About - HistoCyte Laboratories: Developing Quality Controls

Products
- Dynamic Range Controls
  - HER2^DR
  - ER^DR
  - PR^DR
  - BREAST^DR
  - HPV/p16^DR
  - PD-L1^DR
  - ROS1^DR
  - ALK^DR
- Standard Controls
  - MMR
  - MLH1/PMS2
  - MSH2
  - MSH6
  - ALK-EML4
  - ROS1
  - ALK-NPM
  - ER, PGR, HER2
  - HPV/p16
  - NTRK
  - BRAF
- Antibodies
  - hTERT
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About Us

Company
Directors
Advisors

The Company

Based in Newcastle upon Tyne, HistoCyte Laboratories Ltd is certified to the EN ISO 13485:2016 standard. We have been able to work closely with academic scientists and pathologists in order to test our product range and engage with experts in the histopathology field. This, together with the relationships we have developed with other key opinion leaders and institutions, has allowed us to clearly identify the needs of scientists. As a result, we aim to deliver high quality, reproducible and cost-effective analyte control material for same-slide use in histopathology. Our current products include controls for PD-L1, Her2, ER, PR, EML4-ALK, ROS1, NPM-ALK, HPV and p16, with many more in development. The products are available in a range of formats to suit the individual workflow and requirements of each laboratory.

The Products

Each product is available as pre-cut slides or as full blocks of cell micro-arrays. They contain 2mm diameter cores that are between 3mm and 3.5mm in length. Appropriate cell lines are selected that deliver the required range of expression for any given biomarker. This can be as simple as a positive and negative to prove reagents have been applied to the slide correctly, or as complex as a full range of expression to demonstrate assay sensitivity. The cell lines are processed in-house using our proprietary methods that allows for the creation of a very high density cell block with cells that retain their morphology. Most importantly, the process is cost-effective so we are able to deliver the products to the customer at a fraction of the cost of conventional control material.

All of our products are validated with standardised assays where available and are assessed in field by a wide number of laboratories so you can trust that the results are consistently reproducible in your laboratory. To view a full list of our products, head over to the products page. Alternatively, if you wish to find out more about our product pipeline, then please contact us.

The Aim

It is recognised that the identification of suitable archive tissue for use as controls in slide based assays can be difficult due to heterogeneous expression of biomarkers, fixation artefacts, rarity of their expression, or just general lack of availability. Currently, some laboratories run single batch controls per staining run. However, most fully automated staining platforms treat each slide in an individual fashion and therefore the use of single slide controls is best practice as it reflects what has happened to each individual slide. The requirement for single slide controls compounds the issue of suitable control tissue availability.

The novel technology developed by HistoCyte Laboratories Ltd employs cell lines to avoid these issues and allows us to process the cell lines in to tissue-like controls. These controls also have the advantage of being manufactured to a reproducible standard and with inexhaustible supply. Our aim is to deliver this cost-effective control material to laboratories looking to improve confidence in their results and ultimately the service they offer. We will continue to expand our product range to include additional biomarkers, working closely with key opinion leaders in industry and academia to develop control material that is relevant and that provides confidence where it is most needed.

The History

The founders, Dr Ian Milton and Colin Tristram, share over 30 years of experience in the development of diagnostic products, including cell line controls for use in diagnostic assays. As a result, we understand the requirements of the market and are manufacturing products that we know can make a positive difference in laboratories across the world.

- Colin Tristram

Biography
Positions
Publications

Colin brings to HistoCyte Laboratories Ltd a wealth of commercial and clinical knowledge given his experience and connections within the IVD field from the last fifteen years. Colin studied Medical Microbiology at the University of Newcastle upon Tyne with a specific interest in immunology. He subsequently joined the expanding R&D hybridoma team at Novocastra Laboratories Ltd as a Research Associate helping to develop the range of monoclonal antibodies. As part of Colin’s MSc he studied Her2 in breast cancer and breast cancer cell lines looking at differences in expression of internal and external domains. As a consequence of this work he developed in-house procedures for the processing of formalin fixed paraffin embedded cell lines used as immunohistochemical controls. These were subsequently adopted by various laboratory External Quality Assurance Schemes, namely The UK National External Quality Assurance Scheme for Immunocytochemisty and In-situ hybridisation (UKNEQAS-ICC & ISH).

