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

The emergence of #therapeutic #radiopharmaceuticals and its adoption in #cancer care provide one more weapon in combating cancer

Getty Images

Feature | Radiation Oncology | May 04, 2021 | By Vinay Shivaprasad
The term nuclear medicine is associated with the diag
A 37-year-old woman developed a new, palpable left supraclavicular lymphadenopathy lump five days after her first dose of the Moderna COVID-19 vaccine in the left arm. On the day of vaccination, the patient was asymptomatic. This is an example of how the vaccine can mimic cancer and swollen lymph nodes. Image used with permission of RSNA.

A 37-year-old woman developed a new, palpable left supraclavicular lymphadenopathy lump five days after her first dose of the Moderna COVID-19 vaccine in the left arm. On the day of vaccination, the patient was asymptomatic. This is an example of how the vaccine can mimic cancer and swollen lymph nodes. Read more about this case study. Image used with permission of RSNA.

Feature | Coronavirus (COVID-19) | May 03, 2021 | By Dave Fornell, Editor
While the mass COVID-19 vaccinat
A 63-year-old multiple #myeloma patient, with skeletal pain. New #FDG avid axillary #lymphadenopathy 62 days (9 weeks) after second #mRNA #vaccination dose. Image used with permission of the Radiological Society of North America (#RSNA)

A 63-year-old multiple myeloma patient, with skeletal pain. New FDG avid axillary lymphadenopathy 62 days (9 weeks) after second mRNA vaccination dose. Image used with permission of the Radiological Society of North America (RSNA)

Feature | Coronavirus (COVID-19) | April 29, 2021 | By Melinda Taschetta-Millane
ACR releases 13 new topics and five revised topics to support referring physicians and other providers in making the most appropriate imaging or treatment decisions
News | Radiology Imaging | April 26, 2021
April 26, 2021 — The American College of Radiology (ACR) released an update to its...
The Imagio Breast Imaging System combines laser light and sound with conventional ultrasound technology to provide fused functional and anatomic images (referred to as optoacoustic/ultrasound or OA/US) in real time, increasing confidence in diagnostic accuracy.

The Imagio Breast Imaging System combines laser light and sound with conventional ultrasound technology to provide fused functional and anatomic images (referred to as optoacoustic/ultrasound or OA/US) in real time, increasing confidence in diagnostic accuracy.

News | Breast Imaging | April 23, 2021
April 23, 2021 — The U.S.
A Norwegian study for the first time reveals benefit of the #PARP inhibitor #Olaparib in patients with early #breastcancer not harboring germline mutations

Getty Images

News | Radiation Therapy | April 22, 2021
April 22, 2021 — Targeted therapy in early stages of breas...