logo
 Quality in Control
LinkedIn
Home / Bioconnexions / Contact / Terms of Use /
Latest Information from HistoCyte Labs

Click to show/hide details.

May 2018 > ER Launch: Estrogen Receptor Analyte ControlDR
Continuing our expansion of breast biomarkers, we have released a new Estrogen Receptor Dynamic Range Analyte Control with improved sensitivity. Containing four cores including low and mid expressing cell lines rather than just negative and high, this new ER control is ideal for those wanting increased sensitivity. This cost-effective control is supplied in blocks and slides and is perfect for same-slide use so that increased confidence in results can be achieved by all laboratories.

For more information, please contact info@histocyte.

Feb 2018 > HER2 Launch: HER2 Analyte ControlDR
As we look to strengthen our product range for quality control in breast cancer testing, we are pleased to announce the launch of a specific HER2 Dynamic Range Analyte Control. In addition to negative, 1+ and 3+ expressing cell lines, this new product includes a 2+ cell line that is equivocal by FISH. By providing this cost-effective material with improved sensitivity it will confer greater confidence in HER2 IHC and ISH assays when used on the same slide.

For any enquiries, please contact info@histocyte.

Oct 2017 > Focus on HPV
HPV Presentation
This month we turn our attention to our HPV/p16 products and we have adapted a presentation from earlier in the year that provides an analysis of the current situation. These products were born from a collaboration with Dr Max Robinson, a Senior lecturer in Oral Pathology at Newcastle University and Keith Miller from UKNEQAS-ICC & ISH.

In clinical trials the volume of control material for same slide use is excessive and therefore not consistent across all the tests considering the number of samples assessed. An inexhaustible supply of standardised material was extremely beneficial in this case. For external quality assurance assessments, while interpretation on tissue is important, standardised material to determine the technical aspects is vital. Of course the material lends itself to routine use being a cost-effective control for same slide use as previously described.

In this summary we provide some background to the product, the diseases and how the use of our control material can improve confidence in HPV in situ hybridisation and p16 immunohistochemistry results. It also details the results and findings of a ring study where we demonstrate the effectiveness across a number of sites. If you would like more information, please contact info@histocyte.

Sep 2017 > Recognition for HistoCyte
PDL1 Staining
It is great to have our products for PD-L1 recognised by Members of the Pulmonary Pathology Society in their recent publication: Archives of Pathology & Laboratory Medicine Journal (Thunnissen et al.). This comes on the back of being mentioned in the International Association for the Study of Lung Cancer publication: IASLC Atlas of PD-L1 Immunohistochemistry Testing in Lung Cancer. As we have an extended range of control material for lung including ALK and ROS1, we hope to see more publications over the next 12 months. We are looking to launch Dynamic Ranges for both ALK and ROS1 over the next year too.

Sales: sales@histocyte.com
Enquiries: info@histocyte

Aug 2017 > PD-L1 Collaboration
PDL1 Poster
As interest in our PD-L1 Analyte ControlDR product has increased since its launch, HistoCyte Laboratories Ltd has embarked on a number of collaborations. We recently concluded a study between ourselves and image analysis experts Visiopharm. This was conducted by a medical student seconded to our laboratories.

Arunn Sri Ravichelvan looked at what “failed” immunohistochemistry (IHC) tests with the cells looked like by image analysis. He did this by creating a baseline reading from standard IHC runs. He was then able to compare the following to this baseline: section thickness, inappropriate epitope retrieval, incubation times and antibody concentration. A pdf of the poster can be found here.

With additional data from other groups we will look to include this data in a future publication. This current data demonstrated how stable the product is across three independent batches of product. In addition to being a good quality control tool it could potentially help in troubleshooting a failed test.

We wish Arunn all the best for his future studies.

Jul 2017 > HistoCyte at NordiQC
At the NordiQC meeting in Aalborg, HistoCyte laboratories Ltd were invited to present as one of the sponsoring companies. Dr Ian Milton talked about one of our leading works in R&D: ALK Analyte ControlDR. While HistoCyte Laboratories currently have two products for ALK in Lung and Lymphoma, we know from experiences with our customers and from working closely with various external quality assurance (EQA) schemes that some still struggle with their assay optimisation and appropriate sensitivity for the specific ALK translocation, or more specifically the resulting fusion protein. In this presentation, Dr Milton discussed the combination of cells containing EML4-ALK (associated with non-small cell lung carcinoma), NPM-ALK (associated with anaplastic large cell lymphoma), Wt ALK and a negative control. This combination clearly demonstrates the appropriate sensitivity of the ALK assays.

