TEST:

Idylla™ IDH1-2 Mutation Assay

Determination of IDH1-2 mutation status is important for a variety of malignancies for diagnostics, classification, prognosis, and therapy selection. The Idylla system is easy to use and requires little training; therefore, it is the ideal assay to implement in a variety of labs. Overall, the Idylla platform provides quick, dependable, and easy-to-use technology for performing this analysis.

The Idylla IDH1-2 Mutation Assay Kit performed on the Biocartis Idylla system demonstrated a rapid and cost-effective alternative to the standard approaches. This assay can be used to evaluate clinically relevant IDH variants in a much shorter turnaround time and from limited biological samples, which makes this a preferred technique to develop clinical tests for diagnosis, prognosis, and evaluation of treatment in AML.

These mutations are targetable using agents such as ivosidenib and vorasedinib in AML... The Biocartis Idylla IDH1-2 mutation assay shows good concordance with ddPCR and an LOD of 2.5% VAF. Though the analytical sensitivity of this assay is lower than ddPCR, this may not be a limitation in acute, newly diagnosed patients presenting with increased blast counts. This assay offers the advantage of direct specimen testing for PB and BM without DNA extraction with faster turnaround time than other methods.

The Idyllaâ„¢ IDH1-2 Mutation Assay demonstrates high sensitivity and specificity in detecting IDH1-2 mutations in gliomas across real-world clinical settings. The rate of development of targeted treatments and biomarkers has led to increased demand for rapid results in the clinical diagnostic laboratory. This system is easily integrated into pathology laboratories, facilitating fast turnaround time of IDH1-2 results to clinicians.

Sensitivity studies demonstrated a limit of detection of 2.5-5% variant allele frequency, even at DNA inputs below the manufacturer's recommended threshold. Overall, the assay is an effective and accurate method for rapid determination of IDH1/2 mutational status.

With advancements in molecular diagnostics and precision therapy, IDH inhibitors such as ivosidenib, vorasidenib and enasidenib are now mainstay in management of patients with a susceptible mutation. The Idyllaâ„¢ IDH1-2 Mutation Assay Kit (RUO) is a fully automated qPCR assay for the qualitative detection of 15 common mutations in IDH1 (R132C/H/G/S/L) and IDH2 (R140Q/L/G/W, R172K/M/G/W/S) at codon level. The Idyllaâ„¢ IDH1-2 Mutation Assay Kit demonstrates a high concordance with established reference methods across a range of different specimen types.

"The IDH1/IDH2 cartridge-based assay for the Idylla system allows ultra-rapid, sensitive, and robust screening for recurrent mutations at residues R132 in IDH1 and R140 or R172 in IDH2. The system provides reliable analysis of both extracted and pre- extraction tumor tissue from numerous sources beyond FFPE, including direct blood and bone marrow samples. It markedly simplifies the workflows in the lab and enables rapid treatment decisions."

"Biocartis Group NV...announces the launch of the Idylla™ IDH1-2 Mutation Assay Kit (RUO)1 among selected customers. The assay is the first test developed with the new Idylla™ FLEX technology that separates the generic components of an Idylla™ test from the test-specific components. The Idylla™ IDH1-2 Mutation Assay Kit (RUO) will become globally available to customers during the second half of 2023."