Analysis Kit

For improved decision-making:
A comprehensive POLE/POLD1 mutation panel


  • Analyze 19 POLE and POLD1 mutations required for the risk classification of endometrial cancer
  • Low DNA input – 4 ng per sample
  • Benefit from an efficient workflow using a kit-specific data analysis software requiring no additional bioinformatics
  • Verified with colorectal and endometrial cancer samples

Detection and differentiation of 19 somatic and rare germline mutations in the polymerase epsilon and polymerase delta-1 exonuclease domains is effectively achieved using the MODAPLEX POLE/POLD1 Mutation Analysis Kit. The assay enables researchers to advance promptly in clinical research.

Modaplex POLE/POLD1 Mutation Analysis Kit


Cat. No.   85-10101-0050

POLE EDMs: T278M, P286L, P286H, P286R, S297A, S297F, F367S, V411L(G>C), V411L (G>T), H422N, L424V, P436R, M444K, A456P, S459F, A465V

POLD1 EDMs: D316N, C319Y, S478N

Reactions   1 Multiplex-PCR per sample
Kit content  

All reagents required to perform PCR are part of the MODAPLEX POLE/POLD1 Mutation Analysis Kit

• POLE/POLD1 Primer Mix
• POLE/POLD1 Positive Control
• PCR Buffer 11
• Nuclease-Free Water
• MODAPLEX Polymerase P
• MODAPLEX Calibrator 2

Internal controls   2 (POLE and POLD1 gene)
PCR controls   2 included (PC, NTC)
Sample input   ~ 4 ng gDNA (FFPE)
Sensitivity   Down to 2 %
Turn-around time   ~ 4 h after nucleic acid preparation (including data analysis)
Detection   Qualitative
To be used with   MODAPLEX instrument
Data analysis   MODAPLEX Reporter software


With the Modaplex POLE/POLD1 Mutation Analysis Kit clinical research laboratories have access to results in 3.5 hours after nucleic acid preparation.

Modaplex Workflow

The Modaplex POLE/POLD1 Mutation Analysis Assays is to be used with the Modaplex instrument platform version 1.0 or higher. Thus, the POLE/POLD1 workflow is similar to the workflow of other Biotype Modaplex assays such as MSI Analysis Assay and comprises the same three steps after nucleic acid preparation: PCR set up, Modaplex run, and result interpretation.


MODAPLEX POLE/POLD1 Mutation Analysis Kit Instructions for Use (IFU)

Order Information

Product: MODAPLEX POLE/POLD1 Mutation Analysis Kit
Size 50 reactions
Cat. No. 85-10101-0050
Status RUO*

*RUO – Research Use Only products must be validated by the customer with clinically relevant material for diagnostic purposes.

To order the MODAPLEX POLE/POLD1 Mutation Analysis Kit, please e-mail us at