Study Describes Design, Validation of Foundation Medicine's Blood-Based TMB Test

NEW YORK (GenomeWeb) – Researchers from Genentech, Foundation Medicine, UC Davis, and other medical centers, have published a report on the development and early validation of Foundation’s planned blood-based tumor mutational burden test.

Appearing today in Nature Medicine, the study describes the development of the test and its characteristics, and its retrospective validation in two cohorts. Investigators demonstrated, by applying the assay to samples from two clinical trials, that blood-based TMB (bTMB) could reproducibly identify lung cancer patients who respond to immunotherapy treatment with Roche/Genentech’s atezolizumab (Tecentriq).

Foundation Medicine announced its intentions late last year to develop a blood-based version of its existing tissue TMB test as a companion diagnostic to atezolizumab in first-line treatment of non-small cell lung cancer patients.

Investigators had previously presented some of the data from the newly published study at the European Society for Medical Oncology Congress in Madrid last September. And Foundation said at the time that the bTMB test was being further studied in two ongoing clinical trials — B-F1RST and BFAST.

More recently, the US Food and Drug Administration granted a Breakthrough Device designation for an expanded version of Foundation Medicine’s existing FoundationACT liquid biopsy test to include assessment of microsatellite instability

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