Biotype Diagnostics
Biotype Diagnostics is a German molecular precision diagnostics company that develops CE-IVD test kits, automated sample preparation systems, and the MODAPLEX bench-top platform for clinical and research laboratories in hemato-oncology, solid tumor profiling, and chimerism monitoring, sold globally through distributors and direct enterprise channels.
- Company typePrivate
- Founded1999
- HeadquartersDresden, Germany
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What Biotype Diagnostics does
Biotype Diagnostics GmbH is a privately held German molecular precision diagnostics company headquartered in Dresden, founded in 1999. The company develops, manufactures, and markets CE-IVD marked and RUO molecular diagnostic test kits, automated sample preparation systems, and bench-top instrumentation for the detection and quantification of RNA and DNA markers. Its products are used primarily by professional clinical and research laboratories in hemato-oncology, molecular profiling of solid tumors, liquid biopsy, chimerism monitoring after stem cell transplantation, tumor diagnostics, and forensic DNA applications.
The product portfolio is anchored by the proprietary MODAPLEX platform — a bench-top system for multiparameter nucleic acid analysis enabling comprehensive multi-biomarker testing in a single workflow — and supported by the IntelliPrep TRIO 240 automated sample preparation system, the Mentype PCR amplification kit family (including AMLplexQS detecting 34 transcript variants of 11 AML gene fusions, and Chimera/DIPscreen for chimerism monitoring), the Droplex tumor diagnostic mutation tests (EGFR, PIK3CA, ESR1), forensic Sampletype i-sep extraction products, and the ChimerisMonitor analysis software. Multiple assays and instruments are CE-IVD certified under EU IVDR.
Biotype operates a hybrid commercial model. CE-IVD kits and consumables are sold through a global network of 14+ regional distribution partners spanning Europe, the Middle East, South Asia, and Latin America. MODAPLEX instruments are sold via direct enterprise sales with mandatory six-month maintenance contracts, and the platform's consumables are restricted to BIOTYPE test kits per the company's general terms. The company also offers contract development, multiplex assay development, and contract manufacturing (CDMO) services to third parties, exemplified by its June 2026 agreement with Urteste S.A. for the Panuri pancreatic cancer urine test. Pricing is not publicly disclosed; all sales are to commercial customers.
Biotype Diagnostics firmographics
Firmographics- Name
- Biotype Diagnostics
- Legal name
- BIOTYPE GmbH
- Website
- https://biotype.de
- Company type
- Private
- Founded year
- 1999
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Biotype Diagnostics is a German molecular precision diagnostics company that develops CE-IVD test kits, automated sample preparation systems, and the MODAPLEX bench-top platform for clinical and research laboratories in hemato-oncology, solid tumor profiling, and chimerism monitoring, sold globally through distributors and direct enterprise channels.
- Ownership category
- akta.pro rank
Where Biotype Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Dresden
- HQ country
- Germany
- HQ region
- Europe
Offices1 record
Markets served
Biotype Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure
Revenue model
- IVD Products and Consumables: Sale of molecular diagnostic test kits including CE-IVD clinical diagnostics products and RUO (Research Use Only) assays. Consumables and test kits required for MODAPLEX system operation. Transaction-based sales model for individual products.
- MODAPLEX Instrument Systems: Sale of MODAPLEX bench-top molecular diagnostics systems with mandatory 6-month maintenance contracts. Hardware plus recurring service revenue model.
- Contract Manufacturing Services: CDMO services for third-party biotech companies including test production for clinical studies (e.g., Panuri test for Urteste S.A.).
- Custom Solutions and Development Services: Contract development, multiplex assay development, and custom manufacturing services for partners requiring tailored diagnostic solutions.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | CE-IVD Products for Clinical Diagnostics |
| One time/ perpetual license | Pay-as-you-go | RUO Products for Research |
| Subscription | Multi-year contract | MODAPLEX System with Maintenance Contract |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels4 records
Biotype Diagnostics product offering
Product offeringCore offering
BIOTYPE develops, manufactures, and markets molecular diagnostic kits and instruments for the detection and quantification of RNA and DNA markers used in clinical diagnostics and translational research. Its portfolio centers on the proprietary MODAPLEX bench-top platform for multi-biomarker testing, the IntelliPrep TRIO 240 automated sample preparation system, CE-IVD and RUO PCR amplification kits (Mentype, Droplex) for hemato-oncology, solid tumor profiling, liquid biopsy, and chimerism monitoring, the ChimerisMonitor software, and contract development and manufacturing (CDMO) services for third-party diagnostics.
