1.1 Buyer
Official name
:
Universiteit Leiden
High throughput transcriptomics for the EFSA TXG-MAP project
In the context of the project Translational quantitative Toxicogenomics mechanism-based AOP mapping for human NAM-based risk assessment (TXG-MAP) project funded by the European Food Safety Agency (EFSA) we require fast and affordable high throughput transcriptomics analysis. In the context of the project Translational quantitative Toxicogenomics mechanism-based AOP mapping for human …
CPV: 73111000 Forschungslabordienste
1. Buyer
2. Procedure
2.1 Procedure
Title
:
High throughput transcriptomics for the EFSA TXG-MAP project
Description
:
In the context of the project Translational quantitative Toxicogenomics mechanism-based AOP mapping for human NAM-based risk assessment (TXG-MAP) project funded by the European Food Safety Agency (EFSA) we require fast and affordable high throughput transcriptomics analysis.
Procedure identifier
:
ae8e91b9-894f-44d6-815c-78349491e16f
Internal identifier
:
T150494
Type of procedure
:
Negotiated without prior call for competition
2.1.1 Purpose
Main nature of the contract
:
Services
Main classification
(
cpv
):
73111000
Research laboratory services
2.1.2 Place of performance
Anywhere
2.1.4 General information
Legal basis
:
Directive 2014/24/EU
5. Lot
5.1 Lot technical ID : LOT-0000
Title
:
High throughput transcriptomics for the EFSA TXG-MAP project
Description
:
In the context of the project Translational quantitative Toxicogenomics mechanism-based AOP mapping for human NAM-based risk assessment (TXG-MAP) project funded by the European Food Safety Agency (EFSA) we require fast and affordable high throughput transcriptomics analysis.
Internal identifier
:
T150494
5.1.1 Purpose
Main nature of the contract
:
Services
Main classification
(
cpv
):
73111000
Research laboratory services
5.1.2 Place of performance
Anywhere
Additional information
:
5.1.6 General information
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA)
:
no
5.1.12 Terms of procurement
Information about review deadlines
:
Representations can be made within 20 days of publication of this prior information notice.
5.1.15 Techniques
Framework agreement
:
Framework agreement, without reopening of competition
Information about the dynamic purchasing system
:
No dynamic purchase system
5.1.16 Further information, mediation and review
Review organisation
:
Rechtbank Den Haag
-
Information about review deadlines
:
Representations can be made within 20 days of publication of this prior information notice.
Organisation whose budget is used to pay for the contract
:
Universiteit Leiden
Organisation executing the payment
:
Universiteit Leiden
Organisation signing the contract
:
Universiteit Leiden
6. Results
Maximum value of the framework agreements in this notice
:
1 800 000
Euro
Approximate value of the framework agreements
:
1 800 000
Euro
Direct award
:
Justification for direct award
:
The contract can be provided only by a particular economic operator because of an
absence of competition for technical reasons
Other justification
:
In the context of the project Translational quantitative Toxicogenomics mechanism-based AOP mapping for human NAM-based risk assessment (TXG-MAP) project funded by the European Food Safety Agency (EFSA) we require fast and affordable high throughput transcriptomics analysis. The TXG-MAP project is part of the call on NAM projects in the areas of AOP development and transcriptomics for risk funded by EFSA. In this framework, we are aiming to advance the development and application of mechanisms-based assessment in non-animal approaches. This project involves 7 consortium partners from academia, regulatory agencies and medical centres across the Netherlands and Germany. The project also collaborates extensively with the U.S. NIEHS/National Toxicology Program and the U.S. Environmental Protection Agency. The ultimate aim of the project is to provide a user-friendly tool to incorporate a mechanism-based assessment for EFSA to be applied in their routine evaluation procedure of the safety of substances. A strategy to gain insight in the mode-of-action of chemicals is the application of gene expression profiling. In the context of safety testing this is named toxicogenomics. A limiting aspect for toxicogenomics has been the costs per sample to establish transcriptome information, either through microarray analysis or with full RNAseq. These high costs have been preventing large scale concentration-response analysis. In previous projects coordinated by Universiteit Leiden (Eu-ToxRisk, RISK-HUNt3R) or where Universiteit Leiden act or acted as partner (IMI TransQST, eTRANSAFE, DISCERN, PARC) Universiteit Leiden used the TempOseq technology provided by Bioclavis that is fast, cheap and robust, and built models based on toxicogenomics data for several non-animal test systems. In the EFSA TXG-MAP project, we have planned to expand the existing models to more non-animal test systems and for that to the coordinator ( Universiteit Leiden) has been allocated all the costs for the high throughput transcriptomics to have control over the samples that are analysed by transcriptomics. Several