What SensID does

SensID GmbH is a German manufacturer of clinical genomics reference materials and quality controls for molecular diagnostics, founded in 2015 in Rostock, Germany. The company designs and produces human-origin reference materials ("human-tech" samples) across four core product categories: gDNA, cfDNA/ctDNA, plasma (both DNA-free and with cfDNA/ctDNA), and FFPE reference standards. Products are characterized for clinically relevant alterations including point mutations, insertions, deletions, amplifications, and translocations at defined allele frequencies, with proprietary nucleosome-bound ctDNA (n-ctDNA) for MRD-sensitive NGS workflows. Manufacturing operates under DIN EN ISO 13485:2016 (TÜV-certified), with metrologically traceable characterization using SI-traceable digital PCR (QIAGEN QIAcuity), NIST-traceable UV-Vis spectrophotometry, and Agilent fragment analysis. The portfolio spans 33+ oncology genes across SKU lines including EGFR-Multiplex, 5-Gene-Multiplex (AKT1/BRAF/ERBB2/KRAS/PIK3CA), ESR1, PIK3CA, AR-LBD, DPYD, FGFR3, MSI/MSS FFPE, and the PanCancer cfDNA Reference Standard covering 80 synthetic standards.

The business operates on a quote-based direct sales model through its e-commerce website, supplemented by an exclusive distribution agreement with TATAA Biocenter AB covering Sweden, Denmark, Norway, Finland, the Czech Republic, and Slovakia, plus custom/tailored reference material development services with typical MOQs around 90 vials and 8–12 week lead times. Key customers and integration partners include QIAGEN (therascreen PIK3CA RGQ PCR Kit controls), Biocartis (Idylla MSI FFPE Reference Set CE-IVD), and Promega (OncoMate MSI Dx validation), alongside clinical and academic collaborators such as SAGA Diagnostics, Noscendo, the University of Greifswald, and Rottendorf Pharma. SensID was acquired by Microbiologics in November 2024, becoming the US-based QC provider's first international location and expanding its presence into European molecular diagnostics and oncology reference materials.

Name

SensID

Legal name

SensID GmbH

Website

https://sens-id.com

Company type

Private

Founded year

2015

Operating status

Acquired

Headcount range

1–10 employees

Short description

SensID GmbH, a German manufacturer founded in 2015, designs and produces clinical-grade reference materials and quality controls for molecular diagnostics, serving diagnostic kit manufacturers, clinical laboratories, and precision oncology researchers across global markets.

Ownership category

akta.pro rank

Product category

Clinical Genomics Reference Materials

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

akta.pro secondary industry

Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

• Molecular diagnostic controls
• Clinical reference materials
• DNA quality controls
• CfDNA reference standards
• FFPE reference standards

Headquarters

HQ city

Rostock

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Supply Chain, Infrastructure, Marketing or Sales

Revenue model

1. Reference Materials & Quality Controls Sales: Sale of reference materials and quality control products including gDNA, cfDNA/ctDNA, plasma, and FFPE reference standards. Products sold directly through website and via distribution partners. Custom/tailored product manufacturing available on project basis.
2. Custom Product Development: Tailor-made products developed for specific customer needs including custom allele frequencies, mutations, and plasma-based workflow controls. Minimum order quantities typically around 90 vials for custom projects. Lead times of 8-12 weeks depending on project complexity.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

SensID GmbH designs and manufactures clinical genomics reference materials and quality controls for molecular diagnostics under ISO 13485 conditions. Its portfolio includes human-origin "human-tech" gDNA, cfDNA/ctDNA, plasma (DNA-free and with cfDNA), and FFPE reference standards characterized with metrologically traceable digital PCR and WGS data. Products serve as commutable controls for assay validation, IVDR/FDA compliance, accreditation preparation, and companion diagnostic kit development across NGS, qPCR, and dPCR platforms.

