones A, Dafou D, Apostolidou S, Wollenschlaeger A, Widschwendter M, Sainsbury R, Tudzarova S, Williams GH.

Subcellular proteomics reveals a role for nucleo-cytoplasmic trafficking at the DNA replication origin activation checkpoint

Subcellular proteomics reveals a role for nucleo-cytoplasmic trafficking at the DNA replication origin activation checkpoint

J Proteome Res. 2013 Mar 1;12(3):1436-53

Mulvey CM, Tudzarova S, Crawford M, Williams GH, Stoeber K, Godovac-Zimmermann J

Bladder cancer diagnosis and identification of clinically significant disease by combined urinary detection of Mcm5 and nuclear matrix protein 22

Bladder cancer diagnosis and identification of clinically significant disease by combined urinary detection of Mcm5 and nuclear matrix protein 22

PLoS One. 2012;7(7):e40305

Kelly JD, Dudderidge TJ, Wollenschlaeger A, Okoturo O, Burling K, Tulloch F, Halsall I, Prevost T, Prevost AT, Vasconcelos JC, Robson W, Leung HY, Vasdev N, Pickard RS, Williams GH, Stoeber K.

The cell cycle and cancer

The cell cycle and cancer

J Pathol. 2012 Jan;226(2):352-64.

Williams GH, Stoeber K.

Exploring the interaction between siRNA and the SMoC biomolecule transporters: implications for small molecule-mediated delivery of siRNA

Exploring the interaction between siRNA and the SMoC biomolecule transporters: implications for small molecule-mediated delivery of siRNA

Chem Biol Drug Des. 2012 Jan;79(1):9-21.

Gooding M, Tudzarova S, Worthington RJ, Kingsbury SR, Rebstock AS, Dube H, Simone MI, Visintin C, Lagos D, Quesada JM, Laman H, Boshoff C, Williams GH, Stoeber K, Selwood DL.

Molecular architecture of the DNA replication origin activation checkpoint

Molecular architecture of the DNA replication origin activation checkpoint

EMBO J. 2010 Oct 6;29(19):3381-94.

Tudzarova S, Trotter MW, Wollenschlaeger A, Mulvey C, Godovac-Zimmermann J, Williams GH, Stoeber K.

Two ubiquitin ligases, APC/C-Cdh1 and SKP1-CUL1-F (SCF)-beta-TrCP, sequentially regulate glycolysis during the cell cycle

Two ubiquitin ligases, APC/C-Cdh1 and SKP1-CUL1-F (SCF)-beta-TrCP, sequentially regulate glycolysis during the cell cycle

Proc Natl Acad Sci U S A. 2011 Mar 29;108(13):5278-83.

Tudzarova S, Colombo SL, Stoeber K, Carcamo S, Williams GH, Moncada S.

Targeting DNA replication before it starts: Cdc7 as a therapeutic target in p53-mutant breast cancers

Targeting DNA replication before it starts: Cdc7 as a therapeutic target in p53-mutant breast cancers

Am J Pathol. 2010 Oct;177(4):2034-45.

Rodriguez-Acebes S, Proctor I, Loddo M, Wollenschlaeger A, Rashid M, Falzon M, Prevost AT, Sainsbury R, Stoeber K, Williams GH.

Diagnosis of prostate cancer by detection of minichromosome maintenance 5 protein in urine sediments

Diagnosis of prostate cancer by detection of minichromosome maintenance 5 protein in urine sediments

Br J Cancer. 2010 Aug 24;103(5):701-7.

Dudderidge TJ, Kelly JD, Wollenschlaeger A, Okoturo O, Prevost T, Robson W, Leung HY, Williams GH, Stoeber K.

Standard Reference Material: Cell Line Development and Use of Reference Cell Lines as Standards for External Quality Assurance of Her2 IHC and ISH Testing. Antigen Retrieval Immunohistochemistry Based Research and Diagnostics (Book)

Standard Reference Material: Cell Line Development and Use of Reference Cell Lines as Standards for External Quality Assurance of Her2 IHC and ISH Testing. Antigen Retrieval Immunohistochemistry Based Research and Diagnostics (Book)

First Edition; 2010; Chapter 6; pp.101-122 DOI: https://doi.org/10.1002/9780470875612.ch6

Shan-Rong Shi and Clive R. Taylor (2010)

DNA replication licensing factors and aneuploidy are linked to tumor cell cycle state and clinical outcome in penile carcinoma

DNA replication licensing factors and aneuploidy are linked to tumor cell cycle state and clinical outcome in penile carcinoma

Clin Cancer Res. 2009 Dec 1;15(23):7335-44.

