The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
The company attributed its revenue shortfall to billing issues in the prenatal testing business and announced that CFO Bryan Riggsbee will be interim CEO.
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.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
On Monday Qiagen reiterated its preliminary 2019 earnings figures and addressed an investor's wrath, while Guardant Health highlighted its cancer testing plans.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.
The company plans to make its PRS offering, currently used only in those who test negative for gene mutations, an option for all customers of European ancestry.
The firm is adding data on patient risk for radiographic progression and cardiovascular events to the test, which was recently included in the ACR guidelines.
Of the 28 companies in the index, 21 companies' share prices increased while the share values of 7 declined month over month.
Investigators compared expression in different men across the genes from three commercial panels, arguing that the findings highlight important unknowns.