Provision of Non-Invasive Pre-Natal Testing Service

Published date: 17 December 2024

Contract summary

Industry

Health services - 85100000

Location of contract

SW17 0QT

Value of contract

£2,000,000

Procurement reference

CF-2756700D0O000000rwimUAA

Published date

17 December 2024

Closing date

20 January 2025

Closing time

1pm

Contract start date

1 December 2025

Contract end date

30 November 2027

Contract type

Service contract

Procedure type

Open procedure (above threshold)

Contract is suitable for SMEs?

Yes

Contract is suitable for VCSEs?

No

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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.

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More information

Additional text

To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal https://health-family.force.com/s/Welcome.

Should Tenderers have any queries, or having problems using the portal, they should contact Helpdesk at:

Phone: 0800 9956035

E-mail: support-health@atamis.co.uk

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How to apply

Follow the instructions given in the description or the more information section.

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About the buyer

Contact name

Charlotte Choules

Address

Blackshaw Road
Tooting
SW17 0QT
GB

Email

charlotte.choules@stgeorges.nhs.uk

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