Kayes OJ, Loddo M, Patel N, Patel P, Minhas S, Ambler G, Freeman A, Wollenschlaeger A, Ralph DJ, Stoeber K, Williams GH.

Cdc7 kinase is a predictor of survival and a novel therapeutic target in epithelial ovarian carcinoma

Cdc7 kinase is a predictor of survival and a novel therapeutic target in epithelial ovarian carcinoma

Clin Cancer Res. 2009 Apr 1;15(7):2417-25.

Kulkarni AA, Kingsbury SR, Tudzarova S, Hong HK, Loddo M, Rashid M, Rodriguez-Acebes S, Prevost AT, Ledermann JA, Stoeber K, Williams GH.

Phospho-STAT5 and phospho-Akt expression in chronic myeloproliferative neoplasms

Phospho-STAT5 and phospho-Akt expression in chronic myeloproliferative neoplasms

British Journal of Haematology, 2009, Vol. 147: p495-506 DOI: https://doi.org/10.1111/j.1365-2141.2009.07870.x

L. F. Grimwade, L. Happerfield, C. Tristram Lisa Happerfield et al (2009)

Cell-cycle-phase progression analysis identifies unique phenotypes of major prognostic and predictive significance in breast cancer

Cell-cycle-phase progression analysis identifies unique phenotypes of major prognostic and predictive significance in breast cancer

Br J Cancer. 2009 Mar 24;100(6):959-70.

Loddo M, Kingsbury SR, Rashid M, Proctor I, Holt C, Young J, El-Sheikh S, Falzon M, Eward KL, Prevost T, Sainsbury R, Stoeber K, Williams GH.

Modular assembly using sequential palladium coupling gives easy access to the SMoC class of cellular transporters

Modular assembly using sequential palladium coupling gives easy access to the SMoC class of cellular transporters

Chembiochem. 2008 Jul 21;9(11):1787-96.

Rebstock AS, Visintin C, Leo E, Garcia Posada C, Kingsbury SR, Williams GH, Stoeber K, Selwood DL.

Diagnosis of pancreaticobiliary malignancy by detection of minichromosome maintenance protein 5 in bile aspirates

Diagnosis of pancreaticobiliary malignancy by detection of minichromosome maintenance protein 5 in bile aspirates

Br J Cancer. 2008 May 6;98(9):1548-54.

Ayaru L, Stoeber K, Webster GJ, Hatfield AR, Wollenschlaeger A, Okoturo O, Rashid M, Williams G, Pereira SP.

Identification of an arginine-rich motif in human papillomavirus type 1 E1;E4 protein necessary for E4-mediated inhibition of cellular DNA synthesis in vitro and in cells

Identification of an arginine-rich motif in human papillomavirus type 1 E1;E4 protein necessary for E4-mediated inhibition of cellular DNA synthesis in vitro and in cells

J Virol 82:9056-9064

Roberts S, Kingsbury SR, Stoeber K, Knight GL Gallimore PH & Williams GH

Cell cycle markers in clinical oncology

Cell cycle markers in clinical oncology

Curr Opin Cell Biol. 2007 Dec;19(6):672-9.

Williams GH, Stoeber K.

DNA replication licensing factors and aurora kinases are linked to aneuploidy and clinical outcome in epithelial ovarian carcinoma.

DNA replication licensing factors and aurora kinases are linked to aneuploidy and clinical outcome in epithelial ovarian carcinoma.

Clin Cancer Res. 2007 Oct 15;13(20):6153-61.

Kulkarni AA, Loddo M, Leo E, Rashid M, Eward KL, Fanshawe TR, Butcher J, Frost A, Ledermann JA, Williams GH, Stoeber K.

Hexameric ring structure of human MCM10 DNA replication factor

Hexameric ring structure of human MCM10 DNA replication factor

EMBO Rep. 2007 Oct;8(10):925-30.

Okorokov AL, Waugh A, Hodgkinson J, Murthy A, Hong HK, Leo E, Sherman MB, Stoeber K, Orlova EV, Williams GH.