Product overview

SensID GmbH is a German manufacturer specializing in clinical genomics reference materials and quality controls for molecular diagnostics. The company offers a comprehensive portfolio of human-origin reference materials designed to be indistinguishable from patient samples ('human-tech' approach), including gDNA, cfDNA/ctDNA, plasma products, and FFPE reference standards. Products are characterized for mutations including point mutations, insertions, deletions, amplifications, and translocations at defined allelic frequencies. Key product lines include EGFR-Multiplex and 5-Gene-Multiplex cfDNA reference materials for liquid biopsy assays, DPYD pharmacogenomics controls, MSI/MSS FFPE reference sets (including CE-IVD marked Idylla™ products), ESR1 and PIK3CA reference sets for breast cancer diagnostics, and the novel PanCancer cfDNA Reference Standard covering 33 genes with multiple alteration classes. The company also provides custom/tailored reference material manufacturing services and operates under ISO 13485:2016 certification. SensID was acquired by Microbiologics in 2024, expanding its global presence in oncology diagnostics and precision medicine quality solutions.

Differentiator

Problem solved

Functional benefit

Products and services

• gDNA (Genomic DNA) Reference Materials Highly characterized human genomic DNA (gDNA) from cell lines (GM24385/Ashkenazim Son) with publicly available Whole Genome Sequencing data, for NGS workflows, sequencing protocol validation, DNA instrument calibration, and NGS pipeline performance analysis.
• cfDNA / ctDNA (Cell-Free/Tumor DNA) Reference Materials Highly characterized human cell-free DNA (cfDNA) and circulating tumor DNA (ctDNA) from cell lines, manufactured for liquid biopsy assays, with specific mutations at defined allelic frequencies for NGS and digital PCR applications.
• Plasma (human-tech) DNA-free Human recreated DNA-free plasma containing human serum proteins at common plasma concentrations, electrolytes, and EDTA (complying with ICSH and CLSI recommendations); used as no-template control or spike-in matrix for liquid biopsy workflows.
• Plasma (human-tech) + cfDNA / ctDNA Plasma (human-tech) combined with cfDNA at defined concentrations, providing a comprehensive liquid biopsy workflow control that pairs the DNA-free plasma matrix with characterized cfDNA.
• FFPE Reference Standards Formalin-fixed paraffin-embedded (FFPE) reference standards, cell-line derived, including Ashkenazim Son wildtype control and tailored FFPE standards, used as full-workflow controls in diagnostic laboratories and R&D departments.
• Idylla MSI FFPE Reference Set [CE-IVD] CE-IVD marked commutable reference material for the Biocartis Idylla MSI Assay, covering seven MSI loci (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, SULF2), with MSI-H and MSS controls for automated Idylla platform workflow monitoring.
• MSI/MSS FFPE Reference Set [RUO] Research-use-only reference material covering MSI loci across multiple assay systems (Biocartis Panel, NCI Panel, Promega Panel including BAT25, BAT26, MONO-27, NR-21, Penta C, Penta D, NR-24), 100% cell-line based with ddPCR quantification.
