News | Oncology Diagnostics | April 05, 2018

Myriad Receives Pre-Market Approval for BRACAnalysis Diagnostic System in Japan

Indicated as a companion diagnostic for Lynparza (olaparib) for use in patients with metastatic inoperable or recurrent breast cancer

April 5, 2018 — Myriad Genetic Laboratories Inc. announced that the Japanese Ministry of Health, Labour and Welfare has granted manufacturing and marketing approval for Myriad’s BRACAnalysis Diagnostic System to be used as a companion diagnostic with the PARP inhibitor, Lynparza.  Lynparza is marketed by AstraZeneca and Merck, known as MSD outside the United States and Canada.

AstraZeneca and Merck are seeking approval of Lynparza in Japan for treating patients with BRCA-mutated metastatic breast cancer. BRACAnalysis is the first and only diagnostic test for a PARP inhibitor to receive regulatory approval in Japan. The test is marketed in the United States as BRCAnalysis CDx.

Currently there are about 40,000 patients with metastatic disease that would be eligible for BRACAnalysis testing in Japan, with an estimated 15,000 new cases of HER2-negative breast cancer diagnosed each year. Myriad will commercialize BRACAnalysis in exclusive partnership with the SRL Inc., a subsidiary of Miraca Group, and one of the largest laboratory service providers in Japan.

BRACAnalysis is a diagnostic system that classifies a patient’s clinically significant variants (DNA sequence variations) in the BRCA1 and BRCA2 genes. Variants are classified into one of the five categories — “Deleterious,” “Suspected Deleterious,” “Variant of Uncertain Significance,” “Favor Polymorphism” or “Polymorphism.” Once the classification is completed, the results are sent to medical personnel in Japan for determining the eligibility of patients for treatment with Lynparza.

BRACAnalysis CDx was approved by the U.S. Food and Drug Administration (FDA) in December 2014 for patients with advanced ovarian cancer, and again in January 2018 for patients with HER2-negative metastatic breast cancer.

For more information: www.myriad.com

 

Related Content

IBM collected a dataset of 52,936 images from 13,234 women who underwent at least one mammogram between 2013 and 2017.

IBM collected a dataset of 52,936 images from 13,234 women who underwent at least one mammogram between 2013 and 2017, and who had health records for at least one year prior to the mammogram. The algorithm was trained on 9,611 mammograms. Image courtesy of Radiology.

Feature | Artificial Intelligence | July 19, 2019 | Michal Chorev
Breast cancer is the global leading cause of cancer-related deaths in women, and the most commonly diagnosed cancer...
Paragon Biosciences Launches Qlarity Imaging to Advance FDA-cleared AI Breast Cancer Diagnosis System

Qlarity Imaging’s software is used to assist radiologists in the assessment and characterization of breast lesions. Imaging features are synthesized by an artificial intelligence algorithm into a single value, the QI score, which is analyzed relative to a database of reference abnormalities with known ground truth. Image courtesy of Business Wire.

Technology | Artificial Intelligence | July 18, 2019
Paragon Biosciences LLC announced the launch of its seventh portfolio company, Qlarity Imaging LLC, which was founded...
New Lung Ambition Alliance Aims to Double Five-year Lung Cancer Survival by 2025
News | Lung Cancer | July 17, 2019
The International Association for the Study of Lung Cancer (IASLC), Guardant Health, the Global Lung Cancer Coalition (...
FDA Clears Koios DS Breast 2.0 AI-based Software
News | Ultrasound Women's Health | July 11, 2019
Koios Medical announced its second 510(k) clearance from the U.S. Food and Drug Administration (FDA).
SimonMed Imaging Implements ProFound AI for 3-D Tomosynthesis
News | Mammography | July 10, 2019
Arizona-based SimonMed Imaging announced their implementation of the first U.S. Food and Drug Administration (FDA)-...
Therapixel Appoints Matthieu Leclerc-Chalvet as CEO
News | Artificial Intelligence | July 03, 2019
Artificial intelligence (AI) breast cancer screening specialist Therapixel announced the appointment of Matthieu...
GE Healthcare showcases Senographe Pristina Serena featuring its add-on-biopsy kit at the Breast Imaging Symposium. Photo by Greg Freiherr

GE Healthcare showcases Senographe Pristina Serena featuring its add-on-biopsy kit at the Breast Imaging Symposium. Photo by Greg Freiherr

Feature | Breast Imaging | July 03, 2019 | By Greg Freiherr
Productivity and its enabler — efficiency — guided the display of products at the April...
Countless possibilities can impact the future of global healthcare and AI is the first step toward breakthrough that will change the landscape of personalized medicine
Feature | Women's Health | July 03, 2019 | By Samir Parikh
Contrary to what many people believe,...

Image courtesy of GE Healthcare

Feature | Radiology Business | July 03, 2019 | By Jeffrey Hoffmeister, M.D.
Burnout in the medical profession is not uncommon, particularly as clinicians have become more overwhelmed by growing
iCAD ProFound AI

Image courtesy of iCAD

News | Breast Imaging | June 25, 2019
Use of...