2024
Training pathologists to assess stromal tumour‐infiltrating lymphocytes in breast cancer synergises efforts in clinical care and scientific research
Ly A, Garcia V, Blenman K, Ehinger A, Elfer K, Hanna M, Li X, Peeters D, Birmingham R, Dudgeon S, Gardecki E, Gupta R, Lennerz J, Pan T, Saltz J, Wharton K, Ehinger D, Acs B, Dequeker E, Salgado R, Gallas B. Training pathologists to assess stromal tumour‐infiltrating lymphocytes in breast cancer synergises efforts in clinical care and scientific research. Histopathology 2024, 84: 915-923. PMID: 38433289, PMCID: PMC10990791, DOI: 10.1111/his.15140.Peer-Reviewed Original ResearchStromal tumor-infiltrating lymphocytesTumor-infiltrating lymphocytesUS Food and Drug AdministrationFood and Drug AdministrationBreast cancerPathologist's visual assessmentDrug AdministrationSignificant interobserver variabilityPredicative biomarkerTILs assessmentTrained pathologistsInterobserver agreementInterobserver variabilityVisual assessmentGold standardReference standardBreastCME coursesClinical practiceClinical careCancerMedical educationPathologistsLymphocytesExpert commentary
2023
Initial interactions with the FDA on developing a validation dataset as a medical device development tool
Hart S, Garcia V, Dudgeon S, Hanna M, Li X, Blenman K, Elfer K, Ly A, Salgado R, Saltz J, Gupta R, Hytopoulos E, Larsimont D, Lennerz J, Gallas B. Initial interactions with the FDA on developing a validation dataset as a medical device development tool. The Journal Of Pathology 2023, 261: 378-384. PMID: 37794720, PMCID: PMC10841854, DOI: 10.1002/path.6208.Peer-Reviewed Original Research