Product overview
BIOTYPE offers a comprehensive molecular precision diagnostics portfolio organized around a core platform plus specialized assay ecosystem. The flagship MODAPLEX Platform serves as the bench-top system for molecular multi-marker testing, with dedicated assay kits for solid tumor molecular profiling (POLE/POLD1, MSI, FGFR3, FGFR Gene Fusion, NRAS mutations). Supporting the platform is the IntelliPrep TRIO 240 Sample Preparation System with extraction kits for FFPE DNA/RNA, blood genomic DNA, and cfDNA. The hemato-oncology portfolio includes Mentype AMLplexQS (34 transcripts of 11 gene fusions) and Mentype AMLplus mutation analysis kits, alongside ChimerisMonitor software for automated analysis. Chimerism monitoring products (Mentype Chimera, DIPscreen, DIPquant) serve post-transplant monitoring needs. Liquid biopsy research tools include Mentype DigitalScreen and DigitalQuant. The forensic portfolio features Mentype Nonaplex I and Sampletype i-sep differential lysis products. Tumor diagnostics include Droplex EGFR, PIK3CA, and ESR1 mutation tests. Many products carry CE-IVD marking for clinical use, with RUO variants for research applications.
Differentiator
Problem solved
Functional benefit
Brands
- MODAPLEX: Proprietary bench-top platform for molecular multi-marker testing and multiparameter nucleic acid analysis.
- Mentype
- Droplex
- IntelliPrep
- Sampletype i-sep
Products and services
- MODAPLEX Platform Bench-top system for molecular multi-marker testing that enables comprehensive biomarker analysis in one integrated workflow for clinical laboratories running CE-IVD assays on solid tumors, hemato-oncology, and chimerism monitoring.
- MODAPLEX POLE/POLD1 Mutation Analysis Kit CE-IVD assay kit that detects POLE and POLD1 gene mutations associated with colorectal and endometrial cancers, run on the MODAPLEX platform.
- MODAPLEX MSI Analysis Kit CE-IVD assay for microsatellite instability (MSI) assessment of tumor instability patterns in colorectal cancer diagnostics, run on the MODAPLEX platform.
- MODAPLEX Copy Number High Analysis Kit CE-IVD assay for detecting gene amplification events and copy number variation in solid tumors using the MODAPLEX platform.
- MODAPLEX FGFR3 Mutation Kit CE-IVD assay for rapid detection of clinically relevant somatic FGFR3 mutations in bladder cancer and other solid tumors on the MODAPLEX platform.
- MODAPLEX FGFR Gene Fusion Kit CE-IVD assay for comprehensive detection of relevant FGFR2 and FGFR3 gene fusions, completed within 4.5 hours on the MODAPLEX platform.
- MODAPLEX NRAS Mutation Kit CE-IVD assay for the detection of NRAS gene variants in cancer diagnostics, run on the MODAPLEX platform.
- QPCR POLE Mutation Analysis Kit Research Use Only qPCR-based detection kit for 6 POLE mutations in solid tumors for translational and clinical research applications.
- IntelliPrep TRIO 240 Sample Preparation System 4-in-1 walk-away automated platform for up to 24 samples performing extraction, quantification, normalization, and PCR plate setup in a single uninterrupted run, compatible with FFPE tissue, whole blood, plasma, and more.
- IntelliPrep FFPE DNA Extraction Kit CE-IVD xylene-free, fully automated DNA purification kit from formalin-fixed, paraffin-embedded (FFPE) tissue for consistent DNA quality in oncology and pathology workflows.
- IntelliPrep FFPE RNA Extraction Kit CE-IVD automated RNA isolation kit from FFPE tissue with integrated deparaffinization, optimized for sensitive downstream applications such as gene expression analysis.
- IntelliPrep Blood Genomic DNA Extraction Kit CE-IVD high-yield extraction kit for genomic DNA from whole blood or buffy coat, suited to clinical genetics, pharmacogenomics, and population studies.
- IntelliPrep cfDNA Extraction Kit CE-IVD automated purification kit for circulating cell-free DNA from up to 5 mL plasma, preserving the short, fragmented cfDNA fragments critical for liquid biopsy applications.
- Mentype AMLplexQS PCR Amplification Kit CE-IVD PCR amplification kit that detects 34 transcript variants of 11 gene fusions associated with acute myeloid leukemia (AML) for clinical diagnostics.
- Mentype AMLplus Mutation Analysis Kit CE-IVD mutation analysis kit for investigating AML-associated mutations in hematological malignancies, used in combination with AMLplexQS for unified AML screening workflows.
- Mentype Chimera PCR Amplification Kit CE-IVD chimerism analysis kit based on 12 STR markers plus Amelogenin for monitoring engraftment after allogeneic stem cell transplantation.
- Mentype DIPscreen PCR Amplification Kit CE-IVD chimerism analysis kit based on 33 INDEL markers plus Amelogenin for engraftment monitoring after stem cell transplantation.
