Cerca Biotech
Cerca Biotech GmbH is a Berlin-based European subsidiary of Shuwen Biotech that markets RT-qPCR-based IVD tests (MammaTyper® for breast cancer subtyping and RNXtract® for FFPE RNA extraction) to clinical pathology laboratories and oncology providers globally through a four-region distributor network.
- Company typePrivate
- Founded2021
- HeadquartersBerlin, Germany
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Cerca Biotech does
Cerca Biotech GmbH is a Berlin-headquartered European subsidiary of Shuwen Biotech, a molecular and point-of-care diagnostics organization based in China. Founded around 2021, the company manufactures and markets in-vitro diagnostic (IVD) products focused on women's health, specifically molecular subtyping of breast cancer. The firm operates with a small team of 1-10 employees.
The company's core offering is MammaTyper®, a standardized RT-qPCR (reverse transcription quantitative polymerase chain reaction) IVD assay that quantifies four key breast cancer biomarkers — ERBB2 (HER2), ESR1 (estrogen receptor), PGR (progesterone receptor), and MKI67 (Ki-67) — to determine molecular subtypes including Luminal A-like, Luminal B-like (HER2 negative), Luminal B-like (HER2 positive), HER2-positive (non-luminal), and triple-negative. The test uses a proprietary 40-ΔΔCq algorithm combined with multiplex control genes to deliver results with documented concordance of 95% for HER2 and 94.7% for ER against IHC/FISH reference standards. A complementary product, RNXtract®, is a magnetic-bead IVD kit for extracting and purifying total RNA from formalin-fixed, paraffin-embedded (FFPE) samples, enabling the upstream sample preparation required for the MammaTyper workflow. The company also offers the MammaTyper Report Generator, a web-based platform accepting data from eight real-time PCR instrument families (Roche LightCycler, Bio-Rad CFX96, Agilent Mx3000P, ThermoFisher, etc.) to calculate molecular subtypes using the proprietary algorithm.
Commercially, Cerca Biotech sells its IVD kits through a four-region distributor network covering Asia Pacific, EMEA, Latin America, and North America, with no direct sales force. Pricing is not publicly disclosed. The company targets clinical pathology laboratories and oncology healthcare providers, addressing pain points around the reproducibility limitations of immunohistochemistry (IHC), accurate HER2-low classification for emerging antibody-drug conjugate therapies, and identification of patients unlikely to benefit from chemotherapy. Products carry CE marking for the European market, and the company operates an ISO 13485 quality management system with active IVDR readiness preparation. Marketing is concentrated on clinical evidence generation — peer-reviewed publications, KOL engagement at St Gallen and SABCS conferences, white papers, and LinkedIn newsletter content — rather than broad promotional spend.
Cerca Biotech firmographics
Firmographics- Name
- Cerca Biotech
- Legal name
- Cerca Biotech GmbH
- Website
- https://cercabiotech.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Cerca Biotech GmbH is a Berlin-based European subsidiary of Shuwen Biotech that markets RT-qPCR-based IVD tests (MammaTyper® for breast cancer subtyping and RNXtract® for FFPE RNA extraction) to clinical pathology laboratories and oncology providers globally through a four-region distributor network.
- Ownership category
- akta.pro rank
Cerca Biotech industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)
- akta.pro secondary industries
- Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk) (HLAAAMAF), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)
Keywords
Where Cerca Biotech is headquartered
LocationHeadquarters
- HQ city
- Berlin
- HQ country
- Germany
- HQ region
- Europe
Offices1 record
Markets served
Cerca Biotech business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations
Revenue model
- MammaTyper® Diagnostic Test Kits: Sale of IVD diagnostic test kits for breast cancer molecular subtyping to clinical laboratories and healthcare institutions through distributor network.
- RNXtract® RNA Extraction Products: Sale of FFPE RNA extraction kits for routine clinical laboratory use.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
Cerca Biotech product offering
Product offeringCore offering
Cerca Biotech manufactures and markets IVD molecular diagnostic products for breast cancer. Its flagship product, MammaTyper®, is an RT-qPCR assay that quantifies four biomarkers (ER, PR, HER2, Ki-67) to determine molecular breast cancer subtypes. The complementary RNXtract® kit extracts RNA from FFPE samples using magnetic beads, and the MammaTyper® Report Generator is a web-based software tool for calculating subtypes from multiple qPCR instruments.
Product overview
Cerca Biotech is a molecular diagnostics company offering two main IVD products. MammaTyper is a standardized RT-qPCR assay for quantifying four breast cancer biomarkers (ER, PR, HER2, Ki-67) to support molecular subtyping and treatment decisions. RNXtract is an RNA extraction kit designed for routine clinical use with FFPE samples. The company also provides the MammaTyper Report Generator, a companion web platform that accepts data from multiple real-time PCR instruments to calculate and report molecular subtypes. The portfolio enables accurate, reproducible breast cancer classification to guide targeted therapy selection.
Differentiator
Problem solved
Functional benefit
Brands
- MammaTyper®: RT-qPCR assay for breast cancer subtyping, quantifying four key biomarkers: ERBB2 (HER2), ESR1 (estrogen receptor 1), PGR (progesterone receptor), and MKI67 (Ki-67).
- RNXtract®
Products and services
- MammaTyper® An IVD RT-qPCR (reverse transcription quantitative real-time PCR) assay for molecular subtyping of breast cancer. Quantifies four key biomarkers—ER (ESR1), PR (PGR), HER2 (ERBB2), and Ki-67 (MKI67)—to determine breast cancer subtypes including Luminal A-like, Luminal B-like (HER2 negative), Luminal B-like (HER2 positive), HER2 positive (non-luminal), and Triple negative. Designed for clinical pathology laboratories and oncology healthcare providers for treatment decision support.
