Press release

Myriad Obtains CE Mark for Tumor BRACAnalysis CDx(TM) and Launches Test in Europe as Companion Diagnostic for PARP Inhibitors - See more at:
Myriad Genetics
Myriad Genetics, Inc. today announced the Company has obtained CE Marking in Europe for its Tumor BRACAnalysis CDx test, which identifies tumors that have mutations in the BRCA1 or BRCA2 genes.
Myriad Genetics, Inc. today announced the Company has obtained CE Marking in Europe for its Tumor BRACAnalysis CDx test, which identifies tumors that have mutations in the BRCA1 or BRCA2 genes. Tumor BRACAnalysis CDx is the first and only tumor-based companion diagnostic that is CE-marked and can identify patients that would be appropriate for Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor.

"Obtaining a CE Marking for Tumor BRACAnalysis CDx is a significant milestone and achievement for the Myriad team. The CE Mark allows us to offer a validated tumor-based test for use as a companion diagnostic with Lynparza and future PARP inhibitors in Europe," said Gary King, executive vice president, International Operations, Myriad. "We are actively engaged in strategic activities with thought leaders and cancer centers to ensure a successful launch in Europe."

Last month, the European Medicines Agency's (EMA) approved Lynparza as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. It is estimated that more than 28 percent of ovarian cancer patients carry a deleterious germline or somatic mutation in the BRCA1 or BRCA2 genes and may benefit from Lynparza therapy. In clinical studies conducted by Myriad, the Tumor BRACAnalysis CDx test identified up to 44 percent more cancer patients with BRCA mutations who are candidates for treatment with PARP inhibitors, compared to conventional germline BRCA testing alone.

"The trend in modern medicine is toward tailored therapy that will give patients the best chance for successful outcomes. In ovarian cancer, it is critical to identify which patients have somatic or germline BRCA mutations and may benefit from the new class of PARP inhibitors," said Colin Hayward, M.D., European medical director, Myriad. "Tumor BRACAnalysis CDx is the most effective method for screening patients since it detects both germline and somatic BRCA mutations. It provides physicians with confidence that they will identify the greatest number of patients who are candidates for this new breakthrough class of drugs."

Myriad Genetics GmbH offers Tumor BRACAnalysis CDx throughout Europe performed at its laboratories in Munich, Germany. The test has an average 14-day laboratory turnaround time, which is essential for timely treatment decision-making by physicians and patients For more information, please call Myriad Genetics GmbH at: +41 44 939 91 44 or visit:

About Tumor BRACAnalysis CDx™

Myriad's Tumor BRACAnalysis CDx is the most robust and accurate companion diagnostic test for identifying both germline (hereditary) and somatic (tumor) cancer-causing mutations in the BRCA1 and BRCA2 genes. Tumor BRACAnalysis CDx has undergone significant analytic validation and has been shown to identify up to 44 percent more patients with cancer-causing BRCA1/BRCA2 mutations compared to germline testing alone. Myriad is actively collaborating with leading pharmaceutical companies to develop Tumor BRACAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other novel chemotherapeutic agents.

About Myriad Genetics GmbH

Myriad Genetics GmbH is based in Zurich, Switzerland and is the international subsidiary of Myriad Genetics Inc., a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. For more information on how Myriad Genetics GmbH is making a difference, please visit the Company's European website:
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