TEST:

Ki-67 IHC MIB-1 pharmDx

In conclusion, FNA samples of canine MCTs can often yield adequate cell numbers for FC analysis, and a multicolor FC panel was developed that can detect Ki-67 in canine mast cells. This would permit further studies into the potential use of this panel for canine cutaneous and subcutaneous MCT prognostication purposes.

P=N/A; Active, not recruiting --> Completed

There was no statistical difference in mean Ki67% between CNB, RES, and LN specimens using the weighted Ki67 scoring protocol; however, 9 patients in our cohort (18%) would have treatment changes based on which specimen was chosen for analysis and 13 (25%) whether manual or automated counting was performed. To ensure reproducible eligibility assessment, further refinement in scoring Ki67% is needed.

Recently, cyclin-dependent kinases 4/6 inhibitor called abemaciclib, has been approved for high risk patients after surgery, together with Ki-67 IHC MIB-1 pharmDx(Dako Omnis) for the patient selection... Here, we have created a fully automated software to analyze Ki-67, which includes DL-based algorithm to detect invasive BC nest and count a large amount of cells quickly. It has probed to have concordant result with experienced breast pathologists, although the prognostic value needs to be confirmed. As the software tend to have lower value than pathologists, we have to pay attention to the cut-off value .

Digital evaluation of Ki-67 appears to play an independent role in the progression of UM. This objective method is a promising tool for better prognostic stratification of UM patients.

In our cohort, PharmDx clone is not superior to MIB1 stain and either of the clones can be used in the clinical laboratory to direct therapy with Abemaciclib. Considering the weak staining of Ki-67 (1+) increases the final score and consequently the number of eligible patients for Abemaciclib, the benefit from treatment is unclear. Validation of different clones in the clinical laboratories is warranted.

UNWT and WT trend toward better interobserver variability compared to the EST. Count differences between pathologists that would have led to treatment difference were minimized using the WT protocol; however, this was not statistically significant when sorted by specimen type. Overall, our study suggests that further refinement in Ki67% scoring is advisable to reduce clinically significant manual score variation.

The moderately positive correlation is consistent with previous analyses suggesting the Oncotype Dx® assay and Ki-67 IHC MIB-1 assay should not be used interchangeably in clinical practice.

Background Ki67 immunohistochemistry (IHC) with a cut-off of 20% by MIB-1 PharmDx assay has been approved as a companion diagnostic for adjuvant abemaciclib in high-risk ER+HER2- breast cancer...Conclusions Although about 60% of tumors with high Ki67 expression had low genomic risk by 21-gene multigene assay, the patients with high Ki67 have a substantial risk of relapse regardless of genomic risk. In high Ki67 tumors with PR+ and/or lower histologic grade, the multigene assay would be useful to evaluate their genomic risk.

Background: In monarchE, abemaciclib, an oral CDK4/6 inhibitor, when combined with endocrine therapy (ET, tamoxifen or aromatase inhibitor) significantly improved invasive disease-free survival in patients with HR+, HER2-, node positive early breast cancer (EBC) at high risk of early recurrence and Ki-67 score ≥20%. A moderately positive correlation between the Oncotype DX Breast Recurrence Score result and the Ki-67 IHC MIB-1 pharmDx Score in HR+, HER2- node positive EBC was observed in the All-RS pool. These findings are consistent with prior studies.