“Researchers from Genentech, Foundation Medicine, UC Davis, and other medical centers, have published a report on the development and early validation of Foundation’s planned blood-based tumor mutational burden test.
“Appearing today in Nature Medicine, the study describes the development of the test and its characteristics, and its retrospective validation in two cohorts. Investigators demonstrated, by applying the assay to samples from two clinical trials, that blood-based TMB (bTMB) could reproducibly identify lung cancer patients who respond to immunotherapy treatment with Roche/Genentech’s atezolizumab (Tecentriq).”
“The use of genetic tests aimed at detecting the presence of mutations in the BRCA1 and BRCA2 genes in women with breast cancer is rapidly declining in favor of tests that can detect multiple cancer-associated mutations, according to researchers at the Stanford University School of Medicine and five other U.S. medical centers.
“Some researchers had wondered whether multigene testing, which may identify genetic mutations of uncertain clinical significance, would lead more women to consider prophylactic mastectomies — a surgery in which both breasts are removed to prevent future cancers — out of an abundance of caution. However, the current study did not show an increase in mastectomies associated with testing more genes.”
“According to findings published in Nature Communications, a blood test detecting early changes in circulating tumor DNA (ctDNA) may provide earlier indication of whether patients with hormone receptor–positive, HER2-negative breast cancer are responding to the CDK4/6 inhibitor palbociclib (Ibrance).
“The test could detect a response within 2 to 3 seeks, said investigators with The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust. Women currently wait 2 to 3 months to find out if palbociclib treatment is working for them.”
“The FDA authorized marketing the direct-to-consumer Personal Genome Service Genetic Health Risk Report for three mutations of BRCA1 and BRCA2 most common among people of Eastern European Ashkenazi Jewish descent, according to a press release.
“The test — marketed by 23andMe — analyzes DNA using self-collected saliva samples to determine whether a woman is at increased risk for breast and ovarian cancer and whether a man is at increased risk for breast or prostate cancer.”
“GenomeDx Biosciences, a leader in the field of urologic cancer genomics, today announced that its Decipher® Prostate Biopsy and Decipher Prostate RP molecular assays for prostate cancer are now included in the 2018 National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology [Version 1.2018].
“The NCCN Guidelines are the recognized clinical standard for cancer care, and are developed and revised by a panel of expert physicians from 27 leading U.S. cancer centers. The panel revises recommended practice guidelines according to current evidence and advances in cancer care.”
“Myriad Genetics, Inc. (MYGN) today announced that a comparative analysis of commercially available prognostic breast cancer tests in patients with early-stage breast cancer has been published in JAMA Oncology. A key finding is that Myriad’s EndoPredict® (EPClin) significantly outperformed Oncotype DX® Recurrence Score at predicting the risk of disease recurrence in patients with early-stage breast cancer.
“In the article, Sestak et al. compared the prognostic value that four different commercial tests add to the Clinical Treatment Score (nodal status, tumor size, grate, age, endocrine treatment) for predicting distant recurrence (0-10 years) and late-distant recurrence (5-10 years) of breast cancer. The analysis included data from 774 postmenopausal women with ER+/HER2- breast cancer with node-negative disease or up to three positive lymph nodes, which is the most common form of breast cancer.”
Diagnosis of adenocarcinoma of the lung, a major subtype of non-small lung cancer (NSCLC), nowadays triggers mandatory testing of tumor tissue for alterations in four genes: EGFR, ALK, ROS1, and more recently, BRAF. If present, these alterations predict sensitivity to specific targeted drugs approved by the U.S. Food and Drug Administration (FDA) that work better and often longer than standard chemotherapy, and are better tolerated.
However, there are many more targetable/actionable genomic alterations (also known as “drivers”) in NSCLC. This blog post will briefly discuss most of them, with the goal of promoting molecular testing for more than the four “usual suspects” mentioned above. Some patients with these alterations may benefit from FDA-approved drugs or from enrollment in clinical trials that are testing additional drugs and drug combinations. Continue reading…
“People diagnosed with cancer understandably reach for the very best that medical science has to offer. That motivation is increasingly driving people to ask to have the DNA of their tumors sequenced. And while that’s useful for some malignancies, the hype of precision medicine for cancer is getting far ahead of the facts.
“It’s easy to understand why that’s the case. When you hear stories about the use of DNA sequencing to create individualized cancer treatment, chances are they are uplifting stories. Like that of Ben Stern.”
“U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws.
“The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.
“The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now and will lead more insurers to cover it.”