FDA Approves Genetic Test for HER2+ Breast Cancer

The US Food and Drug Administration (FDA) has approved Inform Dual ISH (Ventana Medical Systems), a genetic test that allows for measurement of the number of copies of the HER2 gene in tumor tissue. This method of identification of women with breast cancer who are HER2-positive pinpoints who is, and who is not, a candidate for Herceptin (trastuzumab).

 

With this test lab staff can stain the sample with chemicals that cause copies of HER2 genes and chromosome 17 to change color, thus allowing them to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time.

 

Approval was based on a US study of tumor samples from 510 patients with breast cancer, which showed the test correctly confirmed 96% of HER2-positive tissues.

 

Read the FDA announcement:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259055.htm

Related Items
Gavreto, RET Inhibitor, FDA Approved for Metastatic NSCLC with RET Fusions
Web Exclusives published on November 16, 2020 in FDA Updates
FDA NEWS: November 2020
TOP - November 2020 Vol 13, No 6 published on November 9, 2020 in FDA Updates
FDA News: September 2020
TOP - September 2020 Vol 13, No 5 published on September 14, 2020 in FDA Updates
FDA News: July 2020
TOP - July 2020, Vol 13, No 4 published on July 15, 2020 in FDA Updates
Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
Web Exclusives published on June 22, 2020 in FDA Updates, Lung Cancer
Opdivo Approved for Advanced Esophageal Squamous-Cell Carcinoma
Web Exclusives published on June 22, 2020 in FDA Updates
FDA Approves Cyramza plus Tarceva for First-Line Treatment of Metastatic NSCLC with EGFR Mutation
Web Exclusives published on June 8, 2020 in FDA Updates, Lung Cancer
Opdivo plus Yervoy and Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
Web Exclusives published on June 2, 2020 in FDA Updates, Lung Cancer
Tecentriq plus Avastin First Immunotherapy Regimen Approved for Metastatic Hepatocellular Carcinoma
Web Exclusives published on June 2, 2020 in FDA Updates, Hepatocellular Carcinoma
Lynparza First Targeted Therapy Approved for Metastatic Prostate Cancer with HRR Mutation
Web Exclusives published on May 26, 2020 in FDA Updates, Prostate Cancer
Last modified: April 27, 2020