With the number of treatment options constantly increasing, more frequent monitoring helps the oncologists to respond more quickly in case the treatment is not satisfactory, or a drug resistance is induced. As a result, the patient will receive efficient treatment faster. Cancer medications are often expensive and predicting the effect could be hard, but they can also have the potential to completely cure the cancer. That is why it is important to find the correct medication right as soon as possible. Therefore, screening for cancer with BiopSense is an effective way to improve the quality of cancer treatments and to reduce the burden of cancer.

a great technology with practical challenges

• Blood-based diagnostics can improve oncology and prenatal screening
• Sample logistics problems reduce method sensitivity
• 61% of studies call for improved sample processing*

Liquid biopsy (LB) diagnostics can improve cancer treatment monitoring and personalization. There are currently pre-analytical challenges, which include 1) the need for skilled personnel to perform sample preparation, and 2) strict logistic requirements for sample transportation, often overseas. In the current LB workflows, plasma separation includes two critical centrifugation steps either at the sample collection site or in the clinical laboratory.

If the sample is prepared on-site, a dry-ice shipment is required. Alternatively, transportation of the sample as blood is complicated by the need for fast and temperature-controlled shipment, as the release of nucleic acids from white blood cells would destroy the LB sample.

Overall, manual preparation of plasma leaves the current process vulnerable to human errors and therefore an automated, standardized technology for plasma separation, DNA extraction, and quantitation is required.

cfDNA

Cell-free DNA (cfDNA) allows non-invasive analysis of cancer-causing genetic mutations. The low amount of cfDNA circulating in the blood of a healthy person originates from apoptotic blood cells. However, in case of cancer, tumour tissue is shedding short circulating tumour DNA (ctDNA) fragments, dependent on the tumour location and volume.

In our experience with ctDNA, mutated cancer DNA varies between 0.1-60% of the cfDNA of cancer patients. Measuring the amount and genetic/epigenetic changes in the ctDNA is a potential tool for determining the origin and the burden of cancer and capturing new mutations appearing during targeted therapies. So far, the access to this rich genetic and epigenetic information available in ctDNA has been prone to errors due to variable amounts and quality of the input material for analysis. The variation in sample quality can result from interfering genomic DNA, which is thousand times more frequent than cfDNA in the blood.

*[1] https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.e14529 [2] An internal review of 150 liquid biopsy studies, 2023

Our invention is an automated device (cartridge) for cell-free nucleic acid extraction from large blood volumes (up to 10 ml) in less than an hour without the need for centrifugation or other manual steps.

Automating a process that currently involves lots of human labour

Sample transfer is a challenge for the global availability of liquid biopsy diagnostics. We are developing an automated extraction and transfer cartridge for blood-based biomarkers (DNA, RNA, cells, proteins) to better support frequent sample acquisition and analysis. Our goal is to facilitate the expansion of the global liquid biopsy diagnostics across borders and continents, independent of the laboratory workforce situation at the sample collection site or of the conditions of the sample transfer.

Advantages of our cartridges:

• Minimal training requirements
• Low initial investment
• One minute hands-on time
• Built-in QC
• Excellent yield and quality
• Stabilized sample for shipping
• Applicable in any healthcare setting

At BiopSense we have a passion to help cure cancer. Early detection and accurate treatment are the key steps to accomplish thig goal. BiopSense is MedTech company founded in Finland and was born from a research project at the University of Jyväskylä. We have a diverse and committed core team with extensive expertise from nanoscience to oncology. We co-operate with EIC European Innovation Council, Business Finland and Startup Factory of Jyväskylä. Please feel free to contact us if you are interested in hearing more.