Demonstration of analytical and clinical performance is to be conducted by the suppliers.

The ‘analytical performance’ of the developed oncNGS solution will need to be demonstrated fully in phase 2.

With respect to ‘clinical validation’, the oncNGS consortium is aware that a full validation including a prospective clinical trial demonstrating clinical validation and utility is not feasible within the timeframe and budget of the PCP and would resort more on an eventual follow-up PPI.

‘Clinical validation’ consists of demonstrating clinical performance on specimens both at the suppliers level and at the buyers sites. More specifically, the suppliers are asked to demonstrate clinical performance and feasibility of the oncNGS solution on a set of markers already in phase 2.

In phase 3, suppliers can complete their clinical performance and feasibility for the rest of the markers and a prospective clinical feasibility of the use of the solution will be tested at the buyers facilities using their own samples. Thus, the consortium wishes to corroborate the clinical performance of the provided oncNGS solutions only in phase 3.

With respect to the ‘clinical performance assessment’, tenderers are required to present their strategy in the technical offer. Additionally oncNGS buyers are open for discussing modalities of their involvement with the suppliers in due time, taking into considerations the limits and constraints set out by the relevant pre-commercial procurement terms and conditions.

Please also refer to the answer given to question number 28.

Tenders can be submitted either individually or in consortium with other economic operators (under no circumstances it will be allowed to any natural or legal person to submit more than one bid).

In agreement with the Guidance PCP procurement documents for the H2020 Programme (Version 2.1 07 January 2020), it is imperative that more than 50% of the R&D activities that are justified by the partnership are performed in EU Member States or Horizon 2020 associated countries.

For further clarification of the term “51% of the R&D activities”, is calculated as the part of the total monetary value of the oncNGS contract that is allocated to activities performed in the EU Member States or in other countries associated to Horizon 2020, delivered within the context of oncNGS framework agreement and contracts, thus NOT the overall activities of the supplier or the consortium of suppliers in general.

The 51% of R&D is to be performed in the EU Member States or in other countries associated to Horizon 2020 for each individual phase in the PCP and thus for the overall framework agreement.

A partner match page has been opened on the oncNGS website where request for partners can be announced. oncNGS secretariat will manage the online noticing of the request. If a supplier wishes to utilize this facility, please inform the oncNGS secretariat by the contact form of this website.

Also, note that it is possible to subcontract to third parties not more than 50% of the activities in each phase.

Suppliers that have obtained a contract for a particular phase of the oncNGS PCP have opportunities to interact with the oncNGS buyers (and eventually also the supporting entities) at regular intervals along the phases. These interaction moments will be clearly outlined within the Call for Tender as milestones in the process.

Questions to the oncNGS consortium can be forwarded at all time during the project through the contact facility within the oncNGS website.

The EC-IVD will be fully in place by the end of the oncNGS project and any oncNGS solution to be used in routine diagnostics at that moment will have to fully comply with the specifications of the EC-IVD regulation.

In agreement with CfT, during Phase 3 contract, oncNGS suppliers are required to submit as deliverable a clear description of how they intend to comply with this regulation when placing the oncNGS solution on the market.

Please refer also to the answer to question 27 and 29.

The IP ownership and obligations will be set forth in detail in the Call for Tender documents and Contract Notice. In agreement with the Guidance PCP procurement documents for the H2020 Programme (Version 2.1 07 January 2020):

• the selected operators (R&D service providers) retain ownership of the intellectual property rights (IPRs) that they generate during the PCP (together with the responsibility and the costs for protecting those IPRs) and are able to use them to exploit the developed solutions beyond the procurers;
• the buyers group has the right to:
  • access results, on a royalty-free basis, for their own use
  • grant (or to require the contractors to grant) non-exclusive licences to third parties to exploit the PCP results under fair and reasonable conditions (without the right to sub-license)
• the buyers group has the right to require the contractors to transfer ownership of the IPRs if the contractors fail to comply with their obligation to commercially exploit the results or use the results to the detriment of the public interest (including security interests).

oncNGS consortium is fully aware that the reimbursement of the oncNGS solution through the local healthcare systems (HCS) may differ considerably in the different countries. Not only are the reimbursement fees for molecular diagnostics at this point in time different, also the treatments and care pathways can be different what may impact positioning of the use of the oncNGS solution in the various HCS.

