Biovica International

What Biovica International does

Biovica International AB is a Swedish cancer diagnostics company that develops and commercializes DiviTum TKa, a blood-based biomarker assay that measures thymidine kinase 1 activity (TKa) as an indicator of cell proliferation in solid tumors. The product is FDA 510(k) cleared (May 2022) and CE marked, and is positioned for treatment monitoring in metastatic breast cancer — particularly HR+/HER2- patients on CDK4/6 inhibitors — with exploratory data in NSCLC and other solid tumors. The underlying chemistry is protected by US patents 8,765,378 and 9,376,707 with patent coverage in 49 countries, and the company has accumulated evidence across 4,500+ patients, 28 publications, and 32 active pharma projects.

Biovica operates a dual revenue model: (1) commercial diagnostic testing through direct enterprise sales to US oncology practices, supported by a strategic partnership with Tempus and a commercial agreement with the NCI Center; and (2) pharma services, providing TKa biomarker incorporation into clinical trials for patient selection, response monitoring, and CDK inhibitor dose optimization, with contract value having nearly doubled to approximately USD 2.5M. Pricing is not publicly disclosed, though Medicare reimbursement has been secured for the US market.

Following a strategic decision not to pursue European IVDR certification, Biovica concentrates commercialization on the United States, where it operates a wholly-owned subsidiary, Biovica Inc., based in San Diego. The company is publicly listed on Nasdaq First North Premier Stockholm, has 11–50 employees, and is in a capital-intensive growth phase: full-year FY 2025/26 sales of SEK 13.4M were offset by a single-quarter operating loss of SEK -17.8M, with SEK 70.4M of cash providing approximately 12 months of runway. Leadership transitioned in 2026, with Theis Kipling (formerly CCO at Devyser and Atlas Antibodies) succeeding long-tenured CEO Anders Rylander.

Name

Biovica International

Legal name

Biovica International AB

Website

https://biovica.com

Company type

Public

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Biovica International is a Swedish diagnostics company commercializing DiviTum TKa, an FDA-cleared blood-based biomarker assay that monitors cancer treatment response by measuring thymidine kinase 1 activity, serving US oncologists and pharmaceutical companies.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Cancer biomarker assays
• Blood-based diagnostics
• Treatment monitoring tests
• Companion diagnostics
• Thymidine kinase assays

Headquarters

HQ city

Uppsala

HQ country

Sweden

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. DiviTum® TKa Commercial Testing: Revenue from commercial sales of the DiviTum® TKa test to oncology practices and healthcare providers in the US market. Q4 2026 sales reached SEK 4.8 million with full-year sales of SEK 13.4 million, representing 55% growth in Swedish krona and 74% in local currency.
2. Pharma Services: Contract research services provided to pharmaceutical companies incorporating DiviTum® TKa as a biomarker for patient selection and treatment response in clinical trials. Contract value has nearly doubled to approximately USD 2.5 million.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Biovica develops and commercializes DiviTum® TKa, a CE-marked and FDA 510(k)-cleared blood-based biomarker assay that measures thymidine kinase 1 activity (TKa) from solid tumors to monitor cancer treatment response and disease progression. The company sells the diagnostic test to US oncology practices and provides pharma services to drug developers incorporating TKa into clinical trials for patient selection and treatment monitoring.

Product overview

Biovica International offers a single core diagnostic product: DiviTum® TKa, a CE-marked and FDA 510(k)-cleared blood-based biomarker assay designed for cancer treatment monitoring. The test measures thymidine kinase 1 activity (TKa) as a marker of cell proliferation from solid tumors, enabling clinicians to monitor disease progression and treatment response. The company serves pharma companies through clinical trial biomarker services and clinical laboratories through commercial diagnostic testing. DiviTum® TKa is protected under US Patent Nos. 8,765,378 and 9,376,707 with patent protection in 49 countries.

Differentiator

Problem solved

Functional benefit

Brands

• DiviTum® TKa: Blood-based biomarker assay for monitoring disease progression in cancer patients, measuring cell proliferation from solid tumors. CE marked in Europe and FDA 510(k) cleared in the United States.

