Myriad Genetics Inc, Salt Lake City, has announced that results from the Phase III Polo study have shown that the company’s BRACAnalysis CDx test can identify patients with metastatic pancreatic cancer who have BRCA mutations and can benefit from treatment with olaparib, a novel poly (ADP-ribose) polymerase (PARP) inhibitor. Myriad plans to file a supplementary premarket approval application with FDA, to obtain market authorization for the use of BRCAnalysis CDx as a companion diagnostic for olaparib, with an exclusive commercialization agreement.

Johnathan Lancaster, MD, PhD, Myriad Genetic Laboratories.

Johnathan Lancaster, MD, PhD, Myriad Genetic Laboratories.

“The results of the Polo trial strongly support use of the BRACAnalysis CDx test to help inform treatment decisions in the metastatic pancreatic cancer setting and will expand the patient population who can benefit from BRCA testing,” says Johnathan Lancaster, MD, PhD, chief medical officer at Myriad Genetics. “This study underscores Myriad’s commitment to our pharmaceutical partners and to advancing the field of personalized medicine for patients with cancer.”

BRACAnalysis CDx is an in vitro diagnostic intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes. The test uses samples of genomic DNA obtained from whole blood specimens collected in ethylenediaminetetraacetic acid (EDTA). Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.

The topline results announced by AstraZeneca, Cambridge, UK, and MSD Inc, Kenilworth, NJ (known as Merck & Co Inc inside the United States and Canada), are the first reported clinical data from the Polo study, which assessed the efficacy of olaparib as first-line maintenance monotherapy in patients with germline BRCA-mutated, metastatic pancreatic cancer whose disease had not progressed on platinum-based chemotherapy.1 The results demonstrated a statistically significant and clinically meaningful improvement of progression-free survival (PFS) among BRCA-mutated patients treated with olaparib compared to placebo.

“We congratulate AstraZeneca and Merck on these exciting study results and are excited to expand the use of BRACAnalysis CDx in this patient population,” says Nicole Lambert, general manager, Myriad Oncology. “Data from multiple clinical studies have consistently shown that BRACAnalysis CDx can accurately identify patients for treatment with multiple PARP inhibitors.”

BRACAnalysis CDx is the only FDA-approved germline BRCA1/2 test. It is estimated there were 466,000 new cases of pancreatic cancer diagnosed globally in 2018. Germline BRCA-mutated pancreatic cancer accounts for 5% to 7% of all cases. Pancreatic cancer is the fourth leading cause of cancer death, and less than 7% of patients survive more than 5 years after diagnosis. Approximately 80% of patients are diagnosed at the metastatic stage.

Olaparib is being commercialized by AstraZeneca and MSD Inc. The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.

For further information, visit Myriad Genetics.


  1. Lynparza significantly delayed disease progression as first-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer [online]. Cambridge, UK: AstraZeneca, 2019. Available at: . Accessed March 6, 2019.