Menarini Silicon Biosystems
Menarini Silicon Biosystems is an Italian-American specialty diagnostics subsidiary of Menarini Group that operates the FDA-cleared CELLSEARCH liquid biopsy platform for circulating tumor cell, multiple myeloma cell, and cell-based non-invasive prenatal testing, serving oncology providers, biopharma partners, and academic researchers.
- Company typePrivate
- Founded2005
- HeadquartersBologna, Italy
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Menarini Silicon Biosystems does
Menarini Silicon Biosystems (MSB) is a Bologna, Italy-based specialty diagnostics company and wholly-owned subsidiary of the privately-held Menarini Group, focused on liquid biopsy and cell-based diagnostic testing. Founded in 2005, the company operates with 51-100 employees across its Italian headquarters in Castel Maggiore (Bologna) and a US subsidiary in Huntingdon Valley, Pennsylvania, with its core platform being CELLSEARCH®, the first and only FDA-cleared actionable test for detecting and enumerating circulating tumor cells (CTCs) in patients with metastatic breast, prostate, and colorectal cancer.
The company's technology portfolio extends beyond solid-tumor CTC enumeration to include biomarker phenotyping (notably HER2 testing on captured CTCs), circulating multiple myeloma cell (CMMC) enumeration, circulating melanoma cell (CMC) enumeration, and cell-based non-invasive prenatal testing (CB-NIPT) for fetal genomic abnormality detection from maternal blood. Clinical validation is anchored in trials including the PACE study (203 HR+/HER2- metastatic breast cancer patients progressing after first-line treatment, with reported 57% and 74% progression risk reductions in aggressive-disease patients on doublet and triplet therapy respectively) and DETECT III, with results published in peer-reviewed venues such as Clinical Cancer Research through 2025.
MSB operates a hybrid business model with three revenue streams: (1) direct laboratory diagnostic services delivered through an ordering portal to oncologists, hematologists, and prenatal care providers; (2) biopharma clinical trial lab services supporting patient stratification, treatment monitoring, and trial endpoints; and (3) product sales of CELLSEARCH reagent kits and blood collection tubes to laboratories performing in-house testing. Customer segments span oncology healthcare providers (primary), hematology/oncology specialists, prenatal care providers, biopharmaceutical companies, and academic research institutions. As a privately-held Menarini Group subsidiary, MSB does not disclose revenue or accept external investment.
Menarini Silicon Biosystems firmographics
Firmographics- Name
- Menarini Silicon Biosystems
- Legal name
- Menarini Silicon Biosystems SpA
- Website
- https://siliconbiosystems.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Menarini Silicon Biosystems is an Italian-American specialty diagnostics subsidiary of Menarini Group that operates the FDA-cleared CELLSEARCH liquid biopsy platform for circulating tumor cell, multiple myeloma cell, and cell-based non-invasive prenatal testing, serving oncology providers, biopharma partners, and academic researchers.
- Ownership category
- akta.pro rank
Menarini Silicon Biosystems industry classification
Industry- Product category
- Liquid Biopsy Diagnostics
- NAICS
- Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)
Keywords
Where Menarini Silicon Biosystems is headquartered
LocationHeadquarters
- HQ city
- Bologna
- HQ country
- Italy
- HQ region
- Europe
Offices2 records
Markets served
Menarini Silicon Biosystems business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain, Infrastructure
Revenue model
- Laboratory Diagnostic Services: The company operates clinical laboratories providing diagnostic testing services directly to healthcare providers. Tests include CTC enumeration, biomarker phenotyping, and cell-based prenatal testing. Revenue is generated through test ordering by physicians and healthcare institutions.
- Biopharma Clinical Trial Services: Clinical lab services supporting biopharma partners and clinical trials. Revenue generated from pharmaceutical companies using MSB's testing capabilities for patient stratification, treatment monitoring, and clinical trial endpoints.
- Product Sales (Reagent Kits and Blood Collection Tubes): Sale of CELLSEARCH® reagent kits and blood collection tubes to laboratories and healthcare institutions that perform their own testing.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
Menarini Silicon Biosystems product offering
Product offeringCore offering
Menarini Silicon Biosystems operates clinical laboratories providing cell-based diagnostic tests built on the proprietary CELLSEARCH® platform. Core offerings include the FDA-cleared CELLSEARCH® Circulating Tumor Cell (CTC) Test for metastatic breast, prostate, and colorectal cancer, the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Test, and a suite of Laboratory Developed Tests (LDTs) for biomarker phenotyping, CMC enumeration, and cell-based non-invasive prenatal testing (CB-NIPT). The company also sells CELLSEARCH reagent kits and blood collection tubes, and provides lab services to biopharma partners for clinical trials.