It is NOT the purpose of the oncNGS PCP to provide a one-fit-all solution for the real-life implementation of the oncNGS solution in each HCS.

oncNGS PCP challenges innovative players on the market, via an open, transparent and competitive process, to develop new solutions for a technologically demanding mid- to long-term challenge that is in the public interest and requires new R&D services

However, we will request the suppliers to provide the Buyers Group a clear indication on how they foresee the placing on the market of their solution what will include to some extent a price indication. It remains at the full liberty of the suppliers how they wish to market their solution but the oncNGS buyers have clearly indicated that a sustainable local utilization of the oncNGS solution in their laboratory facilities and local analyses of the sequence data is essential.

The oncNGS solution does not limit the scope of utilization to one particular NGS technology. Considering that the aim of the oncNGS PCP is to bring innovation to all patients, NGS technology should not be a limiting factor and preference will be given to compatibility with as many technologies as within the possibilities of the PCP timeframe and budget.

The oncNGS solution is indeed primarily aimed at being used in routine diagnostics in oncology. This does not mean that the solution should be deployable in any laboratory that wishes to perform complex NGS analysis in their laboratory. It is understood that the use of the oncNGS solution will require availability of not only suitable NGS infrastructures including IT infrastructures but also skilled personnel to perform, analyse, interpret and communicate the oncNGS results.

Nevertheless, the application of the oncNGS solution in other fields or domains can be foreseen and will be considered an asset to the oncNGS solution. One can especially think of the application of the oncNGS solution in basic research, clinical trials, and as reference for material assessment.

A concise conceptual proposal for deployment of the oncNGS solution within a broader scope (e.g. for basic research, clinical trials, …)  could be considered within the business case to be presented by the supplier. However, oncNGS will not demand any “Proof of Concept” of such deployment.

MRD is indeed a very interesting component in assessing the outcome of the treatment and an essential element in follow-up of cancer therapies. It is understood by the oncNGS consortium that applying MRD detection requires a substantially different approach than screening for genomic variation aiming to diagnose the cancer or to determine prognostic and/or predictive markers for therapeutic use.

The primary aim of oncNGS as presented at the OMC webinars is to develop a tool for diagnosis, prognosis, prediction, theranostic and the agnostic use in case patients have an advanced cancer. As such, the Call for Tender will address basically these three applications.

MRD detection could be an interesting secondary use of the solution and the oncNGS consortium would certainly welcome proposals from the suppliers on how to integrate MRD with the oncNGS solution for diagnosis, prognosis, theranostic or prediction. A sound conceptual approach may thus be considered as an interesting asset. However oncNGS Buyers do not expect though that within the timeframe and budget currently made available any practical aspects can be already developed as to MRD detection.

As indicated in the OMC webinars, the oncNGS solution is to be considered as an integrated solution. An Integrated Solution is a “result from the problem solving work process that integrates across two or more functions in a business or technology that is referred to as an enterprise to maximize financial value (e.g., sales and productions planning, etc.) as well as combined with complementary technologies such as robotics (e.g., driving, robotic surgery, etc.) to provide integrated solutions” (The Project Definition – for your project success!).

To translate this definition to our oncNGS project, we seek to develop oncNGS as covering our unmet need in assessing genetic variation in liquid biopsies from patients with an advanced solid or hematologic tumour by NGS.

