Personalized medicine — also known as targeted medicine or precision medicine — is a rapidly-evolving area of healthcare in which the treatment for a medical condition such as cancer is tailored to the individual patient and his or her biology. There should not be a one-size-fits-all approach to medicine. The goal of personalized medicine is to prescribe the right medicine for the right patient at the right time.
Companion diagnostics are medical tests that make personalized medicine possible. Designed to be paired with a specific drug , companion diagnostics help healthcare professionals determine which patients could be helped by that drug and which patients would not benefit, or could even be harmed.
Unlike other laboratory developed tests, companion diagnostics are reviewed and approved by the U.S. Food and Drug Administration (FDA), which is the gold standard for ensuring safety, effectiveness and quality. FDA approval gives physicians confidence they are receiving the highest quality test result on a consistent basis.
BRACAnalysis® CDx is an FDA-approved laboratory developed test for BRCA1 and BRCA2 intended to inform patient management related to the PARP inhibitors, Lynparza® (olaparib) and Zejula® (niraparib).1,2,3
Information for Physicians
Information for Patients
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 breast and 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 lynparza.com
3. For more detailed information about Zejula and its safety and efficacy please go to zejula.com
Lynparza is a registered trademark of the AstraZeneca group of companies. Zejula is a registered trademark of Tesaro, Inc.
***U.S. Food and Drug Administration. Personalized medicine and companion diagnostics go hand-in-hand. Available at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm407328.htm.