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Concern was raised with us that companies providing genomic tests directly to consumers could profit...

Recommendation
Concern was raised with us that companies providing genomic tests directly to consumers could profit from supplying the tests while leaving the NHS to deal with consumers and their results following the test. Addressing this issue, representatives of several major direct-to-consumer testing companies indicated to our predecessor Committee their willingness to contribute to ongoing efforts to train genetic counsellors within the NHS. The Government should continue to explore, with Direct-to-consumer genomic testing 53 NHS England and NHS Health Education England, the opportunity for companies selling genomic tests directly to consumers to contribute to the costs of training genetic counsellors in the NHS.
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Government Response
Acknowledged
HM Government Acknowledged
Genomic counsellors play a key role in the genomic pathway and are an important but limited resource whose roles are first and foremost focused on activity commissioned by the NHS, covering referrals from NHS clinicians. As noted above, patients presenting to GPs after taking a DTC genomic test should be offered the NHS care which would otherwise have been offered (including referrals to genomic counselling services) regardless of their DTC result. NHS patients cannot access genomic counselling services in the NHS without a referral from an NHS clinician and a referral would not be made based solely on DTC genomic test results. Referrals to NHS genomic counselling services would only be made following the relevant NHS testing and/or assessment by an NHS clinician. Given this, DTC genomic tests are unlikely to be directly increasing demand for NHS genomic counselling services and therefore the NHS does not currently wish to seek contributions from DTC testing companies for the cost of training NHS genomic counsellors. Furthermore, if this recommendation were to be implemented, it would imply that NHS genomic counsellors could advise and support patients presenting with DTC genomic test results. There are several complex issues which would need to be addressed within the wider clinical pathway before this could be possible. This means that, at this stage, the NHS would not be able to implement this recommendation without additional funding and resource. For example: • Data and results generated from DTC genomic testing would need to be validated and accredited appropriately so that they can be used by the NHS (see recommendation 4). This may involve re-validation within the NHS and additional laboratory work, including interpretation and confirmatory testing in line with NHS clinical and scientific standards. This would incur additional costs for the NHS; • Allowing patients who have used DTC genomic tests to access NHS genomic counsellors would result in increased referrals to relevant services for patient management, including clinical genetics and oncology services, resulting in increased demand and pressure for these services; • Appropriate data and information infrastructure would need to be developed to support the incorporation of DTC genomic test results into the NHS, including the development of an appropriate laboratory information management system (LIMS). As it stands, the DTC genomic test results would not be compatible with the NHS’ data infrastructure. Despite the difficulties in implementing this recommendation immediately, the Health Education England National School of Healthcare Science (NSHCS) does have prior experience of enabling private sector companies to fund the cost of training staff providing NHS services, for example in fertility services. Therefore, the Health Education England Genomics Education Programme will work with NHS England, the NSHCS, the professions (Association of Genetic Nurses and Counsellors) and Government to explore the feasibility of implementing this recommendation in the longer term.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 4.9 yrs
Report published 22 Jun 2021