To clarify further, the buyers will accept oncNGS single NGS panel containing all genes in a single chip, or several distinct panels (modular design) each containing a gene subset, as a response to the wetlab requirements. ‘Scalable’ includes the idea of a ‘modular’ approach.  The OncNGS consortium may consider acceptable a core panel with ‘must have’ and/or other genes deemed as high priority, the remaining genes being sequenced by additional module(s) that may be added on need. It is utterly important though to thoroughly consider the overall time of analysis, resources and costs for the wetlab step proposed in the oncNGS solution.

The selection criteria are defined in the Section 6 of the CfT together with the Exclusion, Compliance and Award criteria.

During the execution of the contracts, oncNGS suppliers are being monitored in agreement with the provisions set in Section 7 of the CfT and its Annex 7 and in agreement with the actual gene panels, analytical and clinical performance indicators and NICE TO HAVE requirements the Suppliers commits to deliver through its technical offer.

Experience in the field of the object of the contract will need to be demonstrated. The tenderer i.e. has to comply to the Exclusion, Compliance and Selection criteria as set out in Section 6 of the Call for Tender.

All the buyers in charge of running a clinical performance have already their own sequencing platforms. By the way it is considered relevant to remember that oncNGS PCP is an R&D service contract. The definition of services means that the value of the total amount of supplies covered by the contract must be less than 50 % of the total value of the PCP, from Phase 1 to Phase 3.

In case the Tenderer considers that a specific equipment is needed to provide oncNGS R&D services, it will need to justify it accordingly in its technical offer and enter the relevant biding unit price in its financial offer.

In agreement with the Guidance PCP procurement documents for the H2020 Programme (Version 2.1 07 January 2020), the total value of products offered in phase 1 respectively phase 2 must be less than 50 % of the value of the phase 1 respectively phase 2 contract and the total value of products offered in phase 3 must be so that the total value of products offered in all phases (1,2 and 3) is less than 50% of the total value of the PCP framework agreement.

All buyers in charge of running a clinical performance, independently of their sequencing platforms, commit to test the prospective feasibility of the at least one of the solutions using their own samples.

The suppliers will be required to install their oncNGS prototypes at the oncNGS pilot sites, provide all consumables for the wetlab analysis and operationalize the IT analytical and reporting tool at the oncNGS pilot site. Tenderers financial offer will include binding unit prices for all foreseeable items for the duration of the whole PCP (from Phase 1 to Phase 3).

Samples, personnel and sequencer equipment to handle the workflow will be provided by the oncNGS pilot sites. Permissions to install the oncNGS solution locally at the buyers ‘site will be taken on by together the oncNGS pilot sites.

For the clinical performance assessment, please refer to the answer to Question 1.

In agreement with the Guidance PCP procurement documents for the H2020 Programme (Version 2.1 07 January 2020), oncNGS is a pre-commercial procurement (PCP).

PCP means that public procurers challenge innovative players on the market, via an open, transparent and competitive process, to develop new solutions for a technologically demanding mid- to long-term challenge that is in the public interest and requires new R&D services.

PCP is explained in the PCP communication COM/2007/799 and the associated staff working document SEC/2007/1668. The R&D services can cover research and development activities ranging from solution exploration and design, to prototyping, right through to the original development of a limited set of ‘first’ products or services in the form of a test series. Original development of a first product or service may include limited production or supply in order to incorporate the results of field-testing and demonstrate that the product or service is suitable for production or supply in quantity to acceptable quality standards. R&D does not include quantity production or supply to establish the commercial viability or to recover R&D costs.[1] It also excludes commercial development activities such as incremental adaptations or routine or periodic changes to existing products, services, production lines, processes or other operations in progress, even if such changes may constitute improvements.

[1] See also Article XV(1)(e) WTO GPA 1994 and the Article XIII(1)(f) of the revised WTO GPA 2014.

The oncNGS consortium has listed the set of targets to be covered in the oncNGS solution. The complete list is available in CfT Annex 2 ‘The OncNGS Challenge Brief’ .

The solution should be able to analyse DNA and/or RNA and implicate the use of NGS analysis as the key technology .

