First to assess BRCA status

SALT LAKE CITY—Myriad Genetics Inc. has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza (olaparib). Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic for use with a novel PARP inhibitor.

Ron Rogers, Myriad’s executive vice president of corporate communications, explains that germline mutations are those that are inherited. Such a circumstance was what impelled Angelina Jolie to have a prophylactic double mastectomy based her family history.

“Myriad is excited to offer the first and only FDA-approved companion diagnostic for Lynparza, which we believe opens a new door in personalized medicine and represents a big step forward in tailoring treatment for women with ovarian cancer,” said Mark Capone, president of Myriad Genetic Laboratories. “Less than 25 percent of ovarian cancer patients know their germline BRCA status, which is critical for any ovarian cancer patient who may be considered for treatment with Lynparza.”

BRACAnalysis CDx is reportedly a highly accurate molecular companion diagnostic test that identifies deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes, using DNA obtained from a blood sample. BRACAnalysis CDx was shown in clinical studies to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The approval of BRACAnalysis CDx demonstrates Myriad’s commitment, the company says, to developing companion diagnostics and is the culmination of an intensive, multiyear scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer.

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 ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single FDA-approved laboratory site located in Salt Lake City.

“Myriad has proven its ability to navigate a rigorous FDA regulatory approval process that included a comprehensive review of our DNA sequencing, large rearrangement detection and variant interpretation processes. Patients can be confident their BRACAnalysis CDx test results from Myriad are highly accurate,” said Capone. “Our scientific excellence, reputation for high quality and regulatory experience are key reasons why Myriad is fast becoming the partner of choice for many biopharmaceutical companies seeking to co-develop companion diagnostic tests. We hope to expand our collaborations and further diversify our product portfolio.”

One example of such expansion is being developed for the European market—a BRACAnalysis using tumor tissue that will be valid for both inherited and so-called sporadic mutations caused by errors in cell division or by environmental damage. Rogers estimates that this test may identify up to 44 percent more patients eligible for Lynparza than would be identified by the blood test alone.

Myriad Genetics is actively collaborating with several biopharmaceutical companies to further evaluate BRACAnalysis CDx as an investigational companion diagnostic for use with other PARP inhibitors and chemotherapeutic agents and for use in many other solid tumor types.