MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines

A brand-new genetic research resource, known as a ‘biobank’, will be piloted by the Medicines and Healthcare products Regulatory Agency (MHRA) in a joint venture with Genomics England to better understand how a patient’s genetic makeup can impact the safety of their medicines.

The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices. It forms part of a long-term vision for more personalised medicine approaches, as scientists will use the repository of genetic information in the biobank to determine whether a side effect from a medicine was caused by a specific genetic trait. This will in turn enable doctors to target prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup.

Adverse Drug Reactions (ADRs), or side effects, continue to be a significant burden on the NHS and account for one in 16 hospital admissions. Understanding the underlying mechanism of an adverse reaction would support the development of pharmacogenetic testing strategies, such as the screening tests enabled through the information provided by the Yellow Card biobank. These strategies would in turn provide the opportunity to prevent rather than react to adverse drug reactions.

The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. The sequencing of participants’ genetic material will begin in Spring 2024, with initial research findings from the pilot due to be published in 2025. Genomics England will be supporting the MHRA with sequencing and storage of genetic material through use of their well-established and secure infrastructure.

The pilot phase will start with a medicine called allopurinol and related rare, severe skin reactions; including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Other topics of focus for the pilot phase will be confirmed in due course.

Patients who get involved will be visited at home by a nurse, who will then take a blood sample to be added to the biobank and sequenced. Participants’ data will be de-identified and added to a secure research environment led and managed by Genomics England.

Dr June Raine DBE, MHRA Chief Executive, said: “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.

“Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing.

“The biobank will help us move towards our goal of personalised medicine – which, when achieved, means patients across the UK will receive the safest medicine for them, based on their genetic makeup.

“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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