There has been no restriction set as to the type of markers to be assessed. It is important though that sufficient evidence or clear justification for inclusion of a particular marker in the oncNGS solution is available.

OncNGS does not restrict to any particular NGS technology nor approach. It is however to be kept in consideration that oncNGS aims to be deployable at large in a sustainable way. A concise description of how the suppliers envisage such deployment within the Healthcare systems in the buyers’ countries will be requested.

Please refer as well to the answers to questions 6, 8 and 9.

oncNGS aims to produce a fully integrated solution to the buyers’ needs. For this, the buyers are convinced that all steps from analyte till final report need to be integrated in a single workflow by a single application. Thus, the complete workflows from pre-analytics through library preparation, gene panels, sequencing, bioinformatics to report for the clinician is to be considered as a whole.

Suppliers which cover only part of the oncNGS solution e.g. only the wetlab, and wish to bid for the oncNGS tender will need to complement their expertise to cover the full workflow envisaged by the oncNGS solution. (A partner match page has been opened on the oncNGS website where request for partners can be announced. oncNGS secretariat will manage the online noticing of the request. If a supplier wishes to utilize this facility, please inform the oncNGS secretariat by the contact form.)

OncNGS Buyers agree that up-to-date software applications for interpretation and reporting could be provided through secure, restricted-access, GDPR-compliant fully validated cloud services or equivalent. Suppliers are asked to explain their conceptual approach already in their offer and will require to provide full details in the Phase 1

The oncNGS PCP is an independently financed Horizon 2020 project and concise information on the general call can be found on the Cordis website. NGS diagnostics in 21st century oncology: the best, for all, at all times | oncNGS Project | H2020 | CORDIS | European Commission (europa.eu)

It is clear though that the final goal of the oncNGS PCP is to deliver a tool to the hospitals that brings a highly valuable innovation to patients with advanced cancer. All along the development of the oncNGS solution, it will be possible though within any legal constraints and upon agreement by all parties, to seek synergies with other initiatives that may be launched within the many future programs by the European Commission (e.g. Europe’s Beating Cancer plan, the Mission on Cancer, the 1+MillionGenomes project, the European Health Data Space initiatives, …).

The EU-UK withdrawal agreement from February 2020 dealt with the position of UK entities in ongoing funding programmes from the 2014-2020 MFF period (like Horizon 2020). The Brexit deal from end 2021 addressed the position of UK entities in new funding programmes from the 2021-2027 period (like Horizon Europe). The Brexit deal did not change the position of UK entities in ongoing funding programmes from the 2014-2020 MFF period (like Horizon 2020), as this was already agreed in the EU-UK withdrawal agreement.

So, yes, as long as projects are running under the Horizon 2020 programme, these projects have to keep referring to the February 2020 EU-UK withdrawal agreement. UK suppliers can bid and their R&D activities can account for the 51% obligatory R&D activities within the EU and Horizon 2020 associated countries.

OncNGS Buyers are fully aware that full local deployment of the complete oncNGS solution requires major investment as to IT infrastructure and logistics. OncNGS Buyers consider though that such option should be made available by the oncNGS supplier, well understood that the investments for operationalizing the local deployment is the burden of the buyer. When locally deployed, the oncNGS supplier should optimize the required RAM/CPU to fully operationalize the oncNGS solution in as much as possible though.

In addition, as correctly pointed out, if buyers do not wish to make the investment for locally installing the full oncNGS solution, a cloud service can be foreseen and the oncNGS supplier has to prove how such analysis can be performed in a secure way matching all required levels of data protection, privacy and security.

Thus, SUST.03 does not exclude cloud services nor does BIOINFOR.SUST.MAINT.01 exclude that IT investments could be major.

As to SUST.04, we also recognize that Bio IT tools are most easily upgradable trough a cloud service and can understand that for several buyers this option could suffice.

However, the buyers wish in addition that locally developed algorithms and obtained results can be combined/integrated in the oncNGS Bio Tools in a secured way. It is one of the challenges the oncNGS consortium wishes to put forward to the suppliers. The consortium welcomes the suppliers to propose options for such secure combination and integration.