• EGFR-Multiplex cfDNA Reference Products Multi-mutation EGFR reference materials with 8 clinically relevant mutations (T790M, G719S, L858R, L861Q, E746_A750delELREA, V769_D770insASV, S752_I759delSPANKEI, S768I) at 0.1%, 1%, and 5% allelic frequencies; designed for liquid biopsy assays and EGFR diagnostic kit validation.
• 5-Gene-Multiplex cfDNA Reference Products Multiplex reference material covering 5 cancer genes (AKT1/BRAF/ERBB2/KRAS/PIK3CA) with 8 mutations at 0.1%, 1%, and 5% allele frequencies; includes PIK3CA mutations relevant to PIQRAY (alpelisib) companion diagnostics.
• DPYD Multiplex Set gDNA Pharmacogenetics reference material for dihydropyrimidine dehydrogenase (DPYD) testing, covering variants recommended by EMA, AMP, and FDA for pre-treatment screening of patients receiving 5-fluorouracil chemotherapy; includes 3 vials at 0%, 50%, and 100% allele frequency.
• FGFR3 FFPE Reference Set FFPE reference set with FGFR3 alterations, including DNA and RNA variants such as FGFR3-TACC3 and FGFR3-BAIAP2L1 fusions, designed to support companion diagnostic (CDx) and laboratory-developed test (LDT) development for FGFR3-related bladder cancer biomarkers.
• AR-LBD Reference Set Quality control material for androgen receptor ligand-binding domain (AR-LBD) mutations in cfDNA, covering clinically relevant variants (L702H, H875Y, F877L, T878A, W742C, V716M) for metastatic castration-resistant prostate cancer (mCRPC) testing.
• ESR1 Reference Set (1% AF cfDNA) First-in-market ESR1 mutations reference set for cfDNA mutation detection, covering 9 clinically relevant ESR1 mutations (L536H, Y537C, L536P, Y537S, L536R, D538G, E380Q, S463P, Y537N) at 1% allele frequency; designed for hormone receptor-positive breast cancer testing.
• ESR1 & PIK3CA Reference Set (1% AF cfDNA) Combined quality control material covering clinically relevant mutations in both ESR1 and PIK3CA genes for breast cancer diagnostics and PI3K inhibitor therapy selection.
• Nucleosome ctDNA (n-ctDNA) Human nucleosomal circulating tumor DNA (n-ctDNA) with exceptionally low mutational background noise and a nucleosome-driven fragmentation profile mimicking natural cfDNA characteristics; designed for highly sensitive NGS workflows and minimal residual disease (MRD) applications.
• PanCancer cfDNA Reference Standard Tumor-derived cfDNA reference material containing 80 synthetic reference standards across 33 genes with SNVs, indels, CNVs, and gene fusions; single-vial multiplex positive control for precision oncology liquid biopsy assay development and validation.
• cfDNA in Plasma for Metagenomics Pathogen control material for metagenomics diagnostics, containing quantified sequences of Candida orthopsilosis, Legionella sainthelensis, Varicella zoster virus, and Epstein Barr Virus (EBV), enabling rapid identification of thousands of microbes via NGS and PCR platforms for sepsis and bloodstream infection diagnostics.
• Custom/Tailored Reference Materials Service Custom reference material design and manufacturing service enabling customers to request tailored products with specific mutations, allele frequencies, concentrations, and formats; includes OEM options for kit-integrated controls and third-party controls for customer labs, with typical minimum order quantities of ~90 vials and 8-12 week lead times.

