Making a decision on treatment options for patients diagnosed with early-stage breast cancer is an important choice and one that should be made with the best information possible. EndoPredict® can help accurately determine an individual patient’s 10-year risk of recurrence to help physicians identify which patients may consider safely forgoing chemotherapy.
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
The PrequelTM prenatal screen is a non-invasive test that you can take as early as 10 weeks into your pregnancy to learn about your baby’s chance to have a chromosome condition like Down syndrome.
- 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.
- For more detailed information about Lynparza and its safety and efficacy please go to lynparza.com
- 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.