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Microfluidics-Enhanced Circulating Tumor Cell Separation Towards Liquid Biopsy Cancer Diagnostics

Microfluidics-enhanced circulating tumo cell seperation towards liquid biopsy cancer diagnostics - Microfluidics Innovation Hub and Cellway

Interview: Dr. Özge Zorlu

Co-Founder & CTO, Cellsway

In our exclusive Q&A with Dr. Özge Zorlu, he introduces us to his company Cellsway, talks about the project with the MIH and shares insights into their experience with the Open Call.

Could you tell us more about Cellsway and what the company does exactly?

Cellsway is a deep-tech university spin-off providing innovative solutions to unmet needs in the field of cancer through its IP protected liquid biopsy platform. Cellsway seeks to exploit the potential of Circulating Tumor Cells (CTCs) for personalized medicine and to help clinicians with therapy guidance/monitoring using its proprietary microfluidic technology and user-friendly instrument in combination with a portfolio of downstream assays. We stand out among the competition with (i) Patent-protected microfluidic technology for enriching CTCs from blood in an epitope-independent fashion with high recovery and high throughput without damaging the viability and intactness of the cells. (ii) Outstanding interdisciplinary R&D team and know-how (iii) Unique business model incorporating CTC-based assays together with CTC enrichment technology, forming a complete workflow and clinically actionable output. We currently running a 300-patient clinical performance evaluation study in collaboration with four hospitals on breast, prostate, and colorectal cancer.

Our front-end customers are clinical service laboratories and CLIA laboratories, through which the assay results will be available to oncologists and pathologists. Our products are as well usable in cancer and pharma research for drug development and efficacy analysis studies for personalized medicine. We recently signed our first commercial agreement with a service laboratory in Turkey and currently we are focused on extending our customer and collaborator portfolio in US and Europe.

How did you find out about the MIH and the Open Call?

We found out about the MIH through one of the consortium members that we wanted to work with on polymer chip manufacturing.

What made you interested in applying to the Open Call?

The one-stop-shop solution and the financial contribution of the European Commission motivated us to apply for the Open Call. The manufacturing service that we are seeking require different expertise (ISO 1385 compliant chip manufacturing line, microfluidic channel surface treatments, microfluidic interfacing, and chip packaging) from different fields. Without a consortium such as the NGM, we would have to manage all the communication between separate parties, which would certainly be a cumbersome process.

How did you find the application process? What specific criteria did you have to meet to receive funding?

The application process was detailed but smooth. We had several meetings with all the NGM consortium partners and fine-tuned our requests and related specifications. Then, we formed a “Concept Paper” based on this conversation and submitted to NGM. There were several gating mechanisms that we were able to walk through easily, thanks to the feedback of the MIH team during the preparation process.

For the successful acceptance of our proposal, we worked on the technical challenges to be solved together with the consortium, as well as the commercial impact of the project and our definition of a successfully implemented project.

Can you very briefly describe the problem you introduced to the Open Call and how the MIH members address it?

There were several bullet points that we targeted to address in the frame of this project:

  • Transfer to polymer: Transition from MEMS-based process to polymer manufacturing while keeping the geometry of the microfluidic channel as much as possible. This transfer enables higher volume manufacturing and cost reduction in the unit chip price.

  • Surface functionalization: The channel surface should be coated with a biocompatible material that prevents biofouling. This process needs to be integrated to manufacturing for a better user experience: less complicated protocol and shorter operation time. The shelf life of the coated material is also critical in this case.

  • Chip packaging: Polymer microfluidic chips are disposable and single use. Therefore, a cost-efficient and dust-free packaging for each individual chip is required.

  • Microfluidic interface: The microfluidic interface should be compatible with the Cellsway instrument and help mount/unmount the chip in a user-friendly and quick way.

  • ISO 13485 compliant manufacturing process: The manufacturing should be done under ISO 13485 quality system for upcoming regulatory pathway such as CE-IVD marking and FDA registration.

Most of the discussions were on the selection of the correct manufacturing process, aligned with the technical specifications we seek, target unit cