Background
FADEQ has its roots in ERC PoC project BiopSense, which developed a point-of-care genetic analyser for liquid biopsy diagnostics. The key outcome of the project was a method to ensure plasma quality in hospital setting, where samples are not collected in batches, but one by one. To apply the technology in a relevant environment, the team established the BiopSense service laboratory. Now, BiopSense has obtained next level funding through the Horizon Europe EIC Transition Grant to continue developing FADEQ technology and improve market readiness.
Problem worth solving
Liquid biopsies (LB) are minimally invasive (e.g. blood) tests for diagnostic purposes. Examples of LB include genetic diagnostics for cancer, but also prenatal screening and biomarker studies for cardiological and metabolic diseases. LB diagnostics are limited by pre-analytical challenges, which include
1) the need for skilled personnel to perform sample preparation, and
2) strict logistic requirements for sample transportation.
In current LB procedures, separation of the plasma includes two critical centrifugation steps of the blood either in the sending hospital or in the central laboratory. If the sample is pre-processed on-site, melting of the frozen plasma or cfDNA during the transport is detrimental. Alternatively, transportation of the material as full blood is complicated by the need for fast and temperature-controlled shipment, as the release of nucleic acids from lysed white blood cells would destroy the LB sample. Overall, collection of plasma by hand makes the process vulnerable to human errors and therefore an automated, standardizable technology for plasma separation, DNA extraction, and quantitation is required. Currently, there are no commercialized solutions to avoid the centrifugation steps for isolating plasma from blood and for automation of the complete process.
The Solution
FADEQ develops a fully automated sample processing cartridge for the purification and transfer of biomarkers (DNA, RNA, cells, proteins) in blood samples. This allows for more frequent collection and analysis of samples, regardless of the laboratory workforce in the hospital or health center. The technology can enable more reliable and feasible procedures for repeated liquid biopsy analyses and also opens up opportunities for expanding the fluid biopsy service business internationally. Allowing real-time patient screening, FADEQ could allow optimizing modern cancer treatments, such as targeted and immuno-oncological treatments.
Markets
The global liquid biopsy market forecast looks promising, expected to reach Eur 5.7 billion in 2028 with a CAGR of 20.9% from 2021 to 2028. US is much ahead of Europe in investments in the LB business, being at the very early stage of market development. The major drivers for market growth are the rising prevalence of cancer, the preference for non-invasive procedures and the importance of early detection of diseases in cancer outcomes and medical expenditure.
Customers
Customers will include biotechnology companies, diagnosis laboratories and hospitals, with a special focus on cancer diagnosis and oncology departments.
Competitive advantage
weakest and the most vulnerable link, requiring standardization. FADEQ enables safe transfer of the purified cell-free DNA (and RNA) to a diagnostic service provider over regular mail. The method enables immediate sample processing and provides an encapsulated, stable, concentrated nucleic acid sample, which tolerates all transport conditions, including freezing and heat. In addition, constant cfDNA yields up to 40% higher than by standard centrifugation can be obtained due to an additional rinsing of the sample.
Team
FADEQ is developed by spinoff company Biopsense Oy, which started from a research project at the University of Jyväskylä. BiopSense currently has revenues of nearly 3.6M€ from its clinical laboratory services.