- RNXtract® An IVD product designed for routine clinical use to extract and purify total RNA from formalin-fixed, paraffin-embedded (FFPE) samples using magnetic beads. Provides a fast, reliable method for obtaining high-quality, amplifiable RNA for subsequent molecular biology techniques including RT-qPCR testing, intended for clinical pathology laboratories.
- MammaTyper® Report Generator Web-based software tool for generating MammaTyper® test reports. Accepts data import from various real-time PCR instruments including LightCycler480 II, cobas480, SLAN-96P, CFX96, AriaDx, MX3000P, ABI7500, and Versant kPCR systems. Calculates molecular subtypes using the 40-ΔΔCq algorithm with defined cut-offs for ERBB2, ESR1, PGR, and MKI67 biomarkers, and displays CE marking.
Quantifiable outcome
- 95% concordance for HER2 testing vs FISH reference standard, meeting ASCO-CAP guidelines requirement
- +3 more outcomes
Companies that use Cerca Biotech
Customer profileSegments3 records
Ideal customer profiles2 records
Cerca Biotech technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Cerca Biotech partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Shuwen BiotechcoreShuwen Biotech is the parent company of Cerca Biotech. Cerca Biotech GmbH, based in Berlin, is the European subsidiary of Shuwen Biotech, described as a highly reputable and innovative molecular and point of care diagnostics organization. Both companies are passionate about healthcare and working to create world leading innovations in oncology and women's health diagnostics.
Scale indicators3 records
Recent moves6 records
Expansion highlights5 records
Cerca Biotech competitors and assessment
Company assessmentDirect peers
- NanoString Technologies: Originally developed the Prosigna/PAM50 test using nCounter gene expression technology for breast cancer subtyping. Directly comparable molecular diagnostics peer in breast cancer classification.
- Agendia: Provider of MammaPrint and BluePrint tests for breast cancer recurrence risk and molecular subtyping. Direct competitor in the same breast cancer molecular diagnostics category.
- Veracyte: Molecular diagnostics company that acquired the Prosigna/PAM50 breast cancer subtyping test. Competes directly with MammaTyper in the same clinical decision-support category for breast cancer.
- Biotheranostics: Developer of the Breast Cancer Index (BCI), a molecular test predicting recurrence risk and benefit of extended endocrine therapy in breast cancer. Comparable niche player in breast cancer prognostic diagnostics.
- Myriad Genetics: Developer of Oncotype DX Breast Recurrence Score, the leading multigene breast cancer prognostic test. Direct competitor to MammaTyper in guiding chemotherapy and endocrine therapy decisions in breast cancer.
Broad incumbents
- Roche Diagnostics: Operates a broad IVD and molecular diagnostics portfolio including the cobas and LightCycler qPCR platforms that MammaTyper is compatible with. Adjacent incumbent that could either partner with or squeeze out smaller PCR-based test developers.
- Hologic: Women's health diagnostics leader with strong presence in breast cancer screening and cytology. Comparable focus on women's health oncology, though more entrenched in imaging/cytology than molecular subtyping.
- QIAGEN: Provider of sample-prep and molecular diagnostic technologies used in PCR workflows, including companion diagnostic development. Comparable business model in IVD molecular testing infrastructure and reagents.
- Exact Sciences: Acquired Oncotype DX through its Thrive and Genomic Health transactions and operates a broad oncology diagnostics platform. Competes in breast cancer subtyping as part of a much larger molecular diagnostics portfolio.
Others
- Bio-Techne: Supplies reagents, proteins, and molecular biology tools used in RT-qPCR and biomarker workflows. Comparable as an enabling life science tools vendor that participates in the same molecular diagnostics value chain.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Cerca Biotech social profiles
Digital presenceCerca Biotech compliance and trust
Trust signalCompliance3 records
Cerca Biotech financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cerca Biotech leadership team
Management profileNumber of profiles
Profiles6 records
Cerca Biotech funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cerca Biotech 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 Cerca Biotech
What does Cerca Biotech do?
Cerca Biotech manufactures and markets IVD molecular diagnostic products for breast cancer. Its flagship product, MammaTyper®, is an RT-qPCR assay that quantifies four biomarkers (ER, PR, HER2, Ki-67) to determine molecular breast cancer subtypes. The complementary RNXtract® kit extracts RNA from FFPE samples using magnetic beads, and the MammaTyper® Report Generator is a web-based software tool for calculating subtypes from multiple qPCR instruments.
Is Cerca Biotech a public or private company?
Cerca Biotech is a private company. It is classified as corporate owned and is currently operating.
When was Cerca Biotech founded?
Cerca Biotech was founded in 2021. It employs 1 to 10 people.
Where is Cerca Biotech based?
Cerca Biotech is headquartered in Berlin, Germany, in the Europe region.
How does Cerca Biotech make money?
Two revenue lines are on record. MammaTyper® Diagnostic Test Kits are the primary driver. The others are RNXtract® RNA Extraction Products.
Who are Cerca Biotech's main competitors?
Direct peers on record are NanoString Technologies, Agendia, Veracyte, Biotheranostics and Myriad Genetics. Broad incumbents are Roche Diagnostics, Hologic, QIAGEN and Exact Sciences. Bio-Techne is listed as an others.
Does Cerca Biotech have an API?
No public API is recorded for Cerca Biotech.
What industry is Cerca Biotech in?
Cerca Biotech's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAAALAA, Molecular Diagnostics (PCR/qPCR, NGS-based assays), with a secondary code of HLAHAAAD, Molecular Diagnostics (PCR/NAAT/NGS-based IVD). Its NAICS code is 325413 and its SIC code is 2835.