Myriad Genetics, Inc.
MYGN today announced that its Tumor BRACAnalysis CDx™ companion
diagnostic test significantly improved the detection of cancer-causing BRCA
1/2 mutations by 44 percent in women with ovarian cancer. Data from this new
study were presented at the 2014 European Society for Medical Oncology (ESMO)
annual meeting in Madrid, Spain.
"Several previous clinical studies have demonstrated that patients with
germline or somatic BRCA 1/2 mutations respond to certain DNA-damaging
medicines such as the platinum drugs," said Colin Hayward, M.D., European
medical director at Myriad Genetics. "Tumor BRACAnalysis CDx also has the
potential to greatly expand the number of ovarian cancer patients who may
respond to treatment with PARP inhibitors."
This study evaluated 131 previously untreated patients with high-grade ovarian
cancer.Blood samples were tested for germline (hereditary) BRCA
mutations.Additionally, tumor samples were obtained from patients receiving
surgery and were tested for both somatic (tumor) and germline BRCA mutations.
The data analysis included 92 patients who completed testing for both germline
and somatic mutations.The results show that the Tumor BRACAnalysis CDx test
identified 28.3 percent of women with either germline or somatic BRCA 1/2
mutations.In contrast, blood germline testing only identified the 19.6 percent
of patients with germline BRCA 1/2 mutations.The somatic mutations identified
by Tumor BRACAnalysis CDx testing represent a 44 percent increase in the
detection of cancer-causing BRCA mutations over germline testing.
Ovarian Cancer Patients with BRCA 1/2 Mutations
Tumor BRACAnalysis Blood Germline
CDx™ Testing (N=92) BRCA Testing (N=92)
BRCA 1 Mutations 12 germline 12 germline
5 somatic 0 somatic
BRCA 2 Mutations 6 germline 6 germline
3 somatic 0 somatic
% of mutations by 19.6% (germline) 19.6% (germline)
type 8.7% (somatic) –
Total % of Patients 28.3% 19.6%
"In this study, tumor analysis identified substantially more patients with
BRCA 1/2 mutations than germline blood testing alone," said Melinda Yates,
Ph.D., of the MD Anderson Cancer Center in Houston, Texas and a study
investigator. "The logical path forward is to use tumor testing to identify
the greatest number of patients with BRCA 1/2 mutations."
It is estimated that 65,000 women in Europe are diagnosed with ovarian cancer
annually. Ovarian cancer tends to have high mortality rates and most patients
face disease recurrence with limited treatment options, and Myriad is
committed to working with pharmaceutical company partners to bring promising
new therapies to market to improve the treatment of this lethal disease.
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