Mitogenic growth signalling, DNA replication licensing, and survival are linked in prostate cancer

Mitogenic growth signalling, DNA replication licensing, and survival are linked in prostate cancer

Br J Cancer. 2007 May 7;96(9):1384-93.

Dudderidge TJ, McCracken SR, Loddo M, Fanshawe TR, Kelly JD, Neal DE, Leung HY, Williams GH, Stoeber K.

DNA replication licensing, and survival are linked in prostate cancer

DNA replication licensing, and survival are linked in prostate cancer

Br J Cancer. 2007 May 7;96(9):1384-93.

Dudderidge TJ, McCracken SR, Loddo M, Fanshawe TR, Kelly JD, Neal DE, Leung HY, Williams GH, Stoeber K.

Small-molecule mimics of an alpha-helix for efficient transport of proteins into cells

Small-molecule mimics of an alpha-helix for efficient transport of proteins into cells

Nat Methods. 2007 Feb;4(2):153-9.

Okuyama M, Laman H, Kingsbury SR, Visintin C, Leo E, Eward KL, Stoeber K, Boshoff C, Williams GH, Selwood DL.

Novel markers of cell kinetics to evaluate progression from cirrhosis to hepatocellular carcinoma

Novel markers of cell kinetics to evaluate progression from cirrhosis to hepatocellular carcinoma

Liver Int. 2006 May;26(4):424-32.

Quaglia A, McStay M, Stoeber K, Loddo M, Caplin M, Fanshawe T, Williams G, Dhillon A.

DNA replication licensing and cell cycle kinetics of normal and neoplastic breast

DNA replication licensing and cell cycle kinetics of normal and neoplastic breast

Br J Cancer. 2005 Nov 28;93(11):1295-300.

Shetty A, Loddo M, Fanshawe T, Prevost AT, Sainsbury R, Williams GH, Stoeber K.

Repression of DNA replication licensing in quiescence is independent of geminin and may define the cell cycle state of progenitor cells

Repression of DNA replication licensing in quiescence is independent of geminin and may define the cell cycle state of progenitor cells

Exp Cell Res. 2005 Sep 10;309(1):56-67.

Kingsbury SR, Loddo M, Fanshawe T, Obermann EC, Prevost AT, Stoeber K, Williams GH.

DNA replication licensing in peripheral B-cell lymphoma

DNA replication licensing in peripheral B-cell lymphoma

J Pathol. 2005 Feb;205(3):318-28.

Obermann EC, Eward KL, Dogan A, Paul EA, Loddo M, Munson P, Williams GH, Stoeber K.

Mcm2, Geminin, and KI67 define proliferative state and are prognostic markers in renal cell carcinoma

Mcm2, Geminin, and KI67 define proliferative state and are prognostic markers in renal cell carcinoma

Clin Cancer Res. 2005 Apr 1;11(7):2510-7.

Dudderidge TJ, Stoeber K, Loddo M, Atkinson G, Fanshawe T, Griffiths DF, Williams GH.

DNA replication licensing in somatic and germ cells

DNA replication licensing in somatic and germ cells

J Cell Sci. 2004 Nov 15;117(Pt 24):5875-86.

Eward KL, Obermann EC, Shreeram S, Loddo M, Fanshawe T, Williams C, Jung HI, Prevost AT, Blow JJ, Stoeber K, Williams GH.

Dr David Fenelly

MD FRCPI ESMO

Former: Consultant Medical Oncologyst St Vincent’s University Hospital (SVUH); St Luke’s Hospital, National Maternity Hospital; St. Vincent’s Private Hospital; and Blackrock Clinic, Dublin; Member of International Advisory Board of Oneview Ltd. and Oneview Healthcare PLC; Member Director Centre for Colorectal Disease of SVUH;

Member of American Society of Clinical Oncology, European Society of Medical Oncology and Irish Society of Medical Oncology; Fellow of Royal College of Physicians; Formerly: Member of Breast and Gynaecological Cancer; Post Graduate Training from Memorial Sloan Kettering Cancer Centre.