partners in EFSA TXG-MAP will generate high throughput toxicogenomics for various non-animal approaches, that need to be compared with each other and with the pre-existing models, hence one technology should be used. All partners send samples to Universiteit Leiden that is therefore paying all bills. There are several pre-conditions for the selection of high throughput transcriptomics technology: • Direct collaboration with US partners in the chemical safety testing sciences at NTP and EPA, by aligning the HTTr technology, to allow direct international collaboration. • Assay set up that allows low cell number (for expensive assays such as microphysiological systems/Organon-a-Chip) • Direct lysis of cells for mRNA extraction, without the need for RNA isolation (to safe costs and speed) • Flexible set up for defining validated gene panels for targeted RNA sequencing • No need for extensive alignment bioinformatics • One read per gene, ensuring that no loss of reads based on large genes • Barcoding of thousands of samples, allowing pooling of samples to safe on sequencing costs • Attenuation of highly abundant genes to have cost effective sequencing • Servicing of sequencing by CRO company • Compliance with existing datasets and models previously acquired in the context of other projects by Universiteit Leiden • Ability to sequence FFPE samples stored for up to 10 years and low input, without RNA isolation 2. TempOseq technology as solution for EFSA TXG-MAP project. The TempOseq technology developed by Biospyder and serviced by the daughter company Bioclavis in Europe meets all of the above needs (see SoleSource document). It allows highly sensitive HTTr. Does not require RNA isolation and attenuation of highly abundant genes to to reduce the consumption of sequencing reads by highly expressed genes. It is cost effective due the targeted sequencing and one read per gene. It allows pooling of multiple samples making pooled sequencing feasible. Design of selected gene panels is possible. TempOseq allows easy bioinformatics analysis and is pre-processed by Bioclavis. The TempOseq technology is patented by Biospyder in the US. EFSA TXG-MAP has successfully optimized the sampling and toxicogenomics for all of the >different test systems for TempOseq application. The TempOseq technology has proven highly compatible with the needs of EFSA TXG-MAP. The EFSA TXG-MAP project has from its beginning been focussing on the TempOseq technology of Biospyder. This technology is being serviced by Bioclavis in Scotland. The TempOseq technology has been developed by Biospyder in close collaboration with the US NIEHS/NTP and the US EPA.
6.1 Result lot ldentifier : LOT-0000
Framework agreement
:
Maximum value of the framework agreement
:
1 800 000
Euro
Re-estimated value of the framework agreement
:
1 800 000
Euro
6.1.2 Information about winners
Winner
:
Official name
:
BioClavis Ltd
Tender
:
Tender identifier
:
T120687
Identifier of lot or group of lots
:
LOT-0000
Value of the tender
:
1 800 000
Euro
The tender was ranked
:
no
Subcontracting
:
No
Contract information
:
Identifier of the contract
:
Contract
Title
:
Framework Agreement
Date on which the winner was chosen
:
29/04/2025
Information about European Union funds
Identifier of EU funds
:
GP/EFSA/ED/2022/01
Further details of EU funds
:
EFSA call GP/EFSA/ED/2022/01: NAM projects in the areas of AOP development and transcriptomics for risk assessment
Organisation signing the contract
:
Universiteit Leiden
8. Organisations
8.1 ORG-0001
Official name
:
Universiteit Leiden
Registration number
:
27368929
Postal address
:
Kolffpad 1
Town
:
Leiden
Postcode
:
2333BN
Country subdivision (NUTS)
:
Agglomeratie Leiden en Bollenstreek
(
NL337
)
Country
:
Netherlands
Contact point
:
Govert Schipperheijn
Telephone
:
+31715273304
Roles of this organisation
:
Buyer
Organisation signing the contract
Organisation whose budget is used to pay for the contract
Organisation executing the payment
8.1 ORG-0002
Official name
:
Rechtbank Den Haag
Registration number
:
82946175
Department
:
Civiel
Postal address
:
Postbus 20303
Town
:
Den Haag
Postcode
:
2500 EH
Country subdivision (NUTS)
:
Agglomeratie ’s-Gravenhage
(
NL332
)
Country
:
Netherlands
Contact point
:
Informatie
Telephone
:
+31883622200
Roles of this organisation
:
Review organisation
8.1 ORG-0003
Official name
:
BioClavis Ltd
Size of the economic operator
:
Large
Registration number
:
284427679
Postal address
:
201 Dumbarton Road
Town
:
Clydebank
Postcode
:
G81 4XJ
Country subdivision (NUTS)
:
East Dunbartonshire, West Dunbartonshire and Helensburgh & Lomond
(
UKM81
)
Country
:
United Kingdom
Telephone
:
+441412865100
Roles of this organisation
:
Tenderer
Winner of these lots
:
LOT-0000
Notice information
Notice identifier/version
:
81fab717-83cc-4f45-bca0-0f9a95ce56bf
-
01
Form type
:
Direct award preannouncement
Notice type
:
Voluntary ex-ante transparency notice
Notice dispatch date
:
07/05/2025
08:56 +00:00
Notice dispatch date (eSender)
:
07/05/2025
08:57 +00:00
Languages in which this notice is officially available
:
English
Notice publication number
:
00296877-2025
OJ S issue number
:
89/2025
Publication date
:
08/05/2025