[Withdrawn] Guidance for industry on evaluations of diagnostic products for coronavirus (COVID-19)
Updated 14 April 2020
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This publication is available at https://www.gov.uk/government/publications/covid-19-evaluation-of-commercially-available-diagnostic-products/guidance-for-industry-on-evaluations-of-diagnostic-products-for-coronavirus-covid-19
The Department of Health and Social Care evaluates approaches from industry to encourage diagnostic and other scientific innovation.
PHE and other agencies have stood up a network of validation labs to support the rapid validation of new tests and testing kit and consumables.
This programme will provide a single entry-point for all communication from industry and involves a two-stage rapid evaluation process, which is as follows.
Stage 1
When we receive a submission of information on a diagnostic test or other product, we will undertake a systematic evaluation of the information provided to reach a decision on whether to progress to stage 2.
This will be communicated to submitters within 1 week and be based on:
- a desk-based evaluation of test performance
- whether the product does or does not have the potential to meet an unmet need for patient care and public health or be taken up by a number of laboratories in the UK that currently have no testing capabilities
- whether the product does or does not conform to any relevant published guidance
We will also consider the supply chain and availability of reagents and equipment together with cost. It is important that we focus on clinical need.
It will not be possible to reconsider the outcome of our decision unless a fundamentally new test is proposed by the same company.
Stage 2
For tests that are accepted into the programme following the stage 1 review process, evaluation will proceed through a testing framework.
We will contact the relevant parties to discuss how we will apply this framework, including plans for evaluation and timelines.
Contact
Approaches from companies with diagnostic products they want to be considered for evaluation should use our dedicated online form at www.gov.uk/coronavirus-testing.