Following the acquisition of Novocastra Laboratories Ltd by Vision BioSystems Ltd, Colin joined the commercial team expanding the sales of monoclonal antibodies and the Bond automated IHC/ISH platform throughout the UK, Europe and USA. As a consequence Colin developed a wide network of pathologists and researchers in many of the top hospitals and institutes enabling him to develop a Key Opinion Leader program and company publication reAGENTS.

After the acquisition of Vision Biosystems Ltd by the Danaher corporation Colin created the Innovation department at the Newcastle Leica Biosystems facility. The department was responsible for the qualification of projects from a clinical and commercial perspective prior to any R&D work. Over this period there was the development of class I and class III devices and wider collaborations with academics, clinicians and other companies within the biotech industry. Colin was instrumental in developing an Ideation process that worked for an IVD development work stream within the Danaher Business Systems Accelerated Development Process (APD).

As well as being a member of the Pathology Society of Great Britain and Ireland, Colin has previously been an assessor for UKNEQAS. Additionally, since 2010 Colin has been a Consultant and Guest Lecturer for the University of Newcastle upon Tyne at the Graduate School, Faculty of Medicine.

• 2012 to date
Director, Bioconnexions Consulting Ltd.

• 2007-2012
Head of Innovation, Leica Microsystems (acquired Vision Biosystems), Newcastle.

• 2006-2007
Market Development Manager, Vision Biosystems, Newcastle.

• 2005-2006
Corporate Accounts Manager - Europe, Vision Biosystems, Newcastle.

• 2004-2005
Technical Specialist, Vision Biosystems (acquired Novocastra), Newcastle.

• 1999-2004
Research Associate, Novocastra Laboratories Ltd, Newcastle

• Chapter 6. Standard Reference Material: Cell Lines Development and Use of Reference Cell Lines as Standards for External Quality Assurance of HER2 IHC and ISH Testing. In Taylor C, Shi S (eds.) Jasani B, Reid V, Tristram C, Walker J, Scorer P, Morgan M, Bartlett J, Ibrahim M, Miller K Antigen Retrieval Immunohistochemistry Based Research and Diagnostics. 1st ed Hobeken, NJ: Wiley-Blackwell; 2010. p101-122.

• Phospho-STAT5 and phospho-Akt expression in chronic myeloproliferative neoplasms.
Grimwade LF, Happerfield L, Tristram C, McIntosh G, Rees M, Bench AJ, Boyd EM, Hall M, Quinn A, Piggott N, Scorer P, Scott MA, Erber WN. Br J Haematol. 2009 Nov;147(4):495-506.

• Experimental validation of peptide immunohistochemistry controls.
Bogen SA, Vani K, McGraw B, Federico V, Habib I, Zeheb R, Luther E, Tristram C, Sompuram SR. Appl Immunohistochem Mol Morphol. 2009 May;17(3):239-46.

• The mouse tumor cell lines EL4 and RMA display mosaic expression of NK-related and certain other surface molecules and appear to have a common origin.
Gays F, Unnikrishnan M, Shrestha S, Fraser KP, Brown AR, Tristram CM, Chrzanowska-Lightowlers ZM, Brooks CG. J Immunol. 2000 May 15;164(10):5094-102.

- Ian Milton

Biography
Positions
Publications

As Technical Director of HistoCyte Laboratories Ltd, Dr Milton provides a strong scientific background. Dr Milton gained his PhD at the University of Newcastle upon Tyne and began his career in the development of monoclonal antibodies in a University spin-out company called Novocastra Laboratories Ltd over 20 years ago. This was the origin of his experience in biotechnology research and development. Over this period Dr Milton became involved in both general management and R&D management. Specifically he has gained detailed experience in the implementation and management of control systems for the design and manufacture of in vitro diagnostic products.

