Myriad Genetics (MYGN) Announces Positive Results from BRACAnalysis CDx Test

October 26, 2016 7:18 AM EDT

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Myriad Genetics, Inc. (Nasdaq: MYGN) announced that its BRACAnalysis CDx test accurately identified patients who may benefit from treatment with olaparib. The BRACAnalysis CDx test was included in the SOLO2 study (NCT01874353) as a diagnostic with olaparib, an oral PARP inhibitor being developed by AstraZeneca (Nasdaq: AZN).

SOLO2 compared maintenance olaparib against placebo in patients with platinum-sensitive relapsed ovarian cancer. In this study, patients were tested for germline BRCA (gBRAC+) mutations as determined by Myriad’s BRACAnalysis CDx test. The primary endpoint for SOLO2 was progression-free survival (PFS). The aim was to determine whether patients carrying gBRAC mutations treated with olaparib as a second-line maintenance therapy experienced longer progression-free survival, compared to those patients receiving placebo. The results showed that the olaparib-treated patients achieved the primary endpoint of prolonged PFS.

“These outstanding findings represent another meaningful advancement for ovarian cancer patients,” said Johnathan Lancaster, M.D., Ph.D., gynecologic oncologist and chief medical officer of Myriad Genetic Laboratories. “Importantly, the results demonstrated that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy.”

The collaboration between Myriad and AstraZeneca on olaparib began in 2007. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test reviewed and approved by the FDA.

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 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 laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.



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