Bioclarma

What Bioclarma does

Bioclarma Srl is a privately held Italian molecular diagnostics company headquartered in Turin, Italy, operating since 2007. The company manufactures CE/IVD marked Real-Time PCR diagnostic kits under its SensiQuant and SMART SNP product lines, targeting hospital diagnostic laboratories and research institutions. Core products cover oncohematology (BCR-ABL, PML-RARa, CBFB/MYH11, AML1-ETO, TEL-AML1 translocations for leukemia diagnosis and monitoring), human genetics (Factor II, Factor V Leiden, MTHFR C677T/A1298C for thrombophilia screening), and virology (SARS-CoV-2 detection). The company's technology differentiates through One-Step PCR combining reverse transcription and amplification in a single tube, and direct testing methods that eliminate DNA extraction requirements, enabling throughput of up to 280 samples per day with a linear detection range of 1,000,000 to 10 copies.

Bioclarma's business model combines product sales (IVD kits sold in standardized reaction formats with quote-based pricing), distribution partnerships (exclusive Italian distribution of Panagene PNA products and exclusive global distribution of Biomole pharmacogenetics/rare disease kits), and fee-for-service laboratory analysis (Luminex multiplex analysis, proteomics, ddPCR, molecular biology, and immunoassay services). Go-to-market is direct B2B enterprise sales to hospital labs and research institutions via email, quote requests, and specialized sales contacts. The company holds ISO 9001 and ISO 13485 certifications, demonstrating compliance with quality management and medical device manufacturing standards. With a registered share capital of €69,240 and no disclosed external funding, the company operates as a self-funded, niche specialty diagnostics provider with a small management team and two Turin office locations (Via Petrarca for headquarters and Via Nizza for the R&D laboratory).

Name

Bioclarma

Legal name

Bioclarma Srl

Website

https://bioclarma.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

51–100 employees

Short description

Bioclarma is a Turin-based Italian molecular diagnostics company that manufactures CE/IVD Real-Time PCR kits for oncohematology (leukemia translocations), human genetics (thrombophilia SNPs), and virology, serving hospital diagnostic laboratories and research institutions worldwide through direct B2B sales and distribution partnerships.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)

akta.pro secondary industries

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Molecular diagnostics kits
• In-vitro diagnostics
• Real-time PCR assays
• Oncohematology diagnostics
• Clinical genetics testing

Headquarters

HQ city

Turin

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Diagnostic Kits Sales: Sale of CE/IVD marked diagnostic kits including SensiQuant product line for oncohematology (BCR-ABL, PML/RARa, CBFB/MYH11, AML1-ETO, TEL-AML1), SMART SNP line for human genetics (Factor II, Factor V Leiden, MTHFR), and SARS-CoV-2 detection kits. One-time purchase of diagnostic kits with consumables revenue.
2. Research Services: Analysis services provided to research laboratories including Luminex analysis, proteomics, molecular biology (ddPCR, Real-Time PCR, FISH, Spectral Karyotyping), and immunoassays. Custom assay development and validation services.
3. Distribution of Partner Products: Revenue from distribution partnerships including Panagene PNA products in Italy and Biomole products globally, providing synthesis of PNA oligonucleotides, FISH probes, monomers, and Real-Time PCR kits for pharmacogenetics and rare diseases.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels4 records

Core offering

Bioclarma manufactures and distributes CE/IVD-marked Real-Time PCR diagnostic kits for molecular diagnostics across oncohematology (BCR-ABL, PML-RARa, CBFB/MYH11, AML1-ETO, TEL-AML1), human genetics (Factor II, Factor V Leiden, MTHFR), and virology (SARS-CoV-2), and provides fee-for-service laboratory analyses including Luminex multiplex assays, ddPCR, Real-Time PCR development, FISH/Spectral Karyotyping, proteomics, and immunoassays. The company also serves as the exclusive distributor of Panagene PNA products in Italy and Biomole Real-Time PCR kits globally.

Product overview

Bioclarma is an Italian molecular diagnostics company offering a portfolio of IVD kits and laboratory services. The product portfolio consists of three main IVD kit lines: (1) SensiQuant and SensiQuant Direct product lines for oncohematology testing including BCR-ABL (P210, P190, P230 variants), PML-RARa (BCR1/2/3), CBFB/MYH11, AML1-ETO, and TEL-AML1 translocations using One-Step Real-Time PCR technology; (2) SMART SNP product line for human genetics including Factor II (FII), Factor V Leiden (FVL), and MTHFR (C677T, A1298C) SNPs with direct testing without DNA extraction; and (3) SensiQuant SARS-CoV-2 for virology. Additionally, Bioclarma distributes Panagene PNA products (custom PNA synthesis, FISH probes, monomers) in Italy and Biomole products globally (pharmacogenetics, rare disease, and stemness Real-Time PCR kits). The company also provides fee-for-service laboratory analysis including Luminex multiplex analysis, molecular biology services (ddPCR, Real-Time PCR, FISH), proteomics services, and immunoassay services for research and diagnostic applications.

