Last month, Nashville-based Insight Genetics, Inc. announced the launch of its proprietary Insight TNBCtype™, a new test for categorizing triple negative breast cancer (TNBC) tumors into distinct molecular subtypes through its wholly owned CLIA- and CAP-accredited lab, Insight Molecular Labs. Insight TNBCtype, the first and only CLIA-validated assay for TNBC molecular subtyping, is anticipated to enable prospective clinical trials with pharmaceutical, biotechnology, and academic medical institutions and advance targeted therapies for TNBC patients, addressing a significant unmet need in oncology.
"Triple negative breast cancer has long been a challenge for oncologists and the patients they treat because there are few proven treatment options," said Eric Dahlhauser, Insight Genetics chairman and CEO. "It is our hope that Insight TNBCtype will advance treatment and diagnosis of this disease, improving the lives of the 35,000 diagnosed patients in the U.S. each year. We believe this test can further enable clinical trial testing and ultimately become the standard of care for TNBC patients, bringing TNBC into the age of precision medicine."
TNBC, which comprises up to 15-20 percent of all breast cancers, has been historically defined as tumors that are negative for ER, PR, and HER2 expression. Insight TNBCtype was developed from years of collaborative studies with leading academic research investigators, pharmaceutical and biotech companies and advances the seminal work in TNBC molecular subtyping by Jennifer Pietenpol, PhD and Brian Lehmann, PhD at Vanderbilt University, with which Insight Genetics has a global exclusive license. The new Insight test is based on a proprietary algorithm that uses gene expression data from next-generation sequencing to generate five molecular subtypes (BL1, BL2, LAR, MSL and M), as well as a complementary immunomodulatory (IM) classifier that may help predict response to immuno-oncology therapies.