Natera will present two posters: one from the I-SPY2 Trial describing Signatera's performance as a predictive biomarker for response to neoadjuvant immunotherapy, and the other from the Beyond BRCA study describing Natera's plasma-based whole exome analysis as a tool for tracking clonal evolution and discovering new treatment resistance mutations.
Details about the presentations are as follows:
Poster #PD9-02 | Spotlight Poster Discussion
Personalized ctDNA as a predictive biomarker in high-risk early stage breast cancer treated with neoadjuvant chemotherapy (NAC), with or without pembrolizumab
A study from the prospective, randomized I-SPY2 Trial exploring the predictive value of personalized ctDNA analysis, performed by Natera, in patients with early-stage breast cancer undergoing either standard NAC or NAC in combination with the immune checkpoint inhibitor pembrolizumab. Early clearance of ctDNA (three weeks after initiation of treatment) is significantly associated with achieving pathological complete response, and may serve as an early surrogate marker for response to therapy. Persistent presence of ctDNA after completion of NAC, but prior to surgery, is strongly correlated with poor disease-free survival.
"Just last week, the I-SPY investigators published a paper in Annals of Oncology validating Signatera's performance in neoadjuvant treatment monitoring for patients with early-stage breast cancer," said
Poster #PD10-12 | Spotlight Poster Discussion
Genomic analysis from the Talazoparib Beyond BRCA clinical trial: homologous recombination deficiency (HRD) scores, loss-of-heterozygosity and mutations in non-BRCA 1/2 mutant tumors
A poster on the genomic characterization of treatment response and resistance to the PARP1 inhibitor, talazoparib, in non-BRCA 1/2 mutant tumors with mutations in other HRD-associated genes. Plasma-based whole exome sequencing of ctDNA, performed by Natera, provides a comprehensive view of tumor evolution over the course of treatment, wherein responders and nonresponders show distinct patterns, leading to the identification of novel mutations responsible for acquired resistance to talazoparib treatment.
"Drug resistance remains a significant challenge in the management of breast cancer," said
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the
Natera is a pioneer and global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in
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