THE GENETIC INFORMATION IN YOUR HANDS
- Next Generation Sequencing provides a rapid, high-throughput and cost-effective approach to read the genetic information in our cells1,#
- Exome sequencing reports genetic alterations on all ~23.500 human genes and more specifically on their coding DNA sequence (~180.000 exons)2
- 85% of the mutations linked with genetic diseases are located on exome 3
A companion diagnostic device can be in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a particular therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.
BRACAnalysis® is a genetic test that confirms the presence of a BRCA1 or BRCA2 gene mutation. BRCA mutations are responsible for the majority of hereditary breast and ovarian cancers. People with a mutation in either the BRCA1 or BRCA2 gene have risks of up to 87% for developing breast cancer and up to 44% for developing ovarian cancer by age 70. Mutation carriers previously diagnosed with cancer also have a significantly increased risk of developing a second primary cancer. Genetic testing, specifically the BRACAnalysis test, identifies patients who have these mutations.