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Clinical validation of the DiviTum assay in two high profile clinical studies in Europe

Total Cost €


EC-Contrib. €






Project "BIOVALID" data sheet

The following table provides information about the project.


Organization address
postcode: 752 37
website: n.a.

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Sweden [SE]
 Project website
 Total cost 682˙506 €
 EC max contribution 682˙506 € (100%)
 Programme 1. H2020-EU.3.1. (SOCIETAL CHALLENGES - Health, demographic change and well-being)
2. H2020-EU.2.3.1. (Mainstreaming SME support, especially through a dedicated instrument)
 Code Call H2020-SMEINST-2-2015
 Funding Scheme SME-2
 Starting year 2015
 Duration (year-month-day) from 2015-09-01   to  2021-11-30


Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    BIOVICA INTERNATIONAL AB SE (UPPSALA) coordinator 682˙506.00


 Project objective

The traditionally practiced approach to cancer therapy and development of new cancer drugs is to treat a large pool of patients as potential responders. This results in patients not receiving the optimal treatment; payers paying for treatments that do not benefit patients; drug developers facing higher risk of regulatory failure due to not being able to use better tools for selection of patients in the clinical development program; and clinicians lacking predictive and monitoring tools to administer optimal treatment of patients. Our company has developed a state-of-the-art assay kit - DiviTum™, for the serum-based detection of Thymidine Kinase (TK) activity – a key enzyme involved in cell proliferation. There is compelling scientific rationale to use TK as a biomarker for drugs that disrupt cell cycle regulation, such as Cyclin Dependent Kinase (CDK) inhibitors. As part of the previously conducted SME Instrument Phase 1 feasibility study, our company has identified the clinical study & research market segment, comprised of pharma companies that develop CDK inhibitors, as a current target for the commercialization of DiviTum™. Our company has successfully negotiated to be part of two high-profile clinical studies involving a novel CDK inhibitor with leading oncology institutes in Europe. A clinically validated DiviTum™ has the potential to become the gold standard predictive and efficacy biomarker for cell cycle regulating drugs in selected advanced, solid tumors. This will benefit patients through improved utilization of current and novel treatments; payers by saving costs on ineffective treatments; clinicians by providing a critical clinical decision tool; and drug developers by improving clinical trial success rates through optimized cohort selection, shorter time to market and decreased risk of regulatory failure.


List of deliverables.
White Paper Documents, reports 2019-05-30 13:19:07

Take a look to the deliverables list in detail:  detailed list of BIOVALID deliverables.


year authors and title journal last update
List of publications.
2016 Shana Thomas1, Ning Liu1, Rosy (Jingqin) Luo1, Jeremy Hoog1, Mattias Bergqvist2, Magnus Neumüller2, Edward M. Suh2, Zhanfang Guo1, Kiran Vij1, Souzan Sanati1, Matthew Ellis3, Cynthia X. Ma1 1Washington University School of Medicine, St. Louis, MO, 63110; 2 Biovica International AB, Uppsala, Sweden, 3Baylor College of Medicine, Houston, TX, 77030
Serum Thymidine Kinase 1 Activity as a Pharmacodynamics Marker of Cyclin-Dependent Kinase 4/6Inhibition in Patients with Early Stage Breast Cancer Receiving Neoadjuvant Palbociclib
published pages: , ISSN: , DOI:
San Antonio Breast Cancer Symposium, SABCS 2016, Abstract P5-04-02 ANNUAL 2018-03-29

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