News and reporting on ovarian cancer.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
OvaCis is a CE-IVD marked in vitro diagnostic that can be used to assess epithelial ovarian cysts.
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.
Palmetto has expanded the local coverage determination for the Guardant360 liquid biopsy assay to be used with the majority of advanced solid tumors.
The company's +RNAinsight test, a combined DNA and RNA genetic test for hereditary cancer syndromes, was launched in October.
The guidelines place a stronger emphasis on pancreatic cancer risk genes, and broaden testing recommendations for those with Ashkenazi Jewish ancestry.
CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.