Differentiator

Problem solved

Functional benefit

Brands

• SensiQuant: Product line for qualitative and quantitative detection of nucleic acids, including Real-Time PCR kits for oncohematology and virology applications.
• SMART SNP
• Lyoset Reference
• PhilaREF

Products and services

• SensiQuant SARS-CoV-2
• SensiQuant BCR-ABL (P210, P190, P230 and rare variants)
• SensiQuant PML-RARa (BCR1, BCR2, BCR3)
• SensiQuant CBFB/MYH11 (INV-16A, INV-16D, INV-16E)
• SensiQuant AML1-ETO
• SensiQuant TEL-AML1
• SMART SNP FII Direct Kit
• SMART SNP FVL Direct Kit
• SMART SNP MTHFR 1298 Direct Kit
• SMART SNP MTHFR 677 Direct Kit
• Panagene PNA Products
• Biomole Real-Time PCR Kits (Pharmacogenetics, Rare Diseases, Stemness)
• Luminex Analysis Services
• Molecular Biology Services
• Proteomics Services
• Immunoassay Services

Quantifiable outcome

• High analytical throughput of up to 280 samples/day for genetic testing
• +2 more outcomes

Named customers4 records

Segments4 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

Partnerships

One partnership is on record.

• BiomolecoreChannel Partner/ Reseller/ DistributorBioclarma is the exclusive global distributor and partner of Biomole, an Italian company founded in 2019 that provides Real-Time PCR kits for applications in pharmacogenetics, rare diseases, and stem cell analysis. Products include kits for detection of PHP1b, H19, IGF2, KCNQ1OT1, CDKN1C, Complementopathies, McCune-Albright syndrome, Interferonopathies, Gilbert's Syndrome, TPMT, NUDT15, FCGR2B, MT-RNR1, stemness markers (NANOG, OCT4, SOX2), and cellular differentiation markers.

Scale indicators6 records

Recent moves5 records

Expansion highlights6 records

Direct peers

• DiaSorin: DiaSorin is an Italian-headquartered IVD company with molecular diagnostics and specialty immunoassay products sold globally. Highly comparable to Bioclarma as a fellow Turin/Italy-based IVD manufacturer serving hospital labs, though at much larger scale.
• Sentinel Diagnostics: Sentinel Diagnostics is an Italian IVD manufacturer producing clinical chemistry and molecular diagnostic kits sold to hospital labs. Directly comparable as a fellow Italian IVD kit supplier targeting similar hospital laboratory customers.
• Panagene: Panagene is a specialist in PNA (Peptide Nucleic Acid) oligonucleotides, FISH probes, and molecular biology reagents for diagnostic and research applications. Directly comparable as both a technology peer and an active distribution partner of Bioclarma in Italy.
• ELITech Group: ELITech is a European mid-sized IVD company specializing in molecular diagnostics kits for infectious disease and genetics, distributed through hospital labs. Closely comparable to Bioclarma in size, product menu (PCR-based IVD kits), and go-to-market approach.
• Biomole: Biomole is an Italian developer of Real-Time PCR kits for pharmacogenetics, rare diseases, and stem cell analysis founded in 2019. Directly comparable as both a technology peer in molecular diagnostics and Bioclarma's exclusive global distribution partner.

Broad incumbents

• Eurofins Genomics: Eurofins Genomics is a global provider of genomic services including PCR, sequencing, and custom assay development. Comparable to Bioclarma's laboratory services arm (Luminex, ddPCR, proteomics, immunoassays) at vastly larger scale.
• Qiagen: Qiagen is a global leader in molecular diagnostics and sample-preparation technologies with a broad PCR and IVD menu. Directly comparable to Bioclarma as a molecular diagnostics IVD supplier, but vastly larger in scale and portfolio breadth.
• Bio-Rad Laboratories: Bio-Rad offers a broad molecular biology and clinical diagnostics portfolio including PCR reagents, qPCR systems, and IVD assays. Comparable as a molecular diagnostics reagent and kit supplier with overlapping customer base in hospital and research labs.
• Cepheid (Danaher): Cepheid, part of Danaher, sells the GeneXpert molecular diagnostics system widely deployed in hospital labs globally. Comparable as a molecular PCR diagnostics IVD supplier, though focused on automated cartridge-based platforms rather than open PCR kits.

Regional players

• AB ANALITICA: AB ANALITICA is an Italian IVD manufacturer focused on molecular diagnostics, clinical chemistry, and microbiology reagents distributed to hospital and clinical labs. Closely comparable as a regional (Italian) molecular diagnostics IVD peer serving similar hospital laboratory customers.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/bioclarma

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Bioclarma