SAN DIEGO, CA – September 10. 2014 – Pathway Genomics Corporation, a San Diego-based CLIA and CAP accredited clinical laboratory that offers genetic testing services globally, today announced it has launched BreastTrueTM High Risk Panel, a next-generation sequencing test with deletion/duplication analysis to detect mutations in seven high-risk breast cancer susceptibility genes, including BRCA1, BRCA2 and PALB2.
Recent studies of breast cancer survivors have shown that approximately 70 percent of the mutations identified were BRCA1/2 mutations. Approximately 4 percent had germline mutations in other cancer-susceptibility genes, including high-risk genes. These additional high-risk genes include CDH1, PALB2, PTEN, STK11, and TP53. Pathway Genomics’ BreastTrue High Risk Panel analyzes all of these genes.
“The development and launch of this breast cancer high risk panel is a necessity to effectively serve physicians and their patients,” said Jim Plante, Pathway Genomics’ founder and CEO. “Our mission is clear and precise. We exist to provide the most accurate and comprehensive genetic tests to the medical community, and we will continue to innovate.”
Conditions such as Li-Fraumeni, Cowden, Peutz-Jeghers, and hereditary diffuse gastric cancer (HDGC) syndromes have been associated with a significantly increased risk for breast cancer, and genetic testing of the genes associated with these conditions (i.e., TP53, PTEN, STK11 and CDH1) has been an important part of the clinical management of patients with a family history of breast cancer. Most recently, a large study published in the New England Journal of Medicine has also affirmed mutations in the PALB2 gene as important contributors to breast cancer risk.
“BreastTrue is the first breast cancer high risk panel in the industry that includes PALB2 full gene sequencing,” said Ardy Arianpour, Pathway Genomics’ chief strategy officer. “Cancer centers, genetic counselors and our current ordering clinicians have been asking us to deliver this type of product since our entry into this market.”
In addition to releasing BreastTrue High Risk Panel, Pathway has also enhanced its existing BRCATrueTM test to include single site, reflex testing, and BRCATrue Ashkenazi Jewish (3-site). The addition of reflex testing allows clinicians to appropriately utilize panel testing without creating unnecessary costs for patients and insurance companies.
To learn more about BreastTrue High Risk Panel with PALB2, visit www.pathway.com/breasttrue.