On July 31, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, reported that Medicare has expanded coverage for BRACAnalysis CDx for men with prostate cancer who are eligible or may become eligible for treatment Lynparza (olaparib). BRACAnalysis CDx is the only germline test covered for this indication (Press release, Myriad Genetics, JUL 31, 2020, View Source [SID1234562626]).
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"One in six patients with prostate cancer have a hereditary form of the disease and are six times more likely to die from it within five years," said Nicole Lambert, president of Myriad International, Oncology and Women’s Health. "Providers with earlier knowledge of their patient’s germline status can help tailor treatments and can provide eligibility for life-sustaining therapies should they progress to metastasis. Additionally, the information can be provided to the patient’s family members to prevent future cancers."
According to the American Cancer Society, 191,930 new cases of prostate cancer occur every year and approximately 33,330 men will die from the disease this year. In May, the U.S. Food and Drug Administration (FDA) approved the BRACAnalysis CDx test for use as a companion diagnostic tool by healthcare professionals to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Lynparza (olaparib). Lynparza, a non-chemotherapy oral medication, is approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.
About BRACAnalysis CDx
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza (olaparib). Detection of deleterious or suspected deleterious germline BRCA1 and BRCA2 variants by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula (niraparib) maintenance therapy. This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108. Learn more at View Source