Dr Milton has extensive experience in guiding fast growing organizations through post-acquisition cultural change and the transition from private to public ownership. In 2002, Novocastra was acquired by an Australian company, Vision BioSystems Ltd. This resulted in considerable change and growth for the Novocastra facility now called Vision BioSystems Newcastle Ltd. Subsequently in 2007 Vision BioSystems Ltd was acquired by the Danaher Corporation and incorporated into Leica Microsystems to create the Biosystems Division Leica Biosystems Newcastle Ltd.

Each acquisition was with a back drop of great regulatory change in the EU, USA and China. This provided Dr Milton with experience in the implementation of changes required to transform the company to comply with ISO design and manufacturing standards and conformity to FDA and SFDA standards and subsequent release of IVD labeled products.

• 2011 to date
Director, Bioconnexions Consulting Ltd.

• 2011
Chief Scientific Officer, Leica Biosystems Newcastle Ltd.

• 2008
Managing Director, Leica Biosystems Newcastle Ltd.

• 2003
Research and Operations Director, Vision Biosystems Newcastle Ltd.

• 2001
Research Director, Novocastra Laboratories Ltd.

• 1994
Research and Development Manager, Novocastra Laboratories Ltd.

• A monoclonal antibody for detection of folylpolyglutamate synthetase in paraffin embedded tissues.
Quinn AE, Pinkney M, Piggott NH, Calvert H, Milton ID, Lunec J. Hybridoma (Larchmt). 2009 Dec;28(6):415-21. doi: 10.1089/hyb.2009.0040.

• A novel monoclonal antibody for detection of folate receptor alpha in paraffin-embedded tissues.
Smith AE, Pinkney M, Piggott NH, Calvert H, Milton ID, Lunec J. Hybridoma (Larchmt). 2007 Oct;26(5):281-8.

• Wild-type estrogen receptor beta expression in normal and neoplastic paraffin-embedded tissues.
Rees ML, Marshall I, McIntosh GG, Gray J, Mitchell K, Pinkney M, Piggott NH, Horne CH, Milton ID. Hybrid Hybridomics. 2004 Feb;23(1):11-8.

• NCL-CD10-270: a new monoclonal antibody recognizing CD10 in paraffin-embedded tissue.
McIntosh GG, Lodge AJ, Watson P, Hall AG, Wood K, Anderson JJ, Angus B, Horne CH, Milton ID. Am J Pathol. 1999 Jan;154(1):77-82.

• The expression of the glial glutamate transporter protein EAAT2 in motor neuron disease: an immunohistochemical study.
Fray AE, Ince PG, Banner SJ, Milton ID, Usher PA, Cookson MR, Shaw PJ. Eur J Neurosci. 1998 Aug;10(8):2481-9.

• Expression of the glial glutamate transporter EAAT2 in the human CNS: an immunohistochemical study.
Milton ID, Banner SJ, Ince PG, Piggott NH, Fray AE, Thatcher N, Horne CH, Shaw PJ. Brain Res Mol Brain Res. 1997 Dec 1;52(1):17-31.

• New monoclonal antibodies to oestrogen and progesterone receptors effective for paraffin section immunohistochemistry.
Bevitt DJ, Milton ID, Piggot N, Henry L, Carter MJ, Toms GL, Lennard TW, Westley B, Angus B, Horne CH. J Pathol. 1997 Oct;183(2):228-32.

• Production and characterization of a new monoclonal antibody effective in recognizing the CD3 T-cell associated antigen in formalin-fixed embedded tissue.
Steward M, Bishop R, Piggott NH, Milton ID, Angus B, Horne CH. Histopathology. 1997 Jan;30(1):16-22.

• Feline calicivirus strain differentiation using monoclonal antibody analysis in an enzyme-linked immuno-flow-assay.
McArdle F, Dawson S, Carter MJ, Milton ID, Turner PC, Meanger J, Bennett M, Gaskell RM. Vet Microbiol. 1996 Aug;51(3-4):197-206.

• Prokaryotic expression and analysis of the antibody response to a Newcastle isolate of the core gene of hepatitis C.
Milton ID, Watson JP, Guo K, Carter MJ, Bassendine MF, Toms GL. J Med Virol. 1995 Mar;45(3):253-8.

