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

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 of understanding what, if any, role genetics plays in a patient’s reaction to particular drugs,

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

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).

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

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,

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Development of a patient education video about pharmacogenetics

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 do for him in the process of

selection of the “right”

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Eteplirsen (Exondys 51) for Duchenne Muscular Dystrophy (DMD) approved

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.

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Actionable pharmacogenetic markers for prediction and prognosis in breast cancer

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 outcomes is observed.

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Precision Medicine Initiative: draft guidances issued

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 draft guidances that,

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

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 December 2015.

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Genetic Variants Predict Lithium Response in Bipolar Disorder

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Is there help for patients suffering from gout? Lesinurad (Zurampic) approved for the treatment of high blood uric acid levels

December 24, 2015 – The American Food and Drug Administration (FDA) just approved Lesinurad  (Zurampic) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI),

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