FDA has approved the FoundationOne CDx (F1CDx) cancer biomarker assay concurrently with a decision from the Centers for Medicare & Medicaid Services (CMS) to provide insurance coverage for the next-generation sequencing (NGS)-based in vitro diagnostic (IVD) test.
FDA Approves Foundation Medicine’s FoundationOne CDx™, the First and Only Comprehensive Genomic Profiling Test for All Solid Tumors Incorporating Multiple Companion Diagnostics.
Read more about it here
US Too Prostate Cancer Panel Discussion and Webcast on Advanced Prostate Cancer
- Presented by: Bayer
- Sponsored by: Dendreon and Jannsen Oncology
- In Kind Sponsor: Los Padres
- Guest Speakers:
- Dr. Edwin Morales – Urology Specialist, San Antonio
- Dr. Michael Liss – Urologist, Urologic Oncologist, and Lead Prostate Cancer Researcher at UT Health, San Antonio
- Dr. Vijay K. Gunuganti – Medical Oncologist at Texas Oncology
- Moderator: Dr. Juan A. Reyna – Staff Physician at Audie L. Murphy Memorial VA Hospital; and Clinical Faculty at UT Health
Watch the recording here
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.
Read more on fda.gov
Genomic testing is done on cancerous tissue taken from the prostate in order to provide information about how your prostate cancer might behave. By looking at the genetic makeup of the cancer, these tests may help predict whether your prostate cancer grows slowly or aggressively.
Genomic testing can be performed on both biopsy tissue and on tissue from an entire prostate following a prostatectomy.
Read more on Zero