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 …

Breast Cancer: Performance of prognostic signatures Read more »

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 …

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

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 …

FDA-cleared genomic profiling tests to guide cancer treatment Read more »

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 …

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

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 …

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

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 …

FDA recommends against use of ovarian cancer screening tests 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 »

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 …

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

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 …

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

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 …

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