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Biobank pilot to be launched by MHRA to better understand genetics and medicines safety

A genetic ‘biobank’ will be launched on 1 June 2023 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to understand how a patient’s genetic make up can impact the safety of their medicines.

Known as the Yellow Card biobank, the biobank will contain genetic data and patient samples and be used by scientists to determine whether a side effect from a medicine was caused by a specific genetic trait.

A joint venture with Genomics England, the genetic research resource is the first of its kind to be launched by a drug safety regulator.

Operating alongside the MHRA’s existing Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices, the new venture forms part of a long-term vision for more personalised medicine approaches.

Targeted prescriptions

By understanding the underlying mechanism of an adverse drug reaction (ADR), it is hoped that pharmacogenetic testing strategies could be developed so that ADRs could be prevented rather than requiring a reactive approach.

In turn, this will enable doctors to target prescriptions so UK patients will receive the safest medication for them, based on their genetic makeup.

‘We are excited by the upcoming launch of the Yellow Card biobank, which demonstrates that we are at the absolute forefront of innovation in the field of drug safety monitoring,’ said Dr June Raine, MHRA Chief Executive. ‘Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing… This has the potential to transform our safety monitoring activities – enabling us to meet a real need by using high-quality patient data to reduce side effects of medicines.’

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Participant recruitment

Recruitment for the biobank will commence on 1 September and participants will be visited at home by a nurse who will take a blood sample to be added to the biobank. The sequencing of participants’ genetic material will begin in spring 2024. Initial research findings are due to be published in 2025.

The pilot phase will start by looking at allopurinol and related rare, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. Other topics of focus for the pilot phase will be confirmed in due course.

Genomics England will support the MHRA with the sequencing and storage of genetic material through use of its well-established and secure infrastructure.

Commenting on the ‘transformative partnership’ with the MHRA, Professor Matt Brown, Chief Scientific Officer for Genomics England, added: ‘Many [severe ADRs] are influenced by underlying genetic risk factors, substantially heightening an individual’s vulnerability.

‘By joining forces with the MHRA, we are poised to gain greater understanding of these genetic influences – discoveries that will be vital if we are to move to harness the power of genomics to proactively protect patients from these harms.

‘Together, we hope that this is the first step towards redefining the future of drug safety.’

ADRs continue to be a significant burden on the NHS and account for one in 16 hospital admissions.

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