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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.
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.
This product is expected to be launched in early 2018. For any enquiries, please contact info@histocyte.
A copy of our certificate can be found here.
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.
• 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”.
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.
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.
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.
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.