Blog Archives

Ivosidenib (Tibsovo) for AML-patients with IDH1-mutations

July 22, 2018 – The American Food and Drug Administration (FDA) just approved Ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation in the IDH1 gene.  

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Olaparib Tablets (Lynparza): For breast cancer with BRCA gene mutation

January 13, 2018 – The American Food and Drug Administration (FDA) has just approved the first treatment for breast cancer with a certain inherited genetic mutation. At first glance, this announcement may be just one in the series of announcements by the FDA on new drug approvals.

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FDA-cleared genomic profiling tests to guide cancer treatment

December 25, 2017 – The American Food & Drug Administration (FDA) has approved two genetic tests to identify genetic alterations in tumors.  The FoundationOne CDx (F1CDx) genomic test and the MSK-IMPACT Tumor Profiling test both can help to guide physicians in clinical trial enrollment and in cancer treatment.

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Enasidenib (Idhifa): Targeted treatment for relapsed or refractory AML

August 02, 2017 – This is another cornerstone in the fight against acute myeloid leukemia (AML): The American Food and Drug Administration (FDA) just approved Enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.

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The Clinical and Economic Impact of Inaccurate EGFR Mutation Tests in the Treatment of Metastatic Non-Small Cell Lung Cancer

June 30, 2017 – The below citation from PubMed addresses an vey important issue associated with genetic testing in theragenomic and personalized medicine. It is the question if the genetic test used to stage, classify, or determine treatability of a disease with a given drug is accurate.

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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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Genetic outfit at work: Rucaparib (Rubraca) for ovarian cancer with deleterious BRCA mutation(s)

February 01, 2017 – This is an announcement by the American Food & Drug Administration (FDA) who announced on December 19, 2016, that it granted accelerated approval to Rucaparib (Rubraca) to treat women with a certain type of ovarian cancer. Rucaparib (Rubraca) was approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.

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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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This is it: First blood test to detect EGFR gene mutations in NSCLC

June 03, 2016 – This is a huge step in the application of theragenomic medicine in cancer patients in the quest to deliver highly individualized health care for patients. Thus, on June 01, the American Food & Drug Administration (FDA) approved the cobas EGFR Mutation Test v2,

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  • Descendants of early Europeans and Africans in US carry Native American genetic legacy September 19, 2019
    Many people in the U.S. do not belong to Native American communities but still carry bits of Native American DNA, inherited from European and African ancestors who had children with indigenous individuals during colonization and settlement. In a new study published 19th September in PLOS Genetics, Andrew Conley of the Georgia Institute of Technology and […]
  • IGF1 gene is essential to adult tendon growth, animal study shows September 19, 2019
    Tendon injuries are among the most common injuries seen in athletes at all levels, from weekend warriors to professional basketball players. For those who rupture their tendons, returning to the same level of physical activity they enjoyed before the injury is rare.
  • Researchers create new protocol to improve gene therapy tool production September 19, 2019
    A method to create a faster and lower cost alternative for a gene therapy tool has been developed by Boston University School of Medicine (BUSM) researchers.
  • Genetic variants with possible positive implications for lifestyle September 19, 2019
    A German and British research team lead by Technical University of Munich (TUM) has examined the interplay between genetics, cardiovascular disease and educational attainment in a major population study. Genetic variants which had been linked to educational attainment in other studies were observed in the subjects. The researchers found that these variants also had implications […]
  • Scientists develop new methodology to genetically modify lab mice and human cells September 19, 2019
    A team led by Cedars-Sinai has designed a rapid method to genetically alter laboratory mice and then used this method to produce personalized animal models of pediatric glioma, an aggressive type of malignant brain cancer in children.
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