Product overview
Menarini Silicon Biosystems offers a unified platform of cell-based diagnostic tests centered on its proprietary CELLSEARCH technology for liquid biopsy applications. The core portfolio includes the CELLSEARCH Circulating Tumor Cell (CTC) Test and CELLSEARCH Circulating Multiple Myeloma Cell (CMMC) Test, both of which are supported by specialized reagent kits and blood collection tubes. These are complemented by a suite of Laboratory Developed Tests (LDTs) including CTC Enumeration, Biomarker Phenotyping, CMC Enumeration, and CMMC Enumeration for solid tumor and hematologic malignancy applications. The company also provides Cell-Based Noninvasive Prenatal Testing (CB-NIPT) for prenatal diagnostics. The portfolio is supported by laboratory services for biopharma partners conducting clinical trials and academic researchers, creating an integrated ecosystem spanning oncology, hematology, and prenatal testing markets.
Differentiator
Problem solved
Functional benefit
Brands
- CELLSEARCH: The first and only actionable test for detecting circulating tumor cells (CTCs) in cancer patients with metastatic breast, prostate, or colorectal cancer. Also available for circulating multiple myeloma cell testing.
- CellSearch CTC Test
- Cell-Based Noninvasive Prenatal Testing (CB-NIPT)
Products and services
- CELLSEARCH® Circulating Tumor Cell (CTC) Test The first and only FDA-cleared actionable test for detecting and enumerating circulating tumor cells in patients with metastatic breast, prostate, or colorectal cancer, providing prognostic and predictive information to guide treatment decisions.
- CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Test A standardized, reliable, and minimally invasive laboratory-developed test for serially monitoring multiple myeloma and precursor conditions through a simple blood draw, enabling disease tracking and treatment response assessment.
- CTC Enumeration Laboratory Developed Test Laboratory-developed test service providing circulating tumor cell enumeration for solid tumor applications including breast, prostate, and colorectal cancers, guiding treatment decisions.
- Biomarker Phenotyping Laboratory Developed Test Laboratory-developed test service that characterizes biomarkers on captured circulating tumor cells, including HER2 testing, enabling personalized treatment selection beyond basic CTC enumeration.
- CMC Enumeration Laboratory Developed Test Laboratory-developed test service for detecting and enumerating circulating melanoma cells in melanoma patients, supporting disease monitoring and treatment guidance.
- Cell-Based Noninvasive Prenatal Testing (CB-NIPT) Cell-based noninvasive prenatal testing that analyzes fetal cells from a maternal blood draw for high-resolution detection of fetal genomic abnormalities, including aneuploidies and microdeletions.
- CELLSEARCH® Reagent Kits Specialized reagent kits used with the CELLSEARCH system for processing and analyzing blood samples for CTC and CMMC enumeration, sold to laboratories performing their own testing.
- CELLSEARCH® Blood Collection Tubes Specialized blood collection tubes that preserve and transport blood samples for CTC analysis, maintaining sample integrity during shipment to the laboratory.
- Biopharma Clinical Trial Lab Services Clinical laboratory services supporting biopharma partners and clinical trials with CTC and CMMC testing capabilities for patient stratification, treatment monitoring, and trial endpoints.
- Custom Research Lab Services Custom research laboratory services supporting academic and research projects with specialized cell-based analysis capabilities leveraging MSB's rare cell isolation technologies.
Quantifiable outcome
- 57% reduction in progression risk with doublet therapy and 74% reduction with triplet therapy in patients with 5+ CTCs per 7.5mL blood
Companies that use Menarini Silicon Biosystems
Customer profileSegments5 records
Ideal customer profiles4 records
Menarini Silicon Biosystems technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Menarini Silicon Biosystems partnerships and signals
Strategic signalScale indicators2 records
Recent moves6 records
Expansion highlights5 records
Menarini Silicon Biosystems competitors and assessment
Company assessmentBroad incumbents
- Foundation Medicine (Roche): Foundation Medicine provides comprehensive genomic profiling (FoundationOne CDx, FoundationOne Liquid CDx) and competes with CELLSEARCH in oncology biomarker-driven treatment selection, backed by Roche's global commercial reach.
