Companion Diagnostic

As a pioneer in the molecular diagnostics industry with more than 20 years of experience discovering, developing, and delivering transformative molecular diagnostics to patients, Myriad will lead the industry into the exciting and important new field of companion diagnostics.

Currently Available Companion Diagnostic Products:


BRACAnalysis is a molecular diagnostic test developed by Myriad Genetics which analyzes the BRCA1 and BRCA2 genes to assess a woman’s risk for developing breast and ovarian cancer and guide treatment decisions for women with hereditary breast and ovarian cancer. A woman who tests positive with the BRACAnalysis test has, on average, up to an 87% risk of developing breast cancer during her lifetime and up to a 44% risk of developing ovarian cancer.

BRACAnalysis is also currently used by five pharmaceutical companies to identify patients who are more likely to respond therapeutics, such as Poly ADP ribose polymerase (PARP) inhibitors. Such therapeutics cause tumor-specific cell death by exploiting genomic repair deficiencies in the tumor.  BRACAnalysis can to identify those cancer patients more likely to have such tumors respond to these novel therapies.

CCP Assay

Myriad’s Cell Cycle Proliferation Assay (CCP) is in integral and proprietary element of Myriad’s Prolaris® product which, in conjunction with other clinical parameters, assesses the aggressiveness of prostate cancer. Myriad’s CCP measures the expression level of genes involved with cell cycle progression in tumor specimens to predict disease outcome.  The assay is performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory and is available to employ in prospective clinical trial to identify patients with more aggressive forms of a variety of cancers and therefore enrich for those patients who may benefit from experimental therapies.


Myriad’s PREZEONTM product assesses loss of PTEN function in cancer patients, which is associated with more aggressive disease progression and poorer survival. The PTEN gene is a major tumor suppressor that plays a critical role in cell signaling pathways that are the target of cancer drugs, such as PI3K, EGFR, MEK, AKT and mTOR inhibitors.

Myriad makes PREZEON available to Pharmaceutical partners for use in clinical trials and to support the development of commercial Companion Diagnostic products after approval.

Companion Diagnostic Products In Development:

HRD Assay

Genomic instability in tumor cells predicts response to a variety of currently available and experimental cancer therapies, including all platinum-based therapies and Poly ADP ribose polymerase (PARP) inhibitors. Myriad’s HRD Assay is performed on formalin-fixed, paraffin-embedded (FFPE) tumor samples and determines whether a cancer tissues genome is unstable. An indication of genomic instability predicts whether a patient is likely to respond to these specific classes of therapeutics.

A component of the HRD Assay includes tissue-based BRCA1 and 2 sequencing and the HRD Assay further expands clinical utility of Myriad’s commercially available test.

Myriad’s HRD Assay is being employed in variety of collaborations and offers great promise to increase to effectiveness of a wide range of cancer therapeutics.

Companion Diagnostic Partnerships:

Myriad has 20 year history of successful and productive partnerships and collaborations with the pharmaceutical industry. Looking forward, Myriad continues to seek strategic partnerships with the pharmaceutical industry as a means to best utilize current product offerings and develop new products.

Myriad offers pharmaceutical companies a unique complement of currently available Companion Diagnostics which may be readily utilized in a variety of clinical trial collaborations as well as a full suite of all cutting-edge discovery technologies and the most experienced molecular diagnostic discovery and development team.

Beyond discovery and development, Myriad brings unparalleled diagnostic commercialization resource with a sales, marketing and managed-markets team of close to 400 worldwide. The future of companion diagnostics will include a coordinated, fully-integrated sales effort.

For additional information and detail regarding collaboration opportunities with Myriad Genetics, please contact:



Patrick M. Burke, PhD
VP, Strategic Collaborations
Myriad Genetics, Inc.
Tel. +1 801 584-1195