Prof Umberto Tirelli

MD

Former: Consultant Medical Oncologyst National Cancer Institute Aviano; Specialist in Oncology, Hematology and Infectious Diseases; “Commendatore” of the Italian Republic, awarded by the President of the Republic for scientific merit; co-founder and VP of the Associazione Scientifica Galileo 2001; Member of the Technical Scientific Board (CTS) at Centro di Riferimento Oncologico (CRO) in Aviano, Istituto Nazionale Tumori; Assigned to the Scientific Council of AIN (Associazione Italiana Nucleare) on nuclear power; Former President of AIMAC (Cancer Patients Italian Association) and now part of the Scientific Council;

Formerly appointed by the Italian Minister of Health as member of the National Oncology Commission; Member of the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), the American Society of Hematology (ASH),and the International Immune-compromised Host Society (IHS); Member of the Scientific Committee of the AIOTE (Italian Association of oncology of the elderly);

Task Force Member (EORTC – European Org for Research and Treatment of Cancer) – Cancer in the elderly; Member of National Academy of Medicine for medical oncology (AIOM);  Environmental Comm. Committee mmber appointed by the Minister of the Environment.

Prof Daniele Generali

MD

Former: Consultant Medical Oncologyst, Azienda Istituti Ospitalieri, Cremona and Prof of Medical Oncology, Trieste Univ; Former Prof of Molecular Oncology, Institute of Molecular Medicine, Oxford Univ. Member of the Board of European Commission for initiative on Breast Cancer; Director of the Unit of Molecular Therapy and Pharmacogenomics, Azienda Istituti Ospitalieri, Cremona; Clinical Director of the Italian Red Cross, Cremona Section; Scientific Director of the Association of Research in Oncology Onlus, Cremona.

I would just like to thank you all for your help, support and professionalism this year, I contacted you after my recurrence of breast cancer, everything was explained to me in detail and I decided to go ahead with the test, I am so glad I did, every one I dealt with was so kind and encouraging, I was very scared about the journey ahead of me. The promptness of all the team was amazing my biopsy was collected quickly and I was contacted by Sarah constantly with updates on what was happening. As soon as the tests were completed I was sent the report with a follow up telephone call from the Doctor who talked me through it, he said he would be available to answer any further questions.

I showed the report to my hospital. Doctors and they were impressed with the information gathered and I am on the drugs recommended in my report and I have been really well with no side effects. Thank you all again.

I would like to pass not only my, but my father’s, gran’s and entire family and friends appreciation to not only Oncologica® but to you directly. Sarah, you went above and beyond what was expected, you took a personal interest and gave huge support. Your tone was always polite and you helped to listen to myself during the emotional moments when speaking. The hope you as a person gave and the encouragement, helped when I had to mount the challenge on behalf of my mother and father. Myself and my father agreed before taking to Oncologica® that as long as we tried all avenues and did everything we could for my late mother, this would be the only way we could coped.

Without yourself and Oncologica® we would not have been able to achieve the goal. My late mother took hope, encouragement and huge amounts of mental positively from the work but more importantly the personal touch you gave. As a person your indirect support helped my late mother. A person who didn’t praise health professionals easily due to career in the NHS and private sector. She praised you from the information, hope and personal feel you gave. You helped to give her peace of mind and know all options were looked into. I can’t sum up our, my feelings as they hold you in the highest regard. Perhaps, to say you have our eternal gratitude summons it all.

I just wanted to get in touch to thank you and the whole team at Oncologica® for the reports you did for my Dad. Despite a very poor prognosis, following the advice in the Oncologica® reports he has been receiving an immunotherapy drug under Dr Fennelly in St Vincent’s Hospital, Dublin, since the early spring and is now in much better health. The latest scans show a significant reduction in the size of the main tumour and a stagnation in the growth of secondary tumours. He is no longer in significant pain and is able to enjoy day to day life again. Thank you all for your hard work, we really appreciate it.

After being diagnosed with stage 4 lung cancer my mothers only treatment option on the NHS was chemo therapy. The doctors gave her 6 months without treatment and only 9 with treatment but her quality of life would have been awful if undergoing chemo therapy.

After finding Oncologica® their help, advice and support have been second to none. Their ground breaking analysis and treatment options enabled my mother to undergo immunotherapy which has successfully reduced the size of her tumour and thankfully she is still with us over 2 years later. This would have not been possible without Oncologica®!

Without Oncologica® we do believe that my mother would no longer be with us but through them and their continued support she is still hear and enjoying her life with us and able to watch her grand children grow and play. We cannot thank Oncologica® enough for everything they have done and their continued support and cannot recommend them highly enough.” Many, many thanks from the whole family.

Karan Jensen was diagnosed in 2017, aged 48 with cervical cancer. Karan ordered the Oncofocus® Test to identify additional treatment options and shares her story here in the following Q&A.

