Companion Diagnostics
BRACAnalysis CDx is an FDA-approved laboratory developed test for BRCA1 and BRCA2 intended to inform patient management related to the PARP inhibitors, LynparzaTM (olaparib) and Zejula™ (niraparib).1,2,3
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 can safely forgoing chemotherapy.
myChoice® HRD is a test currently being developed by Myriad Genetic Laboratories, which seeks to identify patients whose tumor has Homologous Recombination Deficiency (HRD).
Hereditary Cancers
Myriad myRisk® Hereditary Cancer is a 28-gene panel that helps to determine a patient’s risk by evaluating a number of hereditary cancer syndromes, with focus on eight primary cancer sites.
The BRACAnalysis ® test assesses a person’s risk of developing hereditary breast or ovarian cancer based on the detection of mutations in the BRCA1 and BRCA2 genes.
COLARIS® testing assesses a person’s risk of developing hereditary colorectal cancer and a woman’s risk of developing hereditary uterine/endometrial cancer by detecting disease-causing mutations in the MLH1, MSH2, MSH6 and PMS2 genes.
COLARIS AP ® testing assesses a person’s risk of developing hereditary colorectal polyps and cancer by detecting mutations in the APC and MYH genes.
MELARIS® testing assesses a person’s risk of developing hereditary melanoma by detecting inherited mutations in the p16 gene (also called CDKN2A or INK4A ).
PANEXIA® testing assesses a person’s risk of developing hereditary pancreatic cancer by analyzing the PALB2 and BRCA2 genes, which are most commonly mutated in families with hereditary pancreatic cancer.
Lung Cancer
Myriad myPlan® Lung Cancer is a molecular diagnostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in early-stage non-small cell lung cancer.
Melanoma
Myriad myPath™ Melanoma is a unique molecular diagnostic test that analyzes 23 genes to assist in the timely and accurate diagnosis of melanoma.
Neuroscience
GeneSight is a clinically proven test to enhance medication selection for healthcare providers, helping them get their patients on the right medications faster. Powered by CPGxTM, GeneSight is a proprietary combinatorial pharmacogenomics technology that analyzes how an individual’s genetic variations affect his or her response to medications and provides an actionable, easy to interpret report. GeneSight is used by healthcare providers to help patients that are affected by neuropsychiatric conditions including depression, anxiety, bipolar disorder, schizophrenia, ADHD, posttraumatic stress disorder (PTSD) and other behavioral health conditions, as well as chronic pain.
Prostate Cancer
Prolaris® is a molecular diagnostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris® can be used in conjunction with other clinical parameters to determine prostate cancer aggressiveness.
Rheumatoid Arthritis
Vectra® DA is a multi-biomarker molecular blood test that simultaneously measures 12 key biomarkers to provide an objective and reproducible measure of rheumatoid arthritis (RA) disease activity.
Sources:
- 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 lynparza.com
- For more detailed information about Zejula and its safety and efficacy please go to zejula.com
Lynparza is a trademark of the AstraZeneca group of companies, Zejula is a trademark of Tesaro, Inc.