- Roche Diagnostics: Roche Diagnostics is a global in-vitro diagnostics leader with extensive oncology and prenatal testing portfolios (including Foundation Medicine). It competes broadly with MSB's diagnostic testing services and reagent kit sales.
- Exact Sciences: Exact Sciences is a major molecular diagnostics company with Cologuard (CRC screening) and the Oncotype DX franchise. It overlaps with MSB in oncology diagnostics and competes for clinical lab services budgets.
Direct peers
- Natera: Natera offers cell-free DNA-based prenatal testing ( Panorama ) and oncology liquid biopsy products (Signatera for MRD). It competes with both MSB's CELLSEARCH oncology franchise and its CB-NIPT prenatal offering.
- Guardant Health: Guardant Health is a leading liquid biopsy company offering NGS-based ctDNA tests (Guardant360, Guardant Reveal) for oncology therapy selection and MRD monitoring. It directly competes with CELLSEARCH in the oncology liquid biopsy decision-support market.
- NeoGenomics: NeoGenomics is a specialty oncology reference laboratory providing solid tumor and hematologic malignancy testing services, including liquid biopsy assays. It competes directly with MSB's lab services for oncology and multiple myeloma testing.
- Bio-Techne (RareCyte): Bio-Techne acquired RareCyte, which develops liquid biopsy platforms for circulating tumor cell and rare cell detection using similar immunomagnetic/single-cell precision techniques. It is a direct technical peer in rare-cell isolation.
Emerging players
- Personalis: Personalis provides ultrasensitive ctDNA-based MRD testing (NeXT Personal) and oncology molecular profiling. It competes with MSB's CTC-based monitoring approach with an NGS ctDNA alternative.
- Tempus: Tempus offers AI-enabled molecular profiling and liquid biopsy testing (xT, xR, xF) for oncology. It is an emerging direct competitor in oncology biomarker testing and biopharma clinical trial services.
Others
- Menarini Group: MSB's parent company and global pharmaceutical conglomerate. Menarini provides strategic oversight, distribution channels, and corporate-quality infrastructure, and is the source of MSB's clinical research and commercial alignment.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Menarini Silicon Biosystems social profiles
Digital presenceMenarini Silicon Biosystems financial estimates
Financial estimateRevenue estimate
Valuation estimate
Menarini Silicon Biosystems leadership team
Management profileNumber of profiles
Profiles8 records
Menarini Silicon Biosystems funding detail
Funding detailFunding overview
Funding rounds3 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Menarini Silicon Biosystems 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 Menarini Silicon Biosystems
What does Menarini Silicon Biosystems do?
Menarini Silicon Biosystems operates clinical laboratories providing cell-based diagnostic tests built on the proprietary CELLSEARCH® platform. Core offerings include the FDA-cleared CELLSEARCH® Circulating Tumor Cell (CTC) Test for metastatic breast, prostate, and colorectal cancer, the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Test, and a suite of Laboratory Developed Tests (LDTs) for biomarker phenotyping, CMC enumeration, and cell-based non-invasive prenatal testing (CB-NIPT). The company also sells CELLSEARCH reagent kits and blood collection tubes, and provides lab services to biopharma partners for clinical trials.
Is Menarini Silicon Biosystems a public or private company?
Menarini Silicon Biosystems is a private company. It is classified as corporate owned and is currently operating.
When was Menarini Silicon Biosystems founded?
Menarini Silicon Biosystems was founded in 2005. It employs 51 to 100 people.
Where is Menarini Silicon Biosystems based?
Menarini Silicon Biosystems is headquartered in Bologna, Italy, in the Europe region.
How does Menarini Silicon Biosystems make money?
Three revenue lines are on record. Laboratory Diagnostic Services are the primary driver. The others are biopharma Clinical Trial Services and product Sales (Reagent Kits and Blood Collection Tubes).
Who are Menarini Silicon Biosystems's main competitors?
Broad incumbents on record are Foundation Medicine (Roche), Roche Diagnostics and Exact Sciences. Direct peers are Natera, Guardant Health, NeoGenomics and Bio-Techne (RareCyte). Emerging players are Personalis and Tempus. Menarini Group is listed as an others.
Does Menarini Silicon Biosystems have an API?
No public API is recorded for Menarini Silicon Biosystems.
What industry is Menarini Silicon Biosystems in?
Menarini Silicon Biosystems's product category is Liquid Biopsy Diagnostics. Its primary akta.pro industry code is HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy). Its NAICS code is 621511 and its SIC code is 2835.