The Evaluation of the tenders will be done in agreement with Section 6.6, the Annex 5 Awarding Criteria and Annex 6 Scoring Model for the Price of the Call for Tender.

As can be observed in the matrix, both cost and actionability are important but while actionability/coverage is estimated more important at the early stage and then is decreasing, price follows the reverse trajectory. This reflects the pathway from research to (commercial) deployment.

The oncNGS PCP aims at developing an integrated solution for predictive, prognostic and diagnostic analysis in liquid biopsies of solid tumours (including appropriate haematological indications) based on NGS technology. It is thus perfectly possible to develop ‘tailored’ panels to specific needs applying the overall standardized workflow of the oncNGS solution (sample, NGS, bioinformatics, interpretation & reporting). However we do request that suppliers develop the panels described in the Call for Tender (Pan-cancer oncNGS LB panel (=Panel 1) & Hemato/Lymphoma oncNGS LB panel (= Panel 2)). It is up to the supplier to decide whether to include the full coding sequence or just hotspots.

As to the scope of the panels, we have listed the required biomarkers that the buyers identified as important – these markers are considered important for p and could be used predictive, prognostic and diagnostic analysis and are primarily focused to routine actionability notwithstanding the opportunity for exploratory use.(e.g. clinical trials)

The nature of the variations to be covered for each of the biomarkers, or combination of biomarkers, is open to the suppliers to decide what should be included but should be justifiable by scientific argumentation – both omitting or adding decision elements.

Please also refer to the answer given to question 9.

English annotations meet the criteria.

The solution need to cover both, DNA and RNA.

oncNGS solution strives to have a high grade of automatization with a turn-around-time of 48h (= 2 working days).

And, as specified in WETLAB.USE.PERF.01, OncNGS solution turnaround time (for the entire diagnostic workflow (from nucleic acid to  molecular report)) is required to be 5-7 days maximum.

All Must Have criteria are required to be addressed in the tender. In principle any must have criterion failing to be addressed leads the tender not to meeting the minimal requirements and in principle to be excluded. Any ‘must have’ criterion failing to meet the Min Points renders the tender “not to meeting the minimal requirements” and in principle will be excluded.

Please refer to the answer to the question 26

The Technical Excellence score results summing up the scores achieved in all its subcriteria (from 1 to 6). In case the Technical Excellence is not meeting the Min Points, the tender will be excluded.

Please refer to the answer to the question 25

For clarification purposes, with ‘CE IVD compliant” oncNGS Buyers Group means that the proposed solution should be taking into consideration the requirements set forward by the CE IVD regulation, obtaining the certification is not a requirement though.

Please refer also to the answer to question 3 and 29

In agreement with CfT, during Phase 3 contract, oncNGS suppliers are required to submit as deliverable a clear description of how they intend to comply with this regulation when placing the oncNGS solution on the market.

As for Level I genes, if a supplier wants to omit any a clear argumentation would be given.

oncNGS Buyers Group opted for allowing modular/scalable organisation of the markers (see also updated commentary in question 9).

In principle, it is the supplier who has to perform the clinical validation.

For clarification, it is the supplier who has to organize the clinical performance assessment as outlined under phase 3 and in agreement with local/regional/national oncNGS Buyers regulations. OncNGS Buyers are committed to support the suppliers contracted under phase 3 in this step of the PCP, taking into considerations the limits and constraints set out by the relevant pre-commercial procurement terms and conditions.

Please refer to the answer given to question number 1.

Considering that the implementation of the CE-IVD is postponed to 2027, suppliers will have time to  pursue CE-IVD certification after accomplishment of the oncNGS PCP.

Please refer also to the answer to question 3 and 27.

In agreement with CfT, during Phase 3 contract, oncNGS suppliers are required to submit as deliverable a clear description of how they intend to comply with this regulation when placing the oncNGS solution on the market.

