By Diagnostics World Staff
December 7, 2018 | Insight Genetics has launched 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 is the first CLIA-validated assay for TNBC molecular subtyping, and the company believes it will 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 today.
“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, in a statement. “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 US 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.”
Historically, TNBC has been defined as tumors that are negative for ER, PR, and HER2 expression, and comprises up to 15-20% of all breast cancers. TNBC is an aggressive disease with a higher risk of both local and distant recurrence compared to patients with other types of breast cancer.
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 Insight TNBCtype 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. Insight Genetics has worked extensively to refine the TNBC classification algorithm to maximize its potential for clinical use by reducing the number of genes from over 2,000 down to 101, allowing heterogeneous tumors to be classified by more than one subtype, and optimizing the test for use on single patient samples.
For existing standard of care chemotherapy treatments, two published studies have demonstrated the need to understand the TNBC molecular subtypes, especially for BL1 and BL2 patients. The Clinical Cancer Research paper “Differential Response to Neoadjuvant Chemotherapy among Triple-Negative Breast Cancer Molecular Subtypes” highlights BL1 patients who received neoadjuvant taxane and anthracycline-based therapy had a pathological complete response (pCR) rate of 52 percent, while BL2 patients had a zero percent pCR (Masuda, et.al. 2013). The PLoS One paper “Refinement of Triple-Negative Breast Cancer Molecular Subtypes: Implications for Neoadjuvant Chemotherapy Selection” demonstrated that TNBC subtypes significantly differ in response to similar neoadjuvant chemotherapy with 41 percent of BL1 patients achieving pCR, while only 18%t for BL2 (Lehmann, et. al. 2016).