Molecular Diagnostic Assays

Solutions for molecular precision diagnostics

BIOTYPE provides a robust portfolio of molecular cancer diagnostics to support hemato-oncology, liquid biopsy, and molecular profiling of solid tumors. The portfolio comprises IVD assays for clinical diagnostics, RUO assays for translational and clinical research, and a benchtop system for automated molecular profiling.

Professional laboratories use the molecular test systems to diagnose cancer patients accurately, determine the best treatment option, and timely identify actionable biomarkers for molecular-guided therapy.

Molecular Profiling of Solid Tumors

MODAPLEX FGFR3 Mutation Kit

Fast detection of actionable somatic FGFR3 mutations

Molecular Profiling of Solid Tumors

MODAPLEX FGFR Gene Fusion Kit

Comprehensive detection of relevant FGFR2 and FGFR3 Gene Fusions in 4.5 hours

Custom Solutions

Multiplex Assay Development

Customized multiplex assays for PCR and MODAPLEX platforms

DIP Positive Control DPC

Qualitative Positive Control for DIP Polymorphisms

Molecular Profiling of Solid Tumors

QPCR POLE Mutation Analysis Kit

qPCR based detection of 6 POLE mutations

Tumor Diagnostics

Droplex ESR1 Mutation Test

Detection of 16 defined mutations within the ligand-binding domain of the ESR1-gene

Tumor Diagnostics

Droplex PIK3CA Mutation Test

Detection of the 11 defined mutations within the catalytic a-subunit of the PI3K gene

Tumor Diagnostics

Droplex cMET Exon 14 Skipping Mutation Test

Detection of the Exon 14 Skipping on RNA level

Tumor Diagnostics

Droplex EGFR Mutation Test v2

Detection of the 107 defined mutations within the epidermal growth factor receptor (EGFR) gene

Tumor Diagnostics

Droplex BRAF Mutation Test v2

Detection of the 2 defined mutations within the proto-oncogene BRAF

Tumor Diagnostics

Droplex KRAS Mutation Test v2

Detection of the 28 defined mutations within the KRAS oncogene

MODAPLEX Platform

MODAPLEX Instrument

Benchtop system for molecular multi-marker testing

Tumor Diagnostics

Droplex POLE Mutation Test

Detection of the 6 defined mutations within the POLE gene

Hemato-Oncology

Mentype® AMLplexQS PCR Amplification Kit

Detection of 34 transcript variants of 11 gene fusions

Forensic Applications

Mentype® Nonaplex I PCR Amplification Kit

Human identification with 8 highly polymorphic STR-markers + Amelogenin

Forensic Applications

Sampletype i-sep® DL-MB

Differential lysis of sperm and epithelial cells of gynecological swabs

Forensic Applications

Sampletype i-sep® SQ-MB

DNA extraction of forensic samples

Forensic Applications

Sampletype i-sep® MB

Highest DNA yields with 90 % lysis efficiency

Hemato-Oncology

Matrix Standard BT5 multi

The matrix for your Genetic Analyzer

Chimerism Monitoring

ChimerisMonitor

Software supporting automated chimerism analysis after application of Mentype® Chimera®, Mentype® DIPscreen or Mentype® DIPquant

Mentype® DigitalQuant

Quantitative engraftment detection using 59 INDEL assays for digital PCR

Mentype® DigitalScreen

Screening for 30 INDEL markers with digital dropletTM PCR

Chimerism Monitoring

Mentype® DIPquant

Quantitative engraftment detection using 56 INDEL assays for qPCR

Chimerism Monitoring

Mentype® DIPscreen

Chimerism analysis based on 33 INDEL markers + Amelogenin

Chimerism Monitoring

Mentype® Chimera® PCR Amplification Kit

Chimerism analysis based on 12 STR markers + Amelogenin

Molecular Profiling of Solid Tumors

MODAPLEX NRAS Mutation Kit

Detect 15 NRAS mutations with high sensitivity in 4 hours

Molecular Profiling of Solid Tumors

MODAPLEX Copy Number High Analysis Kit

Copy Number variation testing using multiple target and reference regions

Molecular Profiling of Solid Tumors

MODAPLEX MSI Analysis Kit

Microsatellite instability testing using 5 mononucleotide und 2 dinucleotide repeat markers

Molecular Profiling of Solid Tumors

MODAPLEX POLE/POLD1 Mutation Analysis Kit

Analysis of 19 mutations within the POLE and POLD1 genes