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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.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
SpeeDx said it will work with GlaxoSmithKline on tests to support its antibiotic clinical trials, as well as its new product development efforts.
The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.
GSK will use the Breath Biopsy to assess whether the right treatment for the right patient can be identified, and to evaluate its drug candidate for COPD.