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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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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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The use of Crizotinib (Xalkori) has been expanded to treat advanced NSCLC in the patient group who carries a ROS-1 gene alteration

March 14, 2015 – The American Food and Drug Administration (FDA) just approved Crizotinib (Xalkori) to treat the patient subpopulation with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Crizotinib (Xalkori) is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC.

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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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Alectinib (Alecensa) approved for treatment of patients with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC)

December 12, 2015 – The American Food and Drug Administration today approved Alectinib (Alecensa) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Crizotinib (Xalkori).

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Theragenomic medicine: FDA approves Osimertinib (Tagrisso) to treat patients with non-small cell lung cancer (NSCLC) who carry the EGFR mutation T790M

November 14, 2015 – The American Food and Drug Administration (FDA) just granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Osimertinib (Tagrisso) was approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.

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Nivolumab (Opdivo) demonstrates survival benefit in squamous and non-squamous non-small cell lung cancer (NSCLC)

October 11, 2015 – In recent months, Nivolumab (Opdivo), a human IgG4 anti-PD-1 monoclonal antibody which targets the PD-1 receptor, had been approved first for the treatment of unresectable  or advanced (metastatic) melanoma and secondly for the treatment of advanced (metastatic) squamous non-small cell lung cancer (NSCLC).

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Remarkable: Pembrolizumab (Keytruda) now also for advanced non-small cell lung cancer (NSCLC)

October 06, 2015 –  Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. Among lung cancers, non-small cell lung cancer (NSCLC) is the most common type of lung cancer.

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FDA Approves Companion Genetic Diagnostic Test for Erlotinib [Tarceva] in NSCLC

May 14, 2013 – The US Food and Drug Administration (FDA) today announced the approval of the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Erlotinib (Tarceva). This is the first FDA-approved companion diagnostic that can detect epidermal growth factor receptor (EGFR) gene mutations,

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  • Development and analytical validation of a next-generation sequencing based microsatellite instabili October 18, 2019
    The referenced article describes an assay that has a clinically relevant five-day turnaround time and can be conducted on as little as 20 ng genomic DNA with a batch size of up to forty samples in a single run.
  • Lifestyle is a threat to gut bacteria: Ötzi proves it October 18, 2019
    The intestinal microbiome is a delicate ecosystem made up of billions and billions of microorganisms, bacteria in particular, that support our immune system, protect us from viruses and pathogens, and help us absorb nutrients and produce energy. The industrialization process in Western countries had a huge impact on its content. This was confirmed by a […]
  • Singapore completes whole genome sequencing analysis of multi-ethnic Asian populations October 18, 2019
    A new genetic databank has been established containing the completed whole-genome sequencing (WGS) data of close to 5,000 Singaporeans. Worldwide, WGS is increasingly used in research and healthcare to identify genetic variations using cutting-edge technologies that allow large numbers of individuals to be sequenced rapidly—This new study is the world's largest WGS analysis of Asian […]
  • Researchers quantify limitations of health reports from direct-to-consumer genetic tests October 17, 2019
    Health reports from direct-to-consumer (DTC) genetic tests that use a limited variant screening approach often yield clinical false-negative results, which pose the risk of informing health care decisions based on incomplete information, according to findings presented at the American Society of Human Genetics (ASHG) 2019 Annual Meeting in Houston, Texas.
  • Researchers develop mouse model of human gene involved in Alzheimer's disease October 17, 2019
    In research that helps scientists better understand and explore treatments for diseases like Alzheimer's, scientists have developed a line of mice in which the mouse version of the Alzheimer's-associated MAPT gene has been fully replaced by the human version of the gene. In this new animal model, known as a full gene-replacement model, the MAPT […]
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