• A gene probe to detect feline calicivirus from tissue samples.
Meanger J, Dawson S, Milton ID, Carter MJ, Gaskell RM, Turner PC. Biochem Soc Trans. 1993 Nov;21(4):465S.

• An inexpensive and simple method for DNA purifications on silica particles.
Carter MJ, Milton ID. Nucleic Acids Res. 1993 Feb 25;21(4):1044.

• Scheme of RNA transcription in calicivirus-infected cells.
Meanger J, Carter MJ, Milton ID, Bennett M, Gaskell RM, Turner PC. Biochem Soc Trans. 1993 Feb;21(1):67S.

• Cloning and sequencing of a plasmid-mediated erythromycin resistance determinant from Staphylococcus xylosus.
Milton ID, Hewitt CL, Harwood CR. FEMS Microbiol Lett. 1992 Oct 1;76(1-2):141-7.

• The complete nucleotide sequence of a feline calicivirus.
Carter MJ, Milton ID, Meanger J, Bennett M, Gaskell RM, Turner PC. Virology. 1992 Sep;190(1):443-8.

• Location of monoclonal antibody binding sites in the capsid protein of feline calicivirus.
Milton ID, Turner J, Teelan A, Gaskell R, Turner PC, Carter MJ. J Gen Virol. 1992 Sep;73 (Pt 9):2435-9.

• Genomic 3' terminal sequence comparison of three isolates of rabbit haemorrhagic disease virus.
Milton ID, Vlasak R, Nowotny N, Rodak L, Carter MJ. FEMS Microbiol Lett. 1992 May 15;72(1):37-42.

• Identification and sequence determination of the capsid protein gene of feline calicivirus.
Carter MJ, Milton ID, Turner PC, Meanger J, Bennett M, Gaskell RM. Arch Virol. 1992;122(3-4):223-35.

Alan Colman

MA PhD

Dr. Alan Colman born in Manchester, UK, received a BA (1971), MA (1975) and PhD (1975) from Oxford University. He is currently a Visiting Scholar at the Harvard University Department of Stem Cell and Regenerative Biology. From 2007 to 2013 he served as the Executive Director of the A*STAR Singapore Stem Cell Consortium (SSCC). Concurrently, Dr. Colman was Professor of Regenerative Medicine at King’s College, London, UK, from 2008 to 2009. Prior to joining the SSCC, Dr. Colman was Chief Scientific Officer and then CEO for the Singaporean human embryonic stem cell company, ES Cell International, from 2002 to 2007. He was the research director of the company PPL Therapeutics in Edinburgh, UK, from the late 1980s until 2002, where he was responsible for leading PPL’s research program strategy. This company attracted considerable media attention because of its collaboration with the Roslin Institute that led to the world’s first sheep cloned from an adult cell, Dolly, in 1996.

Between 1974 and 1992 Dr. Colman enjoyed a successful university career in the Universities of Oxford, Warwick, Birmingham (where he was Professor of Biochemistry) and London (as mentioned above). He now lives in S.W France where, in addition to his professional commitments at Harvard and Genea Biocells, he is advisor to HistoCyte Laboratories Ltd. With his extensive cell biology knowledge and experience he is helping in their approach to applying the right cells to the various pathologies.

Andy Hanby

BM PhD FRCPath

Currently a Professor of breast pathology and consultant histopathologist at Leeds University, Professor Hanby originally studied medicine at Southampton University and subsequently trained in London. He balances a considerable clinical work load with his academic and teaching commitments and his other tasks include management of parts of the molecular pathology service and the interpretation of molecular pathology tests; mostly HER2 FISH, but also some of the GI assays such as Whipples and K-Ras mutation analysis.

As part of Professor Hanby’s clinical commitment he directs the regional HER2 service originally providing tests for Leeds and the wider Yorkshire region. Initially providing a fluorescent in situ hybridization (FISH) service his service now provides dual-color dual-hapten brightfield in situ hybridization (DDISH) assay. The quality of the service is considered by the United Kingdom-National External Quality Assurance Scheme (UKNEQAS) to be of high quality and is a reference centre for HER2 in-situ hybridisation.

