BRACAnalysis versus BRACAnalysis CDx
Both BRACAnalysis and BRACAnalysis CDx sequence the BRCA1 and BRCA2 genes to determine if there are mutations in either of these genes.
BRACAnalysis CDx is the only FDA approved laboratory developed test (LDT) that indicates whether or not a patient with ovarian cancer may be appropriate for treatment with Lynparza™ (olaparib).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
- 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.
- For more detailed information about Lynparza and its safety and efficacy please go to www.lynparza.com
- For more detailed information about Zejula and its safety and efficacy please go to www.zejula.com