- Mentype DIPquant CE-IVD quantitative chimerism analysis kit for precise quantification of donor cell engraftment after stem cell transplantation.
- Mentype DigitalScreen Research Use Only digital PCR-based screening assay for liquid biopsy applications in oncology research.
- Mentype DigitalQuant Research Use Only digital PCR-based quantitative assay for liquid biopsy applications in oncology research.
- Mentype Nonaplex I PCR Amplification Kit Forensic PCR amplification kit for human DNA profile determination using 8 highly polymorphic STR markers plus Amelogenin.
- Sampletype i-sep SQ-MB Forensic consumable for DNA extraction from sexual assault evidence samples using the Sampletype i-sep magnetic bead workflow.
- Sampletype i-sep DL-MB Forensic consumable for differential lysis separation of sperm and epithelial cells from gynecological swabs in forensic DNA analysis.
- Sampletype i-sep MB Forensic consumable for standard DNA extraction from forensic samples with 90% lysis efficiency for high DNA yields.
- Matrix Standard BT5 multi CE-IVD spectral alignment standard reagent for genetic analyzers used with BIOTYPE hemato-oncology PCR kits.
- ChimerisMonitor CE-IVD software application that supports automated chimerism analysis after running Mentype Chimera, Mentype DIPscreen, or Mentype DIPquant assays.
- Droplex EGFR Mutation Test v2 CE-IVD digital-PCR-based test that detects 107 defined mutations in the epidermal growth factor receptor (EGFR) gene to support targeted therapy selection in lung cancer.
- Droplex PIK3CA Mutation Test CE-IVD digital-PCR-based test that detects 11 defined mutations in the catalytic alpha subunit of the PI3K gene (PIK3CA) for breast cancer diagnostics.
- Droplex ESR1 Mutation Test CE-IVD digital-PCR-based test that detects 16 defined mutations in the ligand-binding domain of the ESR1 gene for breast cancer therapy monitoring.
- Contract Development and Manufacturing (CDMO) Services Contract development, multiplex assay development, custom packaging, and contract manufacturing services for third-party biotech and medtech partners requiring tailored molecular diagnostic solutions, including clinical study kit supply such as the Panuri test for Urteste S.A.
Quantifiable outcome
- 89% sensitivity and 75% specificity demonstrated in Panuri test preliminary data
- +2 more outcomes
Companies that use Biotype Diagnostics
Customer profileNamed customers1 record
Segments5 records
Ideal customer profiles3 records
Biotype Diagnostics technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Biotype Diagnostics partnerships and signals
Strategic signalPartnerships
16 partnerships are on record, tiered core, minor and regional.
- Urteste S.A.coreBiotype serves as German CDMO (Contract Development and Manufacturing Organization) for Urteste S.A., a Polish medical technology company listed on Warsaw Stock Exchange. Biotype produces the Panuri urine-based diagnostic test for pancreatic cancer detection. The multicenter clinical study involves 550 participants across 30 centers in Poland, Hungary, and Italy with interim results expected Q4 2026. Positive results could advance the test toward European IVD certification.
- SaxoCell e.V.minorBIOTYPE joined SaxoCell e.V., a networking organization for Saxon cell biology and biotech stakeholders. BIOTYPE participated in SaxoCell Conference 2026 in Dresden.
- P. Zafiropoulos S.A.regionalNew distribution partnership in Greece and Cyprus announced March 2026 for BIOTYPE molecular diagnostic products.
- PlexBioregionalDistribution partnership for IntelliPrep TRIO 240 Sample Preparation System in Germany and Austria. PlexBio serves as regional distributor for BIOTYPE's automated sample preparation equipment.
- ELTA 90 Medical Science d.o.o.regionalRegional distribution partner covering Bosnia and Herzegovina, Serbia, and Montenegro.
- DimunaregionalRegional distribution partner covering Estonia, Lithuania, and Latvia.
- Astra Formedic - Gruppo A.De MoriregionalRegional distribution partner for Italy.
- RibiconregionalRegional distribution partner covering Saudi Arabia, UAE, Qatar, Bahrain, Kuwait, and Oman (GCC states).
- Biosistemi grupa d.o.o.regionalRegional distribution partner for Croatia.
- 3i Molecular SolutionsregionalRegional distribution partner for India.
- Kemisk Specialities Private LimitedregionalRegional distribution partner for Pakistan.
- PentaGen s.r.o.regionalRegional distribution partner covering Poland, Slovakia, Czech Republic, and Hungary.
- Diagnostica LongwoodregionalRegional distribution partner covering Portugal, Spain, and Latin America.
- Bio Supply DevelopmentregionalRegional distribution partner for Romania.