Quantifiable outcome

• Products stable for 24 months from manufacture date
• +2 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability1 record

Feature4 records

Partnerships

Seven partnerships are on record, tiered flagship, minor and core.

• MicrobiologicsflagshipOthers · 6 November 2024Microbiologics acquired SensID in November 2024, expanding its expertise in diagnostic quality controls into molecular diagnostics and oncology. This acquisition marks Microbiologics' first location outside the United States. SensID continues operations without disruption to ongoing partnerships.
• NoscendominorStrategic or Co-development Partner · 14 October 2020Combined forces to develop contamination-free reference material with known human DNA quantity and virus status for clinical system validation in sepsis diagnostics. Reference material developed by SensID and tested by Noscendo to be positive for standard microbial DNA and completely free of contaminating microbial DNA.
• SAGA Diagnostics ABcoreStrategic or Co-development Partner · 15 July 2020Collaboration to develop Ultra-Low Allelic Frequency (AF) controls for cancer mutations. SAGA Diagnostics is a cancer genomics company focused on precision oncology and ultrasensitive liquid biopsy monitoring. The partnership addresses growing demand for liquid biopsy solutions and accurate testing with approved diagnostic assays.
• Rottendorf PharmaminorStrategic or Co-development Partner · 5 May 2020SensID offered SARS-CoV-2 immunity testing service to Rottendorf Pharma as part of an initiative of the State of Mecklenburg-Western Pomerania to cope with economic consequences of the pandemic. Rottendorf Pharma is a CDMO for solid dosage forms with more than 1100 employees.
• QiagencoreTechnology or Integration · 21 April 2020Developed a set of controls for the FDA-approved and CE-IVD marked therascreen PIK3CA RGQ PCR Kit from Qiagen. The CE-IVD kit was launched in Europe in February 2020 as an aid to identification of activating PIK3CA mutations in advanced breast cancer patients. US IVD Kit approved by FDA in 2019 as companion diagnostic for Novartis drug PIQRAY (alpelisib).
• TATAA Biocenter ABcoreChannel Partner/ Reseller/ Distributor · 14 May 2019Distribution agreement signed May 2019 grants TATAA full access to SensID's continuously growing product portfolio for Molecular Diagnostics. TATAA represents SensID in Sweden, Denmark, Norway, Finland, Czech and Slovak Republics. TATAA is described as a pioneer within the industry and leading provider of high quality molecular analyses.
• University of GreifswaldcoreStrategic or Co-development PartnerMultiple ERDF-funded research collaborations with University of Greifswald: (1) Certified reference materials for molecular diagnostics with proof of concept study, (2) RNA reference materials for NGS analytics for gene fusion detection, (3) Epigenetic methylation profiles development for NGS analysis techniques. Professor Kuss (AG Molekulare Humangenetik) is the key academic collaborator.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Microbiologics: Parent company and direct comp in QC materials for microbiology and molecular diagnostics. Acquired SensID in November 2024; both produce reference materials and quality controls for clinical diagnostics, with SensID extending Microbiologics' portfolio into cfDNA/ctDNA and oncology.
• Qnostics: UK-based manufacturer of molecular QC controls and reference materials for infectious disease and clinical diagnostics. Comparable as a focused reference-material specialist, though with a different primary emphasis on pathogen testing.
• ZeptoMetrix: Specialty QC manufacturer (part of Antylia Scientific) producing molecular controls, infectious disease reference materials, and QC standards for clinical labs. Comparable niche in QC for molecular diagnostic workflows.
• Invivoscribe: Develops and manufactures in vitro diagnostic reagents and reference materials, particularly in hematology/oncology. Comparable as a CE-IVD/FDA-registered reference-materials provider with overlapping clinical genomics customer base.
• Maine Molecular Quality Controls (MMQCI): Specializes in molecular diagnostics QC controls and reference materials for infectious disease, pharmacogenomics (DPYD), and oncology assays. Closely comparable product portfolio to SensID, including IVD-grade quality controls.

Broad incumbents

• Promega Corporation: Broad life-science tools provider whose OncoMate MSI Dx assay integrates with SensID's MSI/MSS FFPE Reference Set. Comparable in offering validated kits with associated reference materials for oncology diagnostics.
• LGC Clinical Diagnostics (SeraCare): Through SeraCare, LGC provides a comprehensive portfolio of reference materials, SeraConaTe plasma, and ctDNA controls for clinical genomics. Comparable to SensID in molecular diagnostics QC but operates at significantly larger global scale.
• Bio-Techne (incl. formerly Horizon Discovery): Major life-science tools provider with a dedicated diagnostics reference-materials business (formerly Horizon Discovery). Offers cell-line-derived reference standards, including cfDNA and FFPE controls, overlapping directly with SensID's gDNA, cfDNA/ctDNA, and FFPE product lines.

Emerging players

• Atila Biosystems: Specialty developer of molecular diagnostic assays and reference standards, including HPV and oncology panels. Comparable as an emerging reference-materials provider with overlapping molecular diagnostics use cases.
• AccuRef Diagnostics: Emerging player offering reference materials and quality controls for clinical genomics and molecular diagnostics, including cfDNA standards. A smaller, more recently established peer addressing overlapping customer use cases.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCdHLwJBSFKn3W6LzfJKKa3A
• LinkedInlinkedin.com/company/sensid-gmbh

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SensID