The final national coverage decision stipulates that NGS germline tests for assessing hereditary breast and ovarian cancer risk must have FDA's blessing.
Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.
Natera discussed its cancer and transplant rejection testing businesses, while Exact Sciences explained how it will benefit from its Genomic Health acquisition.
The guidelines place a stronger emphasis on pancreatic cancer risk genes, and broaden testing recommendations for those with Ashkenazi Jewish ancestry.