- RUWAG Handels AGregionalRegional distribution partner for Switzerland.
- ATQ BiyoteknolojiregionalRegional distribution partner for Turkey.
Scale indicators3 records
Recent moves5 records
Expansion highlights5 records
Biotype Diagnostics competitors and assessment
Company assessmentDirect peers
- Seegene: Seegene is a Korean molecular diagnostics company specializing in multiplex PCR technologies with proprietary syndrome/pathogen panels. Like BIOTYPE's MODAPLEX, Seegene's platforms enable simultaneous detection of multiple targets in a single reaction, making it a directly comparable multiplex-PCR peer.
- Diagenode: Diagenode is a Belgium-based life sciences company providing DNA/RNA extraction kits, epigenetics assays, and molecular diagnostics products. It overlaps directly with BIOTYPE in nucleic acid extraction consumables and molecular assay development for clinical and research customers.
- Molzym: Molzym is a German-based molecular diagnostics company focused on automated DNA extraction and pathogen detection kits, including CE-IVD products for sepsis and infection diagnostics. It is a closely comparable European peer in molecular sample prep and IVD kit manufacturing.
- Abacus Diagnostica: Abacus Diagnostica is a Finnish molecular diagnostics company specializing in rapid PCR-based IVD kits for infectious disease and HLA typing. As a smaller European IVD manufacturer with comparable product structure, it is a direct peer in bench-top molecular IVD commercialization.
Broad incumbents
- Qiagen: Qiagen is a global molecular diagnostics and sample technologies leader headquartered in Germany, offering PCR-based IVD kits, instruments, and consumables across oncology and infectious disease. It overlaps with BIOTYPE in multiplex PCR assays, nucleic acid extraction, and CE-IVD oncology panels, though at substantially larger scale and broader menu.
- Bio-Techne: Bio-Techne provides molecular biology reagents, exosome diagnostics and assay kits used in translational and clinical research. Its reagents and assays serve similar customers as BIOTYPE (clinical and research labs), and its diagnostics division competes in adjacent molecular biomarker segments.
- Cepheid (Danaher): Cepheid, owned by Danaher, markets the GeneXpert bench-top molecular diagnostics system with a broad IVD test menu across infectious disease, oncology and genetics. Its bench-top instrument-plus-cartridge model is structurally analogous to BIOTYPE's MODAPLEX system-plus-consumables approach, although at much larger global scale.
- Hologic: Hologic is a broad diagnostics incumbent with significant molecular diagnostics franchises (e.g., Panther system, NovaQuant) covering women's health, oncology and infectious disease. Its molecular diagnostics menu and global installed base overlap with BIOTYPE's oncology and liquid biopsy focus, although Hologic operates at far greater scale across multiple clinical verticals.
Market position
Strengths1 record
Weaknesses1 record
Competitive moat4 records
Key risks2 records
Key highlights6 records
Customer concentration
Biotype Diagnostics social profiles
Digital presenceBiotype Diagnostics compliance and trust
Trust signalCompliance1 record
Biotype Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Biotype Diagnostics leadership team
Management profileNumber of profiles
Profiles2 records
Biotype Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Biotype Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Biotype Diagnostics
What does Biotype Diagnostics do?
BIOTYPE develops, manufactures, and markets molecular diagnostic kits and instruments for the detection and quantification of RNA and DNA markers used in clinical diagnostics and translational research. Its portfolio centers on the proprietary MODAPLEX bench-top platform for multi-biomarker testing, the IntelliPrep TRIO 240 automated sample preparation system, CE-IVD and RUO PCR amplification kits (Mentype, Droplex) for hemato-oncology, solid tumor profiling, liquid biopsy, and chimerism monitoring, the ChimerisMonitor software, and contract development and manufacturing (CDMO) services for third-party diagnostics.
Is Biotype Diagnostics a public or private company?
Biotype Diagnostics is a private company. It is classified as family owned and is currently operating.
When was Biotype Diagnostics founded?
Biotype Diagnostics was founded in 1999. It employs 51 to 100 people.
Where is Biotype Diagnostics based?
Biotype Diagnostics is headquartered in Dresden, Germany, in the Europe region.
How does Biotype Diagnostics make money?
Four revenue lines are on record. IVD Products and Consumables are the primary driver. The others are MODAPLEX Instrument Systems, contract Manufacturing Services and custom Solutions and Development Services.
Who are Biotype Diagnostics's main competitors?
Direct peers on record are Seegene, Diagenode, Molzym and Abacus Diagnostica. Broad incumbents are Qiagen, Bio-Techne, Cepheid (Danaher) and Hologic.
Does Biotype Diagnostics have an API?
No public API is recorded for Biotype Diagnostics.