The Medicines and Healthcare products Regulatory (MHRA) and Genomics England to launch a brand-new genetic research resource, known as a ‘biobank’ on Thursday (June 01) to tackle the issue of Adverse Drug Reactions (ADRs).
Biobank will help 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,” said MHRA.
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: “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.
Steve Barclay, Health and Social Care Secretary, said: “Adverse drug reactions place a huge strain on the NHS, costing the health service over £2 billion a year – so it’s vital that we tackle this issue to help us cut waiting lists and get patients the tailored care they need.
Developing a better understanding of our DNA can transform outcomes for patients, through improved treatments and sped-up diagnosis for conditions such as cancer and rare diseases.
We’re backing research programmes with £175 million, like this biobank, which will harness the UK’s genomic capabilities to help patients receive safe, effective medicines.”