The service, named BRCAvantage Plus, will be available in all the 50 US states and its launch reflects the commitment of Quest Diagnostics DGX o giving physicians and patients access to clinically important diagnostic insights into cancer risk, senior vice president Jon R. Cohen said.
BRCAvantage Plus is the first major line extension to BRCAvantage, a suite of lab-developed tests for assessing BRCA1 and BRCA2 gene mutations launched in October 2013. It screens for mutations in the BRCA1 and BRCA2 genes as well as in five additional genes, namely TP53, PTEN, CDH1, STK11, and PALB2.
Individuals who test positive for a mutation may consider more intensive monitoring or medical or surgical intervention to decrease risk of death from cancer in conjunction with their physician and in consideration of medical evidence and guidelines.
The BRCAvantage family of services is based on next-generation gene sequencing and multiplex ligation-dependent probe amplification, for analytical sensitivity and specificity of over 99.99% in the company's assay validation study.
Quest Diagnostics is also participating in ongoing collaborative studies to further the understanding of specific mutations together with leading academic medical centers, including Memorial Sloan Kettering Cancer Center in New York.
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