This product is expected to be launched in early 2018. For any enquiries, please contact info@histocyte.

Jun 2017 > New ROS1 Control Material Released
Further expanding our lung panel, the new ROS1 Analyte Control is now available from HistoCyte Laboratories. Visit the ROS1 product page for more information.
May 2017 > HistoCyte Laboratories Receives EN ISO 13485:2016 Accreditation
We are delighted that our commitment to working to the highest standard has been recognised with our certification for EN ISO 13485:2016. Our Quality Management System allows us to provide high quality solutions to pharma and biotech and we also have the capacity to develop our own products with IVD status as required.

A copy of our certificate can be found here.

ISO 13485:2016 Logo

Dec 2016 > HistoCyte Laboratories HPV/p16 Analyte ControlDR recognised in recent publication regarding the use same slide controls in HPV and p16 assays.
HistoCyte Laboratories Ltd's first product came through a collaboration with the Dr Max Robinson at the Royal Victoria Infirmary, Newcastle upon Tyne. A Senior Lecturer in Oral Pathology at Newcastle University, Dr Robinson required reliable control material for his work, in particular his clinical trials. This collaboration gave rise to the HPV Analyte ControlDR which with Dr Robinson’s help was extensively tested by IHC for p16 and ISH for E6/E7 mRNA and HPV DNA.

Dr Robinson has written a chapter in HPV Infection in Head and Neck Cancer, Recent Results in Cancer Research, Volume 206, Springer 2106, pages 101 to 111, in which he provides a review of current testing of HPV in head and neck cancer in clinical practice. As part of his review he discusses the need for standardised controls and refers to the HistoCyte Laboratories Ltd products as one means to meet these requirements.

It has been a pleasure working with Dr Robinson on this project and we look forward to future projects.

Jul 2016 > HistoCyte and Vitro Molecular Press Release
HistoCyte Laboratories Ltd partner with Vitro Molecular LLC to provide their quality control cell lines for immunohistochemistry and in situ hybridisation to the US.

• HistoCyte Laboratories Ltd will sell their products through Vitro Molecular Laboratories affiliate, Ancillary Pathways LLC.

• Vitro Molecular LLC are able to further Ancillary Pathways mission to enhance laboratories capabilities.

MIAMI, FL--(BUSINESS WIRE)--HistoCyte Laboratories Ltd (Newcastle upon Tyne, UK) and Vitro Molecular Laboratories LLC (Miami, FL) have signed a distribution agreement for the promotion of HistoCyte Laboratories Products in the USA. Through Vitro Molecular Laboratories affiliate, Ancillary Pathways LLC, HistoCyte Laboratories Ltd will have immediate access to their network of laboratory contacts. This will advance HistoCyte Laboratories commercial expansion and dissemination of their cell line based control material for use in immunohistochemistry (IHC) and in situ hybridisation (ISH). These products are unique as they closely resemble tissue morphology, producing immediately recognisable quality at an affordable price.

Colin Tristram, co-founder with Dr Ian Milton, expressed the HistoCyte team’s excitement directly supplying one of the world’s largest and innovative life science and biomedical markets. “For a company with a novel product, success depends upon the right partnerships. In partnering with Dr Yaziji through Vitro and Ancillary Pathways, we marry his team’s expertise with their network in the US market”. Dr Hadi Yaziji shares his team’s excitement, “We are equally thrilled to be able to rely upon the superb quality of cell lines by partnering with HistoCyte Laboratories Ltd and its experts”.

