cancer gene analysis

Medicines and Healthcare Products Regulatory AgencycontractContracts FinderRef cancer gene analysis - UKSCBSME suitableclosed
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Estimated value

Awarded value

Suppliers

0

Lots

1

0 awarded

Published

04 May 2018

Deadline 24 May 2018

Description

The UKSCB requires an external contractor (third party) to perform cancer gene analysis on UKSCB derived EU Tissue and Cellular Directive (EUTCD) compliant human embryonic stem cell (hESC) lines. UKSCB is licenced under the HTA Human Tissue (Quality and Safety for Human Application) Regulations 2018 for the production of starting materials for clinical application. According to HTA regulations any testing activities that are subcontracted to external contractors must be appropriately validated to demonstrate that the testing method is fit for purpose. In addition, the contract testing laboratory has to be accredited by the regulatory body for the licensable activities. It is estimated that the contact will run for at least of three years and will cover testing of approximately 38 hESC lines. The contact should be priced based on the number of cancer genes in the panel and DNA isolation from cell lines. Further communications or meetings can be arranged for additional details on the testing or validation. As part of ongoing UKSCB service provider qualification program the third party might require to fill UKSCB Quality Questionnaire or accommodate on-site audit by UKSCB. For further information and if you believe, you have the capability to do this work, please feel free to contact via email (Nawaz.habib@nibsc.org) before close of play 25 May 2018.

Scope

Reference
cancer gene analysis - UKSCB
Commercial tool
Standalone contract
CPV classifications
33159000 73110000
Particular suitability
Small and medium-sized enterprises (SME)

Submission & procedure

Submission deadline
24 May 2018, 11:00 pm