histocyte Based in the heart of Newcastle University campus, 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.
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 on all major platforms 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
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 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.