How did your diagnosis come about?

I had been having regular smear tests, but then one came back with irregular cells and the doctor asked to see me in 6 months time. We were moving, so I delayed going back, but when I did get to the doctors, they ended up doing a biopsy. Within 2 weeks I was diagnosed with Stage 2B cervical cancer with lymph node involvement.

What happened after you were diagnosed?

Treatment was started to cure my cancer. I had four cycles of chemotherapy plus 32 sessions of radiotherapy.

Did this treatment work?

Unfortunately, the tumour did not change with this type of chemotherapy, so I then started on alternative therapies.

Did the second round of treatment work?

I was meant to have six sessions of this chemotherapy, but after three, I had a scan and found out that the tumour had grown. I was told that there was no point continuing treatment as my cancer was incurable, and to go home and get things in order.

Did you experience any side effects of chemotherapy?

During chemotherapy, I was hospitalised four times with infections and neutropenic sepsis. The chemotherapy also caused swelling of my legs (lymphoedema), and my kidneys had been damaged so that I had to have a nephrostomy bag attached to collect urine.

How did you feel when they told you that you cancer was incurable?

I have an 11-year-old son, so I was not going to give up and did some research online on the best treatments for my cancer.

What did you find searching online?

I found out about the Oncofocus®® cancer test by Oncologica® on their website and got in touch.

Was it easy getting the Oncofocus® test done?

It cost £2000 but it was an easy decision to make. I just had to fill in a few forms and Oncologica® did all the work to get the biopsy from my hospital.

What were the results of the Oncofocus® test?

The test quickly came back that my tumour was exceptionally high in a protein called PD-L1, so it would respond really well to immunotherapy, which works by boosting a person’s immune system to help it recognise and fight cancer cells.

What happened when you knew the results of the test?

The treatment that the test recommended was not available on the NHS so my oncologist contacted Christie Hospital in Manchester, which was part of the PROCLAIM-CX-072 clinical trial that is investigating an experimental drug that targets PD-L1.
I was very sick at this stage, and the doctors were not sure that I would be well enough to get into the trial. As my levels of PD-L1 were so high, however, they thought they had to give me the opportunity.

Was this new treatment successful?

I was meant to have four sessions of CX-072 plus ipilumumab every 3 weeks, plus CX-072 maintenance therapy for a year. Although the treatment was not as bad as chemotherapy and I did not lose any hair, it still made me feel very poorly. After the third session, I developed a bad reaction and the level of some of my white blood cells that fight infection, neutrophils, plummeted and could not be restored to normal. It was therefore too risky to continue the treatment.
The good news was that a scan in March this year showed that the new therapy had reduced the tumour by 50%.

Are you still receiving treatment?

Even though the treatment has stopped, my immune system has taken over and is fighting the tumour. I am scanned every 2 months, and every time my tumour reduces by a further 0.5% to 1%. Last week I had another scan, and it had reduced by 3% and I feel better today than I have over the past 3 years.

What are your thoughts on the Oncofocus® test?

If I had had the test before receiving chemotherapy, this would have saved the NHS a load of money giving me a treatment that did not work and putting me through so much. I continue to need a nephrostomy bag due to the damage done by chemotherapy, which needs changing once a week and the tubes replaced in hospital every 3 months.

What is happening now?

We are now at the ‘watch and wait’ stage. However, as I have had such a good response to the immunotherapy and feel so much better, I can have more treatment if needed in the future. The swelling in my leg has gone down and I can now wear my shoes and move around normally again. I was so sick that I did not think that I would see last Christmas. Now I will get to experience Christmas again this year.

Prof Giovanni Palazzoni

MD

Former Manager of the Centre for antiblastic drug (UFA) preparation, he has delivered ECM courses for nursing staff involved in antiblastic drugs, provided expertise on linear accelerators use and fissile material implants, he has managed a chemotherapy day hospital, Cobalt therapy plant and chemotherapy, biohazard drugs and vaccines which can potentially be fatal. He has managed partially inactivated pathogens, oncological radiotherapy, manipulated antineoplastic agents, run clinical physics lab simulations and managed the digital image processing for therapeutic planning at the Columbus Integrated Complex Gemelli and University Polyclinic Foundation.  He was also an editor of the bestselling book "Seno Buono Seno Cattivo" ie Good Breasts-Bad Breasts in art, illness, and reconstructive surgery.

