Myriad Genetics has expanded its partnership to allow AstraZeneca and Merck to use its BRACAnalysis CDx companion diagnostic.

This in-vitro diagnostic device is designed to qualitatively detect and classify variants in protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes.

The diagnostic analyses genomic DNA obtained from blood samples.

Under the alliance, AstraZeneca and Merck will use the companion diagnostic to detect germline BRCA mutations in metastatic castrate-resistant prostate (mCRPC) cancer patients that are participating in the Phase III PROfound clinical trial.

“There is a significant unmet medical need in men with metastatic castration-resistant prostate cancer and BRCA1/2 mutations.”

PROfound will compare the safety and efficacy of AstraZeneca’s Lynparza (olaparib) to enzalutamide or abiraterone acetate in patients with homologous recombination repair gene mutations that had an inadequate response to previous therapy using a new hormonal agent.

Based on the results, Myriad intends to seek US Food and Drug Administration (FDA) approval for BRACAnalysis CDx as a companion diagnostic to Lynparza.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Myriad Oncology president Nicole Lambert said: “Our companion diagnostic collaboration with AstraZeneca and Merck has led to significant advancements in precision treatment for patients with ovarian breast cancer.

“However, there is a significant unmet medical need in men with metastatic castration-resistant prostate cancer and BRCA1/2 mutations, which is an area where the utility of PARP inhibitors is being explored. We look forward to this exciting opportunity to potentially expand the use of BRACAnalysis CDx in this setting.”

Myriad and AstraZeneca initially partnered on Lynparza in 2007. The collaboration led to approvals of BRACAnalysis CDx as a companion diagnostic in various breast cancer and ovarian cancer indications.