About HistoCyte Laboratories Ltd
HistoCyte Laboratories mission is to provide standardised control material for IHC and ISH. Traditionally tissues are used but these are not standardised across laboratories and can be of limited availability. HistoCyte Laboratories also provide contract development and manufacturing services to the biotech field. HistoCyte Laboratories have already established a distributor network across Europe and sell directly into the UK and Ireland.
About Ancillary Pathways LLC
Ancillary Pathways provide services to address the diverse needs of pathology laboratories of all sizes and in all settings. Their experts work collaboratively with laboratories to provide the specific training and logistical support needed for enhancing IHC and FISH testing capabilities. Ancillary Pathways is supported by an extensive network of experienced pathologists and scientists with many decades of practical experience in profitable laboratories. Internationally recognized physicians, scientists and technologists make up Ancillary Pathways’ growing Advisory Board.

May 2016 > New PD-L1 Control Material Released
HistoCyte is pleased to announce the release of our PD-L1 control material. Offering a dynamic range of expression for PD-L1 and multiple formats to suit your workflow, contact sales@histocyte for purchase enquiries.
Apr 2016 > HistoCyte Products Available in Canada
Inter Medico are now distributing HistoCyte products in Canada. We are delighted to be working with a company that prides itself on service and support excellence through their sales representatives, technical specialists, field service engineers and a customer technical response center that operates 24 hours a day, seven days a week.
Mar 2016 > Distribution in Germany
HistoCyte Laboratories is delighted to report that our entire product range is now available in Germany through Medac. Medac has a wide reach throughout Germany, supplying products to private practice, hospital laboratories, pharmaceutical and biotech companies, and research institutes.
Jan 2016 > Now Offering Contract Services
With our wealth of experience in the design and development of antibodies, probes and assays for IVD tissue-based diagnostics, we can now offer clients a range of contract services to assist in the development and commercialisation of their products. See the services section for examples of how we could help.
Dec 2015 > HistoCyte Receives ISO9001 Certification
The efficient processes we apply in manufacturing and our commitment to ensure our customers receive the highest quality product have been recognised in the form of ISO9001 accreditation from BSI.
Nov 2015 > Analyte Control for NPM-ALK Released
The NPM-ALK control contains 2 cores that offer positive and negative expression for the biomarker, available as slides or blocks. View our products page for more information.
Sep 2015 > Breast (Her-2, ER, PR) Analyte Controls Released
We have released a multi-purpose block for use with Her-2, ER and PR. The product is available in a 5-core format that offers a full dynamic range of expression for the 3 biomarkers, or a 2-core format that offers positive and negative control. As with all of our analyte controls, these can be purchased as pre-cut slides or as blocks to suit your workflow. View our products page for more information.
Aug 2015 > HistoCyte Receive SMART Award Funding
We have received SMART Award funding for a Proof of Market study to carry out market analysis as we look to expand our product range.
Jul 2015 > EML4-ALK Analyte Controls Released
Our ALK control contains two cell lines that demonstrate positive and negative expression of EML4-ALK. There are two formats available: control slides [HCL007](x2)[HCL008](x5) and control blocks [HCL009]. Each have their merit depending on the needs of the laboratory. The slides offer ease of use and save time in preparation. However, in high volume centers the blocks provide approximately 300 sections to offer a more cost effective solution and fit into the workflow of the laboratory easily.

In either case the analyte controls demonstrate that the reagents employed to perform the assay have worked effectively in combination with the staining protocol. Please visit our products page for more information.

May 2015 > HistoCyte Laboratories is Expanding!
After the release of our first product and the positive reception it has received, we turned our attention toward developing analyte controls for assays that we have identified a clinical need for. With two more product lines approaching commercialization and the uptake we are seeing with our HPV analyte controls around the world, we decided it was necessary to expand. As a result of this we have moved to a larger laboratory that offers a superior workflow and more efficient processing. Combined with the addition of some new equipment that allows us to bring more processes in-house, we believe we have the necessary means to meet the type of demand we expect when our next products come to market. If you have an unmet need in your laboratory or require a contract service please feel free to contact us.
Apr 2015 > Distribution in Europe
Our list of distributors throughout Europe is expanding. HistoCyte products are now available to purchase from Immuno Diagnostic Oy in Finland and Biosystems Switzerland AG. If you are interested in distributing our products then please contact us at info@histocyte.com.
Feb 2015 > Quality and Confidence in Tissue Diagnostics by Keith Miller of UKNEQAS
The Current Situation
In today’s cellular pathology service laboratories there is an ever increasing pressure to obtain more information from biopsies and the smaller resection samples generally provided for tissue diagnostics. This, combined with the ongoing demand for improving the quality of service, means that a suitable, high quality control material is imperative to a timely and correct diagnosis. The cost of finding this material from tissue banks and archives is often not fully appreciated. Moreover, for rare biomarkers or semi-quantitative assays, the demand for tissues with appropriate expression levels often exceeds the supply.