Professor Hanby is an assesor for UKNEQAS for the Her2 module as well as other markers. As a member of the National Health Service Breast Screening Programme (NHSBSP) Pathology BIG 18 Professor Hanby is helping to influence the standards and quality of breast pathology practice with benefits locally and nationally. With regard to Professor Hanby’s academic commitment, he is Deputy Head of Section of Pathology and Tumour Biology, Yorkshire Cancer Research and Liz Dawn Pathology and Translational Professor Hanby is an invited author for the World Health Organisation: classification of Tumours of the breast.

Glenn McCluggage

MB BCh BAO FRCPath

Professor Glenn McCluggage is a consultant Histopathologist in Royal Group of Hospitals Trust, Belfast and an Honorary Professor in Gynaecological Pathology of Queen’s University of Belfast. Glenn has published over 400 papers in peer reviewed journals, including original publications and many invited editorials and reviews, and is on the Editorial Board of four major pathology journals and associate editor of Histopathology. Currently President of International Society of Gynecological Pathologists and previous secretary of this society. Previously, he was President of the British Association of Gynaecological Pathologists.

Professor McCluggage has an extremely busy referral practice and has been invited to lecture at numerous national and international meetings. Having authored or co-authored the various Royal College of Pathologists datasets in United Kingdom on reporting of gynaecological malignancies and having chaired the ICCR (International Collaboration in Cancer Reporting) panels developing international guidelines for reporting endometrial and ovarian carcinomas, he is currently chairing the ICCR panel developing the cervical cancer dataset. Glenn has been part of the last 2 WHO groups formulating the classification of Tumours of the Female Genital Tract and his main diagnostic interests are gynaecological malignancies and the uses of immunohistochemistry in gynaecological pathology.

Marco Novelli

MB ChB MSc PhD FRCPath

Marco is a consultant histopathologist at University College London hospital (UCLH) and Professor of gastrointestinal pathology at University College London (UCL). Recognised nationally as an expert in his field Marco receives referral cases from within the London network and across the UK. Marco is also a member of the National Bowel Screening Programme expert histopathology panel. He also represents the Royal College of Pathologists on gastrointestinal pathology matters at the National Institute of Clinical Excellence (NICE) and National Cancer Intelligence Network.

Extensively published in his field Marco’s current areas of research include ploidy analysis in Barrett’s oesophagus, intra-abdominal stromal tumours and colorectal cancer. Frequently invited to speak at national and international meetings Marco also contributes to various books and is on the editorial board of a number of international journals.

Manuel Salto

MD-LMS FRCPath FRCPI

Professor Manuel Salto-Tellez is the Chair of Molecular Pathology at Queen’s University Belfast, Clinical Consultant Pathologist at the Belfast Health and Social Care Trust and Deputy Director of the Centre for Cancer Research and Cell Biology.

By May 2016, Prof Salto-Tellez was author or co-author of more than 220 internationally peer-reviewed articles in translational science, molecular pathology and diagnostics, including work published in NEJM, Nature Medicine, Gastroenterology, FASEB, EMBO, Cancer Research and Clinical Cancer Research, among others. He has published a similar number of abstracts in international conferences, and is editor or contributor to some of the key textbooks of pathology and oncology. Professor Salto-Tellez studied Medicine in Spain (Oviedo), Germany (Aachen) and The Netherlands (Leiden). He specialized in Histopathology in the UK (Edinburgh and London) and in Molecular Pathology in USA (Philadelphia). For more than 10 years he worked at the National University of Singapore and its National University Hospital, where he was associate professor, senior consultant, director of the Diagnostic Molecular Oncology Centre, Vice-dean for Research and senior scientist at the Cancer Research Institute.

Prof Salto-Tellez serves on a number of committees nationally and internationally. His academic work has been recognised on numerous occasions and is reflected by his membership to the editorial boards of several journals. At present he holds more than £4.9M in active and competitive grant funding and currently leads the Northern Ireland – Molecular Pathology Laboratory (NI-MPL). The CPA accredited MPL is responsible for the molecular diagnostics of the whole of Northern Ireland.