ipsogen IDH1 RGQ PCR Kit

• Clinically validated IVD for TIBSOVO (ivosidenib) in newly diagnosed AML
• Reliable detection of 5 mutations in the IDH1 gene
• Ready-to-use system with simple workflow and next-day results
• Automated analysis of PCR data using Rotor-Gene AssayManager v2.1 software or higher

The ipsogen IDH1 RGQ PCR Kit is a real-time, qualitative in vitro diagnostic test for detection of single nucleotide variants (SNVs) encoding five IDH1 mutations (R132C, R132H, R132G, R132S and R132L). The assay uses genomic DNA extracted from fresh or frozen human whole blood or bone marrow aspirate specimens collected in K2-EDTA tubes from patients with newly diagnosed acute myeloid leukemia (AML).

The ipsogen IDH1 RGQ PCR Kit is a clinically validated IVD PCR test intended to aid in the identification of newly diagnosed AML patients who may be eligible for treatment with TIBSOVO (ivosidenib) based on an IDH1 mutation detected result.

Clinical performance: Diagnostic sensitivity and specificity¹

The ipsogen IDH1 RGQ PCR Kit (IDH1 Kit) was compared with a next-generation sequencing (NGS) reference test, the Archer VariantPlex Core Myeloid panel (validated by ICON) in newly diagnosed AML patients (Table 1). The overall diagnostic sensitivity was 98.48% (Clopper-Pearson (Exact) Binomial 95% confidence interval (CI): (91.84%, 99.96%) and the diagnostic specificity was 100% (95% CI: (96.11%, 100%) (Table 2). 

The analysis of clinical performance was also performed on a per-mutation basis as presented in Table 3 and Table 4.

Clinical performance: Clinical utility/efficacy of the ipsogen IDH1 RGQ PCR Kit with TIBSOVO treatment in newly diagnosed AML¹

A clinical bridging study demonstrated that the positive percent agreement (PPA) and negative percent agreement (NPA) for the device in question versus the Abbott Realtime IDH1 device (used for enrolment in the AG120-C-009 study) met the concordance requirements of PPA and NPA ≥95%. Furthermore, in newly diagnosed AML patients the clinical efficacy in terms of event free survival (EFS) and other clinical endpoints were in line with the summary results in the drug AG120-C-009 study report.

1.       ipsogen IDH1 RGQ PCR Kit Instructions for Use, Rev.01. April 2025.

The ipsogen IDH1 RGQ PCR Kit is based on the detection by selective amplification of five IDH1 mutations in genomic DNA (gDNA) extracted from whole blood or bone marrow aspirate (BMA) specimens. The assay utilizes the real-time PCR oligonucleotide hydrolysis reaction principle with TaqMan probes. Allele-specific technology allows accurate and highly reproducible detection of target IDH1 mutations, based on the use of specific forward and reverse primer and probe sets.

Result reporting is fully automated. If both the run controls and the sample results are valid, and assay target amplification is below the pre-determined cutoff threshold, the report will display the IDH1 mutation(s) detected in each sample.

The simple and straightforward testing workflow begins with manual DNA extraction from either fresh or frozen human whole blood or bone marrow aspirate specimens collected in K2-EDTA tubes using the QIAamp DSP DNA Blood Mini Kit. This is followed by sensitive real-time PCR on the Rotor-Gene Q MDx 5plex HRM instrument. Rotor-Gene AssayManager (RGAM) software v2.1 or higher with the Rotor-Gene AssayManager Gamma Plug-in and the ipsogen IDH1 RGQ PCR Kit Assay Profile rapidly and accurately determine mutations. The results are reported, informing the system operator if one or more of the five mutations detected by the kit are present. The assay can be completed in ~8 hours, providing next-day results.

The ipsogen IDH1 RGQ PCR Kit enables qualitative detection of single nucleotide variants (SNVs) encoding five IDH1 mutations (R132C, R132H, R132G, R132S and R132L) for in vitro diagnostic use. The kit is intended to discriminate between IDH1 mutation-negative (wild-type) and IDH1 mutation-positive patient DNA.

The ipsogen IDH1 RGQ PCR Kit is a clinically validated IVD PCR test intended to aid in the identification of newly diagnosed AML patients for treatment with TIBSOVO (ivosidenib).