Considering that the implementation of the CE-IVD is postponed to 2027, suppliers will have time to  pursue CE-IVD certification after accomplishment of the oncNGS PCP.

Please refer also to the answer to question 3, 27 and 29.

In agreement with CfT, during Phase 3 contract, oncNGS suppliers are required to submit as deliverable a clear description of how they intend to comply with this regulation when placing the oncNGS solution on the market.

In preparation of the ‘Technical, analytical and clinical performance validation of the oncNGS solution with clinical samples in Supplier’s sites and real clinical settings’, taking place during Phase 3, specific provisions regarding the governing of the protection of data and of data concerning health will be provided to ensure compliancy with the European General Data Protection Regulation (GDPR) and with any other law and regulation applicable locally at the pilot sites.

Confirmed.

No.

The Background and Sideground has to be shared royalty free as stated in article 13.3.1 of the Framework Agreement, regarding the execution of the Framework Agreement, which includes the execution of the Specific Contracts.

After the execution of the Framework Agreement, there is the possibility that some IPR’s of Background and/or Sideground can be given under Fair and Reasonable Conditions, which can be subject of negotiation between Parties and/or third parties.

Regarding the Results article 13.3.2 applies.

Yes.

It is possible under the duration of the Framework Agreement and even after cf. article 3.5 of the Framework Agreement.

In that case a juridical procedure could be initiated based on article 29 of the Framework Agreement.

This is only regarding the Results, not regarding any former IPR. For example to elaborate further R&D if necessary (and to make it possible that the developed product can be commercialized). Fair and reasonable conditions apply.

Falls under the scope of “legitimate business interests”.

The price below 1500 € is intended price per sample and this price includes all the steps covered by the oncNGS solution from analyte to report. Data storage is not included and is to covered by the buyer.

For clarification, the buyers understand that price is a very relative indicator and susceptible to many factors out of the responsibility of the suppliers.

OncNGS Buyers wish though that the suppliers provide them with different business models that address their business case under various conditions (e.g. research vs routine; single sample, low, medium, high throughput application) and not necessarily depend on the price per kit/sample.

FOXO 1 gene is NICE TO HAVE in the both panels.

P53 gene is MUST HAVE (both, Hemato and pan Cancer panel)

RAF1 gene is NICE TO HAVE in the pan Cancer panel.

The Consortium prefers that any consumables such as plastic tubes, reagents can be purchased from different brands, not from a single vendor.

This depends of the specific situation, but it is possible that the publication of specific summaries can be postponed or information of the publication can be removed when this implies that IP rights would be jeopardized. The Buyers Group will therefore consult the Supplier. Nevertheless the other provisions regarding the distribution of the results and confidentiality (see Article 12 of the Framework Agreement) have to be taken into account.

Yes respecting the standard terms for patenting.

During the tender phase, in agreement with the CfT, in case Tenderers are required to provide the Lead Procurer with information relating to commercial relationship or licenses with the third parties and that are confidential, Tenderers must, when providing such information, clearly identify the specific sections of their Tender containing such information and specify the reasons for its confidentiality or commercial sensitivity.

During the contract execution, in agreement with the Framework Agreement, in case Suppliers are required to provide the Lead Procurer with information relating to commercial relationship or licenses with the third parties and that are confidential, the Parties shall keep confidential any data, documents or other material (in any form) that is identified as confidential at the time it is disclosed. This applies during the implementation of the Framework Agreement and Specific Contracts and up to four (4) years their end. In Article 12 of the Framework Agreement it is specified in what cases the confidentiality obligations cease to apply.

Any information that is important for the Buyers in assessing the aptness of the elements of the offer is to be provided including the business case, IP situation, IVD vision, unpublished patents, research papers, … Any of those info that the Supplier considers confidential can be transferred labelled ‘Confidential’ and will be handled in such manner by the buyers.

