Salt Lake City – Myriad Genetics, Inc. announced that AstraZeneca will use Myriad’s myChoice HRD Plus in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with Lynparza (olaparib) and Avastin (bevacizumab).
Under the agreement, Myriad will use its myChoice HRD Plus test to evaluate patients enrolled in an ongoing Phase III trial. In this collaboration, the companies will use the myChoice HRD Plus test to identify cases with homologous recombination deficiencies (HRD).
“As the pioneer in companion diagnostics for PARP inhibitors, we are excited to continue our collaboration with AstraZeneca and to apply innovative new technologies like myChoice HRD Plus to increase the number of patients who may benefit from Lynparza,” said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. “myChoice HRD Plus is the most comprehensive test for identifying defects in DNA repair pathways. We are optimistic that myChoice HRD Plus will identify more women with ovarian cancer who could benefit from therapy with Lynparza than previous tests that only identify germline BRCA1/2 mutations.”
The ongoing collaboration with AstraZeneca to develop a novel companion diagnostic test to identify candidates for treatment with olaparib began in 2007. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test approved by the FDA.
Ovarian cancer has the lowest survival rate of all female cancers. Ovarian cancer is diagnosed annually in nearly a quarter of a million women globally, and is responsible for 140,000 deaths each year. Statistics show that just 45 percent of women with ovarian cancer are likely to survive for five years. The majority of patients are only identified in the advanced stages when the disease becomes more difficult to treat.
Myriad’s myChoice HRD Plus is the most comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD Plus test is a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions) and up to 90 other genes and molecular markers including microsatellite instability associated with DNA repair pathways.
Positive myChoice HRD Plus scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian cancer and most other major cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.