Why Test with BRACAnalysis CDx?

BRACAnalysis CDx
olaparib, Lynparza naraparib, zejula
 
Mutations in BRCA1 or BRCA2 cause Hereditary Breast and Ovarian Syndrome (HBOC). Now mutations in the BRCA1 and BRCA2 genes provide an indication for treatment with Lynparza™ (olaparib) for patients with ovarian cancer. Specifically, BRACAnalysis CDx® is the only FDA-approved laboratory developed test approved to be used with the PARP inhibitor, Lynparza. A positive BRACAnalysis CDx result in patients with ovarian cancer is also associated with enhanced progression-free survival (PFS) from Zejula™ (niraparib) maintenance therapy 1,2,3

~15% of patients with epithelial ovarian cancer are BRCA positive3,4

15%

69% of BRCA-positive patients with ovarian cancer are diagnosed over the age of 503

69%

44% of BRCA-positive patients with ovarian cancer had NO family history of cancer3

69%

Unfortunately, ONLY 25% of patients newly diagnosed with ovarian cancer know their BRCA status, even though NCCN has recommended BRCA1 and BRCA2 testing for all patients with epithelial ovarian cancer since 2008.

% of Newly-Diagnosed Patients with Ovarian Cancer Tested in Each State in 2013

Ovarian Cancer heat map

Even in states with the highest testing rates, OVER 50% of patients were NOT TESTED within a year of diagnosis

† Herzog et al. SGO 2015

  1. Intended Use: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, who are or may become eligible for treatment with Lynparza™ (olaparib). Detection of deleterious or suspected deleterious germline BRCA 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 320 Wakara Way, Salt Lake City, UT 84108.
  2. For more detailed information about Lynparza and its safety and efficacy please go to www.lynparza.com
  3. For more detailed information about Zejula and its safety and efficacy please go to www.zejula.com
  4. Alsop, K. et al. (2012) BRCA mutation frequency and patterns of treatment response in BRCA mutation-positive women with ovarian cancer: a report from the Australian Ovarian Cancer Study Group. J. Clin. Oncol., 30, 2654–2663.
Lynparza is a trademark of the AstraZeneca group of companies. Zejula is a trademark of Tesaro, Inc.

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