I was diagnosed with terminal bowel cancer in March 2018. I started radiotherapy, which worked well. The tumour then started to cause a build up of fluid in my abdomen, which chemotherapy helped to reduce. However, when the first line chemotherapy stopped working after 5 months and then the second line chemotherapy failed to work at all, the fluid returned and I had two stays in hospital to help drain it.

Having exhausted standard therapy and become bedbound, I found out about the Oncofocus® Test from an online search. The overall process from submitting the form to Test results was easy and rapid. The company called to talk me through the process and to explain the results of the Test, and also took care of the logistics of collecting the sample from the hospital. It turned out that I have a rare cancer mutation and was lucky to have had a response at all to the initial chemotherapy.

I had a remarkably effective and rapid response to the drugs that the Test recommended for my cancer mutation. After just 2 weeks of treatment, my abdomen returned to normal size. After 4 weeks of treatment, I was swimming, walking and fully enjoying all that life has to offer again. I am truly grateful for the significant improvement in quality of life I experienced, especially as I had no side effects from the new drugs. The extra months that this gave me meant that I had further quality time with my family and could prepare them better for life without me.

A father of two with terminal cancer has been given new hope after being offered a free pioneering test to help find alternative treatments.

Mick Weldon, 38, from Cambourne, has a rare form of stomach cancer which is resistant to conventional forms of treatment.

In April, the News reported on Mick’s efforts to crowdfund enough money to cover the cost of analysis of new treatments.

After reading his story, Cambridge-based research company Oncologica® approached Mick to offer a ground-breaking test for free.

Mick was first admitted to hospital in December 2015 with a suspected ruptured ulcer, only to be later diagnosed with a cancer that had spread to his abdomen, liver, and surrounding organs.

Doctors found that Mick had a rare subset of Stage 4 GIST stomach cancer called wild type SDH deficient, which is incurable, but could be held at bay by new drugs.

Normally costing around £1,500, Mick under went an Oncofocus® test, which has been developed to detect every mutation linked to every drug and applicable to all tumour types.

Oncologica® claim that the test can identify specific treatment options in 85 to 90 per cent of patients.

Mick’s results show that a certain protein, PDL-1, expressed by his tumours, was acting as a ‘cloaking agent’ and effectively hiding the tumour from his immune system.

He now hopes his crowdfunding efforts will help to finance three cycles of anti-PDL-1 drugs.

“I’ve gone from having no options to a lot of options,” he said. “I’m amazingly positive. I’ve gone from a place where I had no hope to where I have a viable option. We’re all really upbeat.”

Mick hopes new treatments will give him more time to spend with his wife Emma and daughters Charlie, 17, and Rebecca, 15.

He previously said: “No one prepares for their own death, no wife wants to stand by and watch her once proud strong husband slowly degrade, and I can’t even begin to imagine how hard it must be for two beautiful young ladies to watch the father they have looked up to for as long as they have known slowly slip away.”

If Mick is able to secure the funding for his three cycles of drugs he hopes the evidence gathered will benefit other cancer patients.

“The NHS needs evidence,” he said. “We have to prove these drugs are viable.”

“I’d like to be in a position to start up a database where people can find this information where people can look up their options.”

He also remains realistic about how any new drugs will help his condition, but very thankful to the support of Oncologica®.

“Even if this fails, at least something is being done and I’m not just waiting to die,” Mick said.

“[Oncologica®] are absolutely amazing people. It buoyed me up. Until that point I was coming to the end of conventional treatment.”

Dr Marco Loddo, co-founder and scientific director at Oncologica®, said: “We saw the article and learnt about Mick’s story and in particular that his tumour type was quite rare and found out that he had exhausted all treatment options on the NHS.

“We hoped that we might be able to help with our tests. We’re happy to help.”

Oncologica® is a precision oncology services laboratory and contract research organisation founded in 2014.

Its Oncofocus® test aims to help encourage a move away from toxic non-specific cancer treatments to the use of the new generation of biological anti-cancer agents called targeted therapies.

Targeted therapies specifically hit cancer cells and not the normal cells of the body. They are said to be more effective than chemotherapy because patients are spared severe toxic side effects such as hair loss, infections, anaemia, gut toxicity and fatigue.

Professor Gareth Williams, co-founder and medical director, said: “What we are doing is to optimise the treatment pathway to provide a roadmap and that can have huge benefits for patients. You can avoid all the toxicity issues.”

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