The statement supports tissue based molecular testing for prostate cancer risk stratification in low and favorable-intermediate risk men and germline
testing for hereditary cancer syndrome in prostate cancer patients with a family history of cancer or high-risk disease.
Cancer information company ACT Genomics said on Thursday that it has agreed for both somatic and germline
genetic testing of BRCA in patients with ovarian cancer with the advanced next generation sequencing (NGS) technology in Singapore and Taiwan in collaboration with AstraZeneca Singapore.
Lynparza was first approved by the FDA in 2014 to treat certain patients with ovarian cancer and is now indicated for the treatment of patients with germline
breast cancer susceptibility gene (BRCA) mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been previously treated with chemotherapy.
Loss of nuclear expression of MLH1 and PMS2: testing for methylation of the MLH1 promoter is indicated (the presence of MLH1 methylation suggests that the tumor is sporadic and germline
evaluation is probably not indicated; absence of MLH1 methylation suggests the possibility of Lynch syndrome, and sequencing and/or large deletion/duplication testing of germline
MLH1 is indicated) *
The panel concluded that "heritable germline
genome editing trials must be approached with caution, but caution does not mean that they must be prohibited.
Also for Lynparza tablets, the FDA approved a new use (two tablets twice daily instead of eight capsules twice a day) and a new indication (women with deleterious or suspected deleterious germline
BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy).
Sometimes I feel like we're not on a slippery slope--we're flying off a cliff," Marcy Darnovsky, executive director of the Center for Genetics and Society, which opposes the use of human germline
modification for any purpose, told me recently.
engineering is controversial in itself.
This makes it more ethically complex, but there are strict regulations around human germline
genome editing, which is predominantly illegal.
That is a germline
effect, from a standard of care, somatic, effort.
A small proportion of ovarian cancers are attributable to genetic mutations, with approximately 10%-15% of cases caused by germline
mutations of BRCAl and BRCA2.
One goal of the research is to cure the disease of premature ovarian failure using female germline
stem cells, said senior author Ji Wu.