Blog Archives

Breast Cancer: Performance of prognostic signatures

February 17, 2018 – In a new study, published in JAMA Oncology online on February 15, 2018, a comparison of the performance of 6 prognostic signatures for estrogen receptor (ER) –positive breast cancer was performed in a secondary analysis of a randomized clinical trial.

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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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FDA recommends against use of ovarian cancer screening tests

September 08, 2016 – Ovarian cancer occurs when abnormal cells in or near the ovaries grow and form a malignant (cancerous) tumor. In the United States, ovarian cancer is the fifth leading cause of cancer-related death among women. The National Cancer Institute estimates that in 2016,

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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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Bloom Syndrome: FDA permits marketing of first direct-to-consumer genetic carrier test

February 22, 2015 – The U.S. Food and Drug Administration authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in the BLM gene that could lead to their offspring inheriting the serious disorder.

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FDA approves first non-invasive DNA screening test for colorectal cancer

August 11. 2014 – The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.

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  • Genetically engineered animals offer fresh hope to heart valve patients December 6, 2019
    Scientists have cloned a genetically engineered bull which they hope will help heart valve transplant patients lead better quality lives and benefit people with red meat allergies.
  • 'Junk DNA' affects inherited cancer risk December 6, 2019
    A person's risk of developing cancer is affected by genetic variations in regions of DNA that don't code for proteins, previously dismissed as 'junk DNA', according to new research published in the British Journal of Cancer today.
  • Gene network sparks future autism treatment December 5, 2019
    A mutated gene found in people with intellectual disabilities that could be targeted for treatment has been identified by an international team including University of Queensland researchers.
  • Tick, tock: How stress speeds up your chromosomes' aging clock December 5, 2019
    Ageing is an inevitability for all living organisms, and although we still don't know exactly why our bodies gradually grow ever more decrepit, we are starting to grasp how it happens.
  • Genome testing for siblings of kids with autism may detect ASD before symptoms appear December 5, 2019
    One of the key priorities of interventions for autism spectrum disorder (ASD) is starting early, with some evidence showing infants as young as seven months old could benefit. Yet, most children in North America aren't diagnosed with ASD until they're over four years of age. New research led by The Hospital for Sick Children (SickKids) […]
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