Myriad Genetics launches early stage breast cancer test in US

Myriad Genetics announced that it has launched the EndoPredict® test in the United States for patients with ER+ HER2- early-stage breast cancer.  EndoPredict is a second-generation test for assessing the 10-year risk of disease recurrence following surgery and for determining which patients can safely forgo adjuvant chemotherapy.

“Today’s launch strengthens our oncology product portfolio and represents a meaningful advancement in the treatment of patients with breast cancer,” said Lloyd Sanders, general manager, Oncology, Myriad Genetic Laboratories.  “Along with our best-in-class tests for hereditary cancer and our companion diagnostics, the launch of EndoPredict underscores our commitment to pioneering science, personalized medicine and patient care.”

EndoPredict is supported by multiple prospective clinical studies and data from more than 3,500 patients with ER+ HER2- node negative and node positive early-stage breast cancer.  The results of the clinical development program show that EndoPredict substantially outperforms the first generation breast cancer recurrence tests.  EndoPredict was trained and validated using 10-year outcomes data and includes proliferation-related genes as well as hormone receptor-related genes, providing accurate assessment of early and late risk for recurrence and definitively classifies patients as low or high risk.

“Breast cancer is a complicated disease and there is a critical need for accurate breast cancer recurrence tests that help physicians determine which patients can safely forgo adjuvant chemotherapy,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories.  “The launch of EndoPredict is an important advancement for patients and doctors.  By automatically incorporating clinical features and generating an individualized patient test result, EndoPredict identifies a larger subset of true low-risk patients who may safely forgo adjuvant chemotherapy.”

EndoPredict already is included in medical guidelines including the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO) and the St. Gallen International Breast Conference.  Additionally, the Integrated Oncology Network (ION) named EndoPredict as its preferred breast cancer recurrence test.  Myriad is working with payers to making sure EndoPredict is a widely accessible to patients.  So far, the test has received positive coverage decisions from 19 payers, bringing total coverage to over 70 million patients in the United States.

Source: Myriad Genetics