TEST:

Idylla™ MSI Test

This is the largest study evaluating Idylla on archival FFPE material. High concordance with traditional methods suggests that Idylla can be used as an alternative approach for Lynch syndrome screening, improving accessibility and reliability of MSI and BRAF testing in challenging archival specimens.

"The Idylla CDx MSI Test aids in identifying eligible microsatellite instability-high (MSI-H) colorectal cancer (CRC) patients, who may benefit from treatment with OPDIVO (nivolumab) alone, or in combination with YERVOY (ipilimumab), as established in the CheckMate-8HW trial..."

Molecular evaluation should be standard practice in all endometrial carcinoma cases exhibiting subclonal loss of MMR proteins to accurately delineate tumor characteristics. Subclonal loss should be reported distinctly, warranting a more comprehensive diagnostic approach to enhance tumor classification.

"Seven abstracts from leading research and academic institutions will be presented as posters, highlighting the rapid, fully automated molecular testing capabilities of the Idylla Platform across several different cancer types, including lung cancer, thyroid cancer, endometrial carcinoma and colorectal cancer. Biocartis also continues to focus on melanoma, blood, brain and breast cancer."

Pre-analytic evaluation of the manufacturer's recommended 20% tumor content cut-off is essential to ensure valid results. The Idylla MSI assay offers several advantages over other PCR-based assays including minimal hands-on time, rapid turn-around-time, no requirement for a paired normal sample and the use of FFPE directly without an extraction step.

Via the analysis of longer homopolymer repeat regions, the Promega LMR MSI assay demonstrates enhanced sensitivity for subtle phenotypes. This assay may be better suited than other PCR- and CE-based approaches for certain disease types.

Both assays showed comparable sensitivity in establishing MSI status for CRC and the expanded spectrum of non-CRC tumors. Advantages such as increased number of LMR loci in the Promega assay and the need for only tumor specimen in the Idylla assay increase the utility of these assays in determination of MSI status in a variety of cancers.

MSI appears to be insignificant in SGCs. Larger cohorts are needed for verification.

Performance of the Idylla test was better correlated with MMR genomic status than MMR immunohistochemistry status, which improved with a modified test cut-off. Further studies are needed to confirm the cut-off accuracy.

Idyllaâ„¢ MSI showed a very high OPA with the gold standard MSI test and with MMR IHC. In view of its short turnaround time and ease of use, this test could therefore be an excellent alternative for MSI testing in endometrial cancer, even with old tissue samples.

Overall, we found that the Idyllaâ„¢ MSI works well as a screening method for dMMR with no false-positive cases detected. The proposed algorithm was useful and easily applicable.

Our prelimary data suggest that sAS discloses an immunosuppressive environment; therefore, compared to pAS, sAS might be a better candidate to immunotherapy.