Products and services

• DiviTum TKa Test DiviTum TKa is a CE-marked and FDA 510(k)-cleared blood-based biomarker assay that measures thymidine kinase 1 activity (TKa) from solid tumors to monitor cancer treatment response and disease progression. It is used by oncologists and cancer treatment centers to provide clinical insights up to 83 days before imaging in metastatic breast cancer and other solid tumor cancers.
• Pharma Services (DiviTum TKa Clinical Trial Biomarker Services) Contract research services provided to pharmaceutical companies incorporating DiviTum TKa as a pharmacodynamic biomarker for patient selection and treatment response monitoring in oncology clinical trials, including prospective trial biomarker incorporation and retrospective analysis on banked patient samples.

Quantifiable outcome

• Clinical insights up to 83 days before imaging
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• TempuscoreStrategic or Co-development Partner · 13 May 2025Strategic partnership with Tempus for commercial launch of DiviTum® TKa in the United States. Tempus provides commercial reach and market access capabilities to accelerate US adoption of the DiviTum TKa test.
• NCI CentercoreStrategic or Co-development PartnerNew commercial agreement with NCI Center in the USA for commercial distribution and adoption of DiviTum® TKa testing services.
• Roswell Park Comprehensive Cancer CenterminorStrategic or Co-development PartnerPublished positive clinical trial data from studies at Roswell Park Comprehensive Cancer Center supporting DiviTum TKa in cancer treatment monitoring.

Scale indicators9 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Natera: Natera develops cell-free DNA-based tests including Signatera for molecular residual disease and treatment monitoring in oncology. Comparable as a blood-based oncology monitoring test provider, with a focus on tumor-informed testing in solid tumors similar to Biovica's solid tumor monitoring use case.
• Guardant Health: Guardant Health is a leading liquid biopsy company offering blood-based oncology tests for treatment monitoring and recurrence detection. Directly comparable to Biovica in targeting blood-based biomarkers for oncology treatment decisions, though with a broader multi-gene panel approach versus Biovica's single biomarker (TKa) focus.
• Tempus: Tempus is an oncology technology and diagnostics company that partnered with Biovica for US commercialization. Comparable as an AI-enabled oncology data and diagnostics platform serving both oncologists and pharma companies for treatment selection and trial enrollment.
• Foundation Medicine: Foundation Medicine (a Roche subsidiary) provides comprehensive genomic profiling of solid tumors used to guide treatment selection in oncology. Comparable as a tumor biomarker profiling and oncology treatment decision support company, though broader in scope than Biovica's single-biomarker approach.
• Exact Sciences: Exact Sciences commercializes Cologuard for colorectal cancer screening and Oncotype DX for breast cancer treatment selection. Comparable as a publicly traded oncology diagnostics company with established US commercial infrastructure serving oncologists, similar to Biovica's target customer base.
• Bio-Techne: Bio-Techne develops reagents, assays, and biomarker test kits used in life sciences research and clinical diagnostics. Comparable to Biovica in providing biomarker assay technologies to pharma and clinical labs, with a broader portfolio of proteomic and cell biology reagents.
• Caris Life Sciences: Caris Life Sciences offers molecular profiling and AI-driven biomarker analysis for oncology treatment selection and monitoring. Comparable to Biovica in providing biomarker-based decision support to oncologists and pharma companies for clinical trial applications.
• NeoGenomics: NeoGenomics provides oncology-focused clinical laboratory and pharma services including biomarker testing for clinical trials. Directly comparable to Biovica in pharma services and oncology diagnostics, with a broader menu of tests across multiple cancer types.

Broad incumbents

• Agilent Technologies: Agilent acquired Dako and has a major companion diagnostics and pathology business serving pharma and clinical labs. Comparable as a broader incumbent in the oncology diagnostics and companion diagnostics space where Biovica is also active, with Biovica's SVP BD Henrik Winther having led Dako/Agilent CDx previously.

Others

• Roche Diagnostics: Roche Diagnostics is a global leader in clinical diagnostics and oncology biomarker testing through its cobas and Foundation Medicine businesses. Comparable as a broad incumbent in oncology diagnostics and pharma services, providing IVD platforms that compete with Biovica's specialized TKa assay.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/Biovica
• YouTubeyoutube.com/channel/UC_q6sO8dSXJ_x0uxO5ALMmQ/videos
• Facebookfacebook.com/biovica
• LinkedInlinkedin.com/company/biovica-international-ab

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds7 records

Investors1 record

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 Biovica International