Menarini Silicon Biosystems

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.

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

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

• Liquid biopsy diagnostics
• Circulating tumor cells
• Cell-based diagnostics
• Noninvasive prenatal testing
• Laboratory developed tests

Headquarters

HQ city

Bologna

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. 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.
2. 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.
3. 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

Core 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

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Broad 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

• Xx.com/SiliconBio
• Facebookfacebook.com/silicon-biosystems-usa-166836340018315
• LinkedInlinkedin.com/company/silicon-biosystems

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds3 records

Investors2 records

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 Menarini Silicon Biosystems