Myriad Genetics Ending Patent Dispute on Breast Cancer Risk Testing

Myriad Genetics has essentially given up trying to stop other companies from offering tests for increased risk of breast cancer, ending a dispute that was the subject of a landmark Supreme Court ruling that human genes cannot be patented.

“The company has settled or is in the process of settling patent-infringement lawsuits it filed against other companies that now offer such testing, a Myriad spokesman said on Tuesday.

“Myriad’s lucrative monopoly on testing for mutations in two genes linked to an increased risk of breast and ovarian cancer ended in 2013, when the Supreme Court ruled that human genes were not eligible for patents because they were products of nature.

“Numerous laboratories began offering tests, some for much less than the roughly $4,000 Myriad charged for a complete analysis of the two genes, known as BRCA1 and BRCA2.

“Myriad sued many of those companies, saying they were infringing other patent claims that had not been invalidated by the Supreme Court.”

Myriad myPath(TM) Melanoma Improves Diagnosis and Treatment Plans

The gist: It can be difficult for doctors to tell whether a patient has malignant melanoma or simply a benign mole. A test called myPath Melanoma uses molecular testing to help clarify whether or not a person has melanoma. Researchers recently finished a study to look at the effectiveness of the test. They found that doctors who used MyPath Melanoma had 43% fewer cases of indecision, and changed their mind about treatment recommendations 49% of the time.

“Myriad Genetics, Inc. (Nasdaq:MYGN) today presented results from a prospective clinical utility study of its Myriad myPath Melanoma test at the 2014 American Society of Dermatopathology (ASDP) annual meeting in Chicago, Ill. Myriad myPath Melanoma is a genetic test that differentiates malignant melanoma from benign skin lesions across all major melanoma subtypes. Key findings of this clinical utility study included a 43 percent reduction in indeterminate diagnoses and a 49 percent change in physicians’ treatment recommendations for patients.

” ‘These findings demonstrate the power of Myriad myPath Melanoma to improve patient care through more definitive diagnoses of skin lesions, particularly in these difficult-to-call cases,’ said Loren Clarke, M.D., vice president of Medical Affairs at Myriad Genetic Laboratories. ‘Importantly, the number of indeterminate cases was significantly reduced, which means less uncertainty for more patients and physicians, and may lead to less overtreatment in these cases.’ ”

“The study evaluated the impact of the Myriad myPath Melanoma diagnostic test on dermatopathologists’ diagnoses and intended treatment recommendations for 218 patients with pigmented skin lesions that were considered difficult to diagnose. The dermatopathologists recorded their diagnoses and treatment plans before and after receiving the myPath Melanoma test results.”

Tumor BRCA Dx Could ID More Responders to PARP Inhibitors; Myriad Expects Initial Launch in Europe

The gist: Breast cancer patients with BRCA mutations could potentially be treated with new drugs called PARP inhibitors. In many cases, BRCA mutations are inherited, and are therefore found in all cells in the body. But a patient who did not inherit a BRCA mutation might still develop a mutation in a small number of cells, which might grow into a breast cancer tumor. Indeed, patients with ovarian and breast cancers have been identified who have BRCA mutations in their tumors only, but not in normal cells. Testing for BRCA mutations in tumor tissues could help identify more people who might benefit from treatment with PARP inhibitors.

“A comparison of germline BRCA mutation testing against a new diagnostic developed by Myriad Genetics that can gauge somatic mutations revealed that the latter was able to pick up 44 percent more deleterious markers in women with ovarian cancer.

“In identifying additional mutation carriers, Myriad hopes its so-called Tumor BRACAnalysis CDx will be able to identify more responders PARP inhibitors. The company has long-term plans to launch somatic BRCA mutation testing as a companion diagnostic first in Europe and then in the US.

“Germline mutations show up in all cells of the body, but a blood test that gauges just these mutations can miss some patients who acquire mutations only in their tumor. Gauging somatic mutations usually requires a test that analyzes markers in tumor tissue samples.

“At the European Society for Medical Oncology’s annual meeting in Madrid, Spain this week, researchers from Myriad and MD Anderson Cancer Center described a study analyzing approximately 130 previously untreated, high-grade ovarian cancer patients for germline BRCA mutations in blood samples and somatic mutations in tissue samples. In the study, the researchers also tested patients undergoing surgery for both of these types of mutations, and they performed germline testing using a custom amplicon assay and next-generation sequencing.”