UKNEQAS (the United Kingdom National External Quality Assurance Scheme for ICC and ISH) assessments have often noted that internal control tissue being used routinely in subscribing laboratories is inappropriate or incomplete. The lack of availability of suitable control tissue means a laboratory may only have some of the tissue required to demonstrate the necessary expression levels of a given biomarker optimally. This finding highlights an increasing need for standardised control material for IHC and ISH testing, which in turn introduces the challenge of providing a cost effective solution that can be applied to every case tested.

Use of Cell Lines as Control Material - A Potential Solution
This requirement for standardised, reproducible control material of suitable protein expression was the reason that UKNEQAS originally investigated the use of cell lines for their Her2 assessment modules.1 This work was further developed in Newcastle upon Tyne and made robust on an industrial scale at Leica Biosystems Ltd. These cell lines were validated in a number of ways and jointly described in further work.2 Since then UKNEQAS has investigated a number of other areas where cell lines can be used as high quality control material, such as estrogen and progesterone receptor (ER and PR) assessment and, more recently, with ALK.

HistoCyte Laboratories Ltd
HistoCyte Laboratories Ltd builds on a track record in the IHC and ISH field. They are developing high quality analyte controls aimed at some of the more demanding assays that laboratories perform on a daily basis. These cell line control products remove the burden of locating, characterising and managing banks of precious control material and also avoid any ethical issues surrounding the use of patient material as controls. The adoption of well characterised, inexhaustible control material also means the introduction to the market of a universally accepted standard. This will bring about an increase in the quality of laboratory practice generally, which can only be a good thing.

I am very excited by what HistoCyte Laboratories Ltd will bring to this field and look forward to collaborating with Ian Milton and Colin Tristram as I have done in their previous enterprises. UKNEQAS works closely with industry partners in order to deliver high quality solutions to our colleagues in laboratories throughout the UK and beyond. Only through collaborating with the industry can we ensure that our needs are met and ultimately make sure quality services are delivered to the patient.

Keith Miller, FIBMS
Keith Miller has worked in the field of immunohistochemistry for over 30 years. He was previously the Technical Head of UCL-Advanced Diagnostics (formerly known as the UCL Immunocytochemistry Unit) since 1982. As Director of the UKNEQAS-ICC&ISH since 1992, Keith has recently helped establish an independent “not for profit” laboratory service Cancer Diagnostic Quality Assurance Services, Community Interest Company (CADQAS CIC) for UKNEQAS in order to support both the scheme and the tissue diagnostics community, including those in the commercial sector such as HistoCyte Laboratories Ltd.

1Rhodes, A., Jasani, B., Couturier, J., McKinley, M. J., Morgan, J. M., Dodson, A. R., Navabi, H., Miller, K. D. and Balaton, A. J. A formalin fixed, paraffin processed cell line standard for quality control of immunohistochemical assay of HER-2/neu expression in breast cancer. American Journal of Clinical Pathology, 2002. 117. pp. 81-89.

2Bogen SA, Vani K, McGraw B, Federico V, Habib I, Zeheb R, Luther E, Tristram C, Sompuram SR. Experimental validation of peptide immunohistochemistry controls. Appl Immunohistochem Mol Morphol. 2009 May;17(3):239-46.

Nov 2014 > RNAscope on Our HPV Control Slides
Results of the RNAscope
RNAscope is an RNA in situ hybridization (ISH) method that enables routine detection of genes in formalin-fixed paraffin-embedded (FFPE) tissue. It enables as much as 400-fold enhancement in signal-to-noise ratio, making it one of the most sensitive RNA ISH methods available. Advanced Cell Diagnostics Inc. have developed a HPV assay to the high risk types. The results here confirm HistoCyte’s HPV-CMA utility in IHC, DNA ISH and now RNA ISH.

Cell Line 1

High HPV

Cell Line 2

Med HPV

Cell Line 3

Low HPV

Cell Line 4

Neg HPV p16