Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

HLA-B*5701 allele and abacavir

• Abacavir is used to treat HIV infection, and should not be used in patients known to carry the HLA-B*5701 allele. • The PREDICT-1 study* demonstrated that patients who carry the HLA-B*5701 allele have around a 50-60% risk of developing a hypersensitivity reaction to the drug, which can be life-threatening • Screening for the allele is mandatory prior to commencing treatment → Mandatory biomarker test → No drug without CDx • In non-carriers the risk is <4%

*N Engl J Med 2008;358:568-79

The Organisation for Professionals in Regulatory Affairs

9

CDx and the IVDR

• A corresponding CDx is now essential for >20% of new drugs • The examples of gefitinib and abacavir illustrate the importance of a correct CDX test result • CDx is defined for the first time in IVD legislation • In the second half: • The key regulatory requirements are summarised • Implications for device and drug developers are considered

The Organisation for Professionals in Regulatory Affairs

10

5