Section one: Contracting authority
one.1) Name and addresses
St George's University Hospitals NHS Foundation Trust
Blackshaw Road, Tooting
London
SW17 0QT
Contact
Charlotte Choules
charlotte.choules@stgeorges.nhs.uk
Country
United Kingdom
Region code
UKI - London
Internet address(es)
Main address
Buyer's address
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://health-family.force.com/s/Welcome
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://health-family.force.com/s/Welcome
Tenders or requests to participate must be submitted to the above-mentioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
https://health-family.force.com/s/Welcome
one.4) Type of the contracting authority
Other type
NHS
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Provision of Non-Invasive Pre-Natal Testing Service
Reference number
C319255
two.1.2) Main CPV code
- 85100000 - Health services
two.1.3) Type of contract
Services
two.1.4) Short description
The St George’s Antenatal Fetal Evaluation (SAFE) test is a Non Invasive Prenatal Testing (NIPT) service based at St George’s University Hospitals NHS Foundation Trust, screening for Down’s, Edwards’ and Patau’s syndromes, in line with UK National Screening Committee (UKNSC) recommendations and NHS England requirements. In some instances, fetal sexing is performed in addition to the main trisomy’s. The SAFE test has been set up as a collaboration between the Fetal Medicine Unit and the St George’s Genomics Service, which is a UKAS accredited medical laboratory. The service provides NIPT to approximately one third of the NHS maternity services in England and several private clinical services performing 4,000-5,000 tests annually.
This invitation to tender gives the requirement to supply a complete laboratory test setup including reagent test kits for NIPT, all equipment, associated software and LIMS and equipment servicing. The test should be commercially available and CE marked for In Vitro diagnostic use ideally compliant to ISO13485. It should detect aneuploidy of chromosomes 13, 18 and 21 and be able to determine fetal sex within the specified sensitivity and specificity thresholds as a minimum requirement.
The supplier must provide reagents, software and protocols sufficient to produce an end result on suitable equipment designated by the supplier. Resulting data must be clearly reportable and be usable by The SAFE Test personnel in a flexible and secure manner.
The service must be provided to diagnostic standards, incorporating a complete CE/IVDD compliant workflow, to ensure data can be used for clinical interpretation. Samples must be analysed within the given timeframe, data must meet the minimum specified requirements and results issued in a customisable and easily interpretable format.
The majority of samples processed are commissioned by NHSE with a contract running until March 2026. In the event St George’s is not re-procured by NHSE to provide this service beyond this point, it is likely that the service may have to terminate its contract with the supplier.
two.1.5) Estimated total value
Value excluding VAT: £2,000,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKI3 - Inner London – West
two.2.4) Description of the procurement
The St George’s Antenatal Fetal Evaluation (SAFE) test is a Non Invasive Prenatal Testing (NIPT) service based at St George’s University Hospitals NHS Foundation Trust, screening for Down’s, Edwards’ and Patau’s syndromes, in line with UK National Screening Committee (UKNSC) recommendations and NHS England requirements. In some instances, fetal sexing is performed in addition to the main trisomy’s. The SAFE test has been set up as a collaboration between the Fetal Medicine Unit and the St George’s Genomics Service, which is a UKAS accredited medical laboratory. The service provides NIPT to approximately one third of the NHS maternity services in England and several private clinical services performing 4,000-5,000 tests annually.
This invitation to tender gives the requirement to supply a complete laboratory test setup including reagent test kits for NIPT, all equipment, associated software and LIMS and equipment servicing. The test should be commercially available and CE marked for In Vitro diagnostic use ideally compliant to ISO13485. It should detect aneuploidy of chromosomes 13, 18 and 21 and be able to determine fetal sex within the specified sensitivity and specificity thresholds as a minimum requirement.
The supplier must provide reagents, software and protocols sufficient to produce an end result on suitable equipment designated by the supplier. Resulting data must be clearly reportable and be usable by The SAFE Test personnel in a flexible and secure manner.
The service must be provided to diagnostic standards, incorporating a complete CE/IVDD compliant workflow, to ensure data can be used for clinical interpretation. Samples must be analysed within the given timeframe, data must meet the minimum specified requirements and results issued in a customisable and easily interpretable format.
The majority of samples processed are commissioned by NHSE with a contract running until March 2026. In the event St George’s is not re-procured by NHSE to provide this service beyond this point, it is likely that the service may have to terminate its contract with the supplier.
two.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
two.2.6) Estimated value
Value excluding VAT: £2,000,000
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Start date
1 December 2025
End date
30 November 2027
This contract is subject to renewal
No
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: Yes
Description of options
Further 2 year optional extensions
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: No
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
20 January 2025
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Duration in months: 6 (from the date stated for receipt of tender)
four.2.7) Conditions for opening of tenders
Date
20 January 2025
Local time
1:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: Yes
six.4) Procedures for review
six.4.1) Review body
NHS South West London Integrated Care Board
120 The Broadway
London
SW19 1RH
Country
United Kingdom