The PCP communication COM/2007/799 specifies that “In pre-commercial procurement the public purchaser chooses not to reserve the R&D results exclusively for its own use . (…), pre-commercial procurement is an approach to procuring R&D services which involves risk-benefit sharing and does not constitute State aid”.

Consequently, in pre-commercial procurement:

• the public purchaser does not reserve all the results and benefits of the development (including Intellectual Property Rights or IPRs) exclusively for its own use,
• the public purchaser shares with a company participating in the pre-commercial procurement the risks-benefits according to market conditions
• any R&D benefit shared by the public purchaser should be compensated by the company to the public purchaser at market price. This can be done through, for example, a price reduction compared to exclusive development cost that reflects the market value of the benefits received and the risks assumed by the company

As explained in the form F the Tenderer is required to provide for each cost element (personnel, materials and equipment, subcontracting and other costs) and for each Phase the Virtual Price (price that they would have quoted if all Intellectual Property Rights, including the ownership of results under the PCP, would be retained by the Buyers Group and the Suppliers would not have the possibility to exploit the results) and the Actual Price (price, which includes a financial compensation (i.e. a discount) taking into account the fact that the Suppliers keep ownership of the IPR of their solutions and can commercially exploit the results).

Please read carefully Section 2 of Form F for further clarification.

In principle the Buyers Group would not do that. But it is not excluded that it could be a specific case. But again, the license has to be granted under “Fair and Reasonable Conditions” whereby the specific circumstances can be taken into account. Please note as well that other provisions, such as for example the confidentiality clauses, apply.

See the answer on Question 43.

“Fail to comply with their obligation to commercially exploit the results” means not meeting any of the criteria that the Buyers have put forward for the oncNGS solution including respecting the price, scope, quality and availability on the market. But also when a Supplier does not complies with their own business and commercialization plan as provided in the Tender.

See definition of Result in the Framework Agreement.

Any information that is important for the Buyers in assessing the aptness of the elements of the offer is to be provided including the business case, IP situation, IVD vision, unpublished patents, research papers, … Any of those info that the Supplier considers confidential can be transferred labelled ‘Confidential’ and will be handled in such manner by the buyers.

Any information that is important for the Buyers in assessing the aptness of the elements of the  offer is to be provided including the business case, IP situation, IVD vision, unpublished patents, research papers, … Any of that information that the Supplier considers confidential can be transferred labelled ‘Confidential’ and will be handled in such manner by the buyers.

Yes.

If buyers do not wish to make the investment for locally installing the full oncNGS solution, a cloud service can be foreseen and the oncNGS supplier has to prove how such analysis can be performed in a secure way matching all required levels of data protection, privacy and security.

oncNGS Buyers also recognize that Bio IT tools are most easily upgradable trough a cloud service and can understand that for several buyers this option could suffice. However, the buyers wish in addition that locally developed algorithms and obtained results can be combined/integrated in the oncNGS Bio Tools in a secured way. It is one of the challenges the oncNGS consortium wishes to put forward to the suppliers. The consortium welcomes the suppliers to propose options for such secure combination and integration, not a priori excluding cloud solutions.

In agreement with the CfT, OncNGS buyers some elements in the interpretation workflow cloud services can be offered solely in case oncNGS supplier proves how such analysis can be performed in a secured way matching all required levels of data protection, privacy and security.

The buyers wish the market to develop a solution for them on comprehensive cancer profiling as outlined in the tender. All buyers are indeed interested to apply this technology in their premises for their routine diagnostic testing and research.

Please refer to the commentary in question 50.

The buyers wish the market to develop a solution for them on comprehensive cancer profiling as outlined in the tender. All buyers are indeed interested to apply this technology in their premises for their routine diagnostic testing and research.

The buyers recognize the complexity in addressing the required versatility and scalability and enabling the testing of a variable number of samples within a single run (to the extreme only one sample in a run) maintaining consumable cost per sample low and similar, and preventing undue waste of reagents and resources in case of low-throughput runs. It is however the strong opinion of the Buyers that such option would greatly benefit the outreach and use of the oncNGS technology within the different diagnostics labs, especially those who support healthcare facilities with moderate to low number of cases.

