Commercialization of ultrasensitive methods for analysis of circulating tumor DNA in cancer patients
|Coordinator||SAGA DIAGNOSTICS AB|
|Funding from Vinnova||SEK 4 700 000|
|Project duration||November 2018 - October 2020|
|Venture||SWElife Steg 2|
|Call||Swelife - Projekt för bättre hälsa steg 2 (2018)|
Purpose and goal
There is an urgent need for improved cancer biomarkers to monitor patients non-invasively. Earlier detection and more accurate response evaluation could significantly improve survival and quality of life. Clinical imaging and protein-based diagnostics are insufficient. To address this, we have developed blood-based ultrasensitive methods to measure circulating tumor DNA. In this project we aim to bring these methods towards commercialization by performing further market research, laboratory and regulatory development, and verification in additional cancer types.
Expected results and effects
Our technologies and methods may be used to steer personalized therapy by identifying targetable gene mutations or resistance mutations, detecting occult metastatic disease at the earliest moment, and sparing cured patients the unnecessary side effects of powerful anti-cancer agents. Analyses of circulating tumor DNA are rapidly becoming part of the standard treatment guidelines and has the potential to both save cost of cancer patient care as well as improve patient survival and quality of life.
Planned approach and implementation
To bring our technologies closer to market, in SWElife phase 2 we have three specific aims:  Business development: market research, product development, and IP protection;  Regulatory development: technology transfer to commercial laboratory, plan and undergo ISO accreditation together with first CE-IVD product approval;  Technical verification: in cooperation with Uppsala University, Karolinska, and Skåne University Hospital, complete development of our platform and verify our technologies in lung-, prostate-, breast- and colorectal cancer.