Invitation to tender for the provision of a Next Gen Sequencing Platform for the Cancer Molecular Diagnostics Department within St James’s Hospital Dublin

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1. At a glance

2. Scope of Work

The Contracting Authority (CA), St James’s Hospital (SJH), seeks a provider for a Next Generation Sequencing (NGS) Platform for its Cancer Molecular Diagnostics Department. The contract encompasses the provision and support of reagents and associated equipment. The laboratory aims to expand its testing repertoire and focus on developing NGS-based diagnostic methods.

The NGS instrument must have the capacity to process small, focused 30-gene smMIP-based panels up to 200-gene panels. These panels will be performed on both tumour and matched blood samples. The laboratory also requires expansion capacity for developing cfDNA testing using panels of up to 500 genes. The proposed sequencer will operate alongside the current diagnostic NGS platform (Ion Torrent S5 sequencers with Oncomine/AmpliSeq/smMIP library prep), with potential for assay migration between platforms over time. Bioinformatic and library preparation solutions are explicitly excluded from this tender.

Key Requirements and Volumes:

• Minimum Instruments: A minimum of two identical instruments are required, funded by reagent purchase, to support routine diagnostic work and ensure laboratory workflow resilience against single points of failure.
• Development Instrument: An option exists to purchase an additional identical instrument for development purposes, subject to funding availability and as a capital purchase.
• Current Platform Compatibility: The proposed solution must be compatible with the legacy smMIP platform without modification of adapter sequences.
• Workload (Past 3 Years):
• 2023: 6,341 NGS-based methods
• 2024: 7,003 NGS-based methods
• 2025: 7,589 NGS-based methods
• Expected Workload (Next 5 Years):
• Small panels (3Gb per sample): 3,500 tests per year (Years 1-5)
• 200-gene panels (20 Gb per sample): 2,500 (Year 1), 2,750 (Year 2), 3,000 (Years 3-5)
• cfDNA <100 gene: 100 (Year 1), 125 (Year 2), 150 (Year 3), 175 (Year 4), 200 (Year 5)
• Warranty: Maintenance costs must include a minimum of a 1-year warranty. A 5-year warranty and comprehensive service are also required.
• Installation Support: A minimum of one year of free support following installation of the analyser is required.

3. Background & buyer context

St James’s Hospital (SJH), established in its modern form in 1971, is the largest acute general hospital and academic teaching hospital in the Republic of Ireland. Located in Dublin, it operates on a sixty-acre site and provides comprehensive medical and surgical services across numerous specialties, often at regional or national levels. The hospital has approximately 1000 beds and 4,500 staff, functioning as a major acute care, teaching, and research centre. Its clinical services are organised into Clinical Directorates. SJH has strong educational linkages with the University of Dublin (Trinity College), including the Trinity Health Sciences Centre.

The Cancer Molecular Diagnostics laboratory currently utilises standard PCR, real-time PCR, and Next Generation Sequencing (NGS) for diagnosis and management of haematological and solid malignancy. To meet increasing demand and expand its testing capabilities, the laboratory is focusing on developing its NGS-based diagnostic methods. This tender is driven by the need to acquire a new NGS instrument to support this growth and enhance the diagnostic services offered to clinical users. The current procurement process is managed by the Next Gen Sequencing Platform Procurement Steering Group.

4. Eligibility & selection criteria

Bidders must meet the following minimum requirements to be considered:

• Turnover requirement: A minimum average annual turnover of €750,000 over the past three years, evidenced by an objective source confirming a sound financial position.
• Insurance:
• Employer's Liability: €13 million
• Public Liability: €6.5 million
• Products Liability: €6.5 million
• Professional Indemnity: €6.5 million
• Motor Insurance: Third Party Property Damage - €2.6 million; Third Party Personal Damage - Unlimited.
• Insurance must be held from the date of contract until completion of the job, with specific durations noted for Product Liability (6 years after completion) and Public Liability (completion of the job).
• Certifications:
• Manufacturing of the tendered product must be accredited to ISO 9001, ISO 13485, or ISO 17664, or a similar independently accredited certificate of quality.
• All equipment and test validation must comply with accreditation requirements as per ISO 15189:2012 (Medical laboratories — Particular requirements for quality and competence).
• Past experience: Not specified for this tender.
• Personnel: Not specified for this tender.
• Geographic / facility constraints: Not specified for this tender.

5. Award criteria & scoring

The contract will be awarded to the Tenderer who submits the Most Economically Advantageous Tender Overall (MEAT). The evaluation process combines cost proposals with qualitative scores.

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