For this, the tender stipulates that ideally the solution would be allowing to run a single sample on a particular chip, while safeguarding that not all reagents foreseen for the whole chip are being consumed by this run. If e.g. such partitioning would be possible, the overall cost of the chip would not be affected.

Tenderers are reminded to address all MUST HAVE requirements together with the Sustainability requirements aligning their business plan and strategy with Buyers business case.

The modifications in the new Call for tenders are visible (in purple) in the document below. This technical document shows oncNGS consortium alignment with the industry and the progresses the consortium did to boost a wider interest from the industry and the SMEs in order to address oncNGS unmet needs by offering more flexibility to the market to come up with the R&D industry feels more comfortable to offer.

Technical demand & market alignment of the oncNGS Call for tenders compared version of the oncNGS tender documentation

Acrobat reader is authorized. See the manual « How to submit an electronic tender? » on the procurement platform.  From page 8 to 11 it mentions the signature of the submission report. See also on page 10 point 4.4.2 the explanation concerning 3^rd party method signature (using for example Acrobat).

The tenderer must prove that he has at least three members that have over five years of experience in research and development in the relevant field of the PCP, to research and develop a solution to oncNGS challenge consisting in the provision of e.g. (1) efficient molecular DNA/RNA profiling of tumour-derived material in liquid biopsies by means of (2) pan-cancer tumour marker analysis kit including NGS analysis integrated with (3) an ICT decision support system including analytical test interpretation and reporting.
If the tenderer is a consortium, the experience can rely on the consortium as a whole. In this case, as specified in Section 4.2.2., a joint Tender must specify the role, qualification and experience of each member of the consortium.

Prior experience with Commercial Procurement or applying for other official tender is not required. Competitive successful application (award of) of grants and commercial projects is important. In this case, the Tenderer should provide a list of references/previous-ongoing projects which reflect his competence to provide R&D services (projects should be ongoing or completed in the past three years).

This requires a statement from a financial institution that you have evidence of sound financial standing and consequently you are in the position to make the necessary investments for the project. The bank has to declare, for instance, the availability of the necessary amounts in your favour or that they are likely to provide you with credit in case you are awarded with oncNGS contract, etc.
If the tenderer is a consortium the financial capacity can rely on the consortium as a whole and it is not necessary to prove them for each individual member of the consortium.
The Tenderer can also use the capacity of another entity/s to prove its solvency, evidence of that, such entities will place at the Tenderer’s disposal the necessary resources for the execution of the contract shall be provided by means of the declaration signed by all the parties.

It is sufficient that one party delivers the statement but in that case the parties of the consortium not delivering the document will use the capacity of the first party and the conditions written down in the CfT document will apply.

To date, a solution matching all requirements set by the oncNGS tender is not available on the market.  Any proposed solution by the suppliers can build on prior expertise and clearly demonstrate where additional R&D services are required from their side to cover the unmet need set by oncNGS buyers.

The tender is NOT sequencing platform dependent. To date, three platforms ae commonly used: Illumina, Thermo fisher and Nanopore. Suppliers should consider any of these platforms (see also question 6 of this FAQ).

The oncNGS consortium is not allowed to have access to any submission before the call for tender deadline. However the tenderer can still see and change its own offer before the closing date. After the call for tender deadline, the tenderer can no longer make changes to its offer and the offer will be checked for its conformity and will be evaluated. We also make mention of point 5.2.3 of the CfT document where a provision is foreseen regarding irregularities and non-compliancies. We remind that the Lead Procurer is not obliged to ask the tenderer for a regularization of its tender.

After the offers will be received, an evaluation will take place and afterwards the results of the evaluation will be communicated to the participants. There is an indicative timeline in the Call for Tender document (see Annex 4), normally it would require up to sixty days after the closing date.