December 28, 2020 – Some 95% of people have gene variants that may negatively affect their response to at least one drug, leading to unexpected or adverse drug reactions (ADRs) or, if unlucky, to a serious, if not fatal, adverse …

Genetics behind some serious adverse drug reactions (SADRs) Read more »

September 18, 2019 – This post is an edited version of parts of a paper that appeared in the Journal of Personalised Medicine (JPM) a week ago und which addresses one of the important topics in connection with the themes of …

Clinical evidence and implementation challenges for pharmacogenomic testing Read more »

April 07, 2019 – Consumers are increasingly embracing genetic testing to better understand their individual risk for developing diseases. With this rise in popularity and availability, we’re also seeing significant activity in the field of pharmacogenetics, which is the process …

Genomics lab illegally markets genetic tests that claim to predict patient responses to drugs Read more »

January 26, 2019 – Pharmacogenomic approaches are increasingly revealing newly identified genes and genetic variants that are at the base of remarkable inter-individual pharmacokinetic and pharmacodynamic variation of novel direct oral anticoagulants (DOAC). Lately, DOACs have shown an upward prescribing trend due …

Direct Oral Anticoagulants (DOAC): Newly Identified Genes and Genetic Variants Read more »

November 08, 2018 –  The American Food and Drug Administration (FDA) has just authorized the first direct-to-consumer test for detecting genetic variants in genes that may govern the metabolism of drugs in individual patients. Thus, FDA permits marketing, with special controls, the …

Living theragenomic medicine: Direct to consumer test for metabolism of drugs FDA approved Read more »

June 16, 2017 – Patient education in pharmacogenetics, the central component of theragenomic and personalized medicine and individualized drug safety is an important issue. Not only needs the individual patient to understand what pharmacogenetics, or more precisely, pharmacogenetic testing can …

Development of a patient education video about pharmacogenetics Read more »

September 19, 2016 – This post presents below a virtually unedited announcement by the American Food & Drug Administration (FDA) concerning Duchenne Muscular Dystrophy (DMD) therapy  option which gives much hope for at least some of the affected patients. However, be …

Eteplirsen (Exondys 51) for Duchenne Muscular Dystrophy (DMD) approved Read more »

Sacco K, Grech G EPMA J 2015;6(1):15 PMID: 26203310 Abstract Breast cancer is a heterogeneous disease that necessitates proper patient classification to direct surgery, pharmacotherapy, and radiotherapy. Despite patients within the same subgroup receiving similar pharmacotherapy, substantial variation in clinical …

Actionable pharmacogenetic markers for prediction and prognosis in breast cancer Read more »

July 9, 2016 – This is a huge step into the future of theragenomic and personalized medicine and individualized drug safety. In support of the President’s Precision Medicine Initiative (PMI), the American Food & Drug Administration (FDA) just issued two …

Precision Medicine Initiative: draft guidances issued Read more »

February 07, 2016 – The European Commission has approved once-daily Osimertinib (Tagrissa) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) that is positive for the epidermal growth-factor receptor (EGFR) T790M mutation. This follows a positive review in …

Osimertinib (Tagrissa) approved for non-smal cell lung cancer (NSCLC) patient subgroup carrying the EGFR T790M mutation Read more »