Foundation Medicine recently announced a companion diagnostic partnership with Syndax Pharmaceuticals to identify AML patients with NPM1 mutations with comprehensive genomic profiling, which, if approved, could be the first NGS CDx test to detect genomic alterations in hematologic neoplasms.
With advance planning and a diagnostics partner with demonstrated regulatory expertise, it is possible to navigate EU IVDR requirements with confidence and keep clinical trial timelines on track.
Explainable artificial intelligence, or XAI, is enabling Baylor Genetics to hasten and scale up clinical whole-genome sequencing while testing becomes more accessible and evidence for its utility grows.
Artificial intelligence models that can explicitly demonstrate their logic and expose potential biases, known as explainable AI, or XAI, are necessary for medical institutions to make healthcare decisions with increased confidence, according to Illumina.
Epigenetics is the key to unlocking the full potential of cancer therapy, including immunotherapies, by revealing deep insights into how the body reacts and responds to medication.
Foundation Medicine and Flatiron Health are introducing a novel capability for supporting companion diagnostic regulatory filings with real-world data from the Flatiron Health-Foundation Medicine Clinico-Genomic Database.
In this Q&A, Igor Genkin, medical director at Salem Regional Cancer Center, discusses a minimally invasive test detecting 3D genomic markers that returns a binary result to the ordering physician with high accuracy: “low probability” or “high probability” of response to any immune checkpoint inhibitors.
Cell therapy has the potential to create highly innovative, life-changing medicines with never-before-achieved therapeutic and curative potential, but fragmented processes and inefficient data management can slow down cell therapy pipelines.