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A novel microfluid-based modular system to address POC challenges within the field of coagulation and hemostasis

Periodic Reporting for period 1 - POC products (A novel microfluid-based modular system to address POC challenges within the field of coagulationand hemostasis)

Reporting period: 2015-07-01 to 2015-12-31

Innovative iLine Microsystems designs, integrates and manufactures customized Point-of-Care (POC) platforms for In-Vitro Diagnostics on the hemostasis field exploiting the advantages of both microfluidics and Lab-on-a-Chip technological concepts. Early 2011 the user friendly microINR system was launched. Flagship of the company, it attains the most stringent quality standards for anti-vitamin K Oral Anticoagulation Therapy (OAT) monitoring through patented proprietary technology.
The company’s Core Technology comprises means for chip (test strip) manufacturing, based in micro engineering and microfabrication processes, which allow massive production combining high quality with significant cost efficiency. An enriched know-how by the new modular design of the whole system makes it possible to extend the diagnostic range of the POC devices to the new anticoagulation therapies now reached, if available, only by multistep reactions run in centralized labs.
Numerous studies predict that in 2017 the market for POC devices will reach $ 160 Billion representing 16% of in vitro diagnostic. The project objective is to reach different central laboratory hemostasis test market niches by offering of a POC device test in its place. iLine Microsystems focuses on this business opportunity as this market has not yet begun to take off.
During Phase I of the H2020 SME Program the focus has been on the validation and feasibility study of new IVD POC device prototypes in the field of, but not limited to, novel oral anticoagulants (NOACs). During the phase I the company invested in market studies, expert panels, widened the clinical network and established contacts with KOLs. As a result, a strategy and business plan for the development and marketing of the new product lines was shaped.
The proposed solution, due to its modular design and flexibility, has the unique potential for customization and improvements. It also creates the possibility to diversify the markets and designed products based on biomarkers outside hemostasis and coagulation. Thanks to the proposed solution the company will address the economic and social problem related to patient care.
The decentralized POC diagnostic addresses the urgent need to lower the increasing cost of centralized patient management due to the aging population in the developed countries. By limiting the amount of hemorrhagic incidents, the POC solution will contribute to diminish the overall cost of NOACs-related complications and care.
Micro INR Product
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