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The diagnostic will be covered when patients are tested according to the Japanese Organization of Hereditary Breast and Ovarian Cancer's criteria.
The large BRCA1 deletion, which was not captured by initial genetic testing, might be the reason for the patient's exceptional response to a PARP inhibitor.
Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.
Many companies and counselors see the COVID-19 pandemic as a catalyst for moving germline risk testing into a digital-first healthcare model.
The group now states that men with unfavorable intermediate-risk or high-risk disease can consider testing with Myriad's Prolaris or GenomeDx's Decipher.
The intended use will be in newly diagnosed ovarian cancer patients who are responsive to platinum chemotherapy regardless of biomarker status.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
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.
Among the firms presenting, drugmakers, speciality biotechs, and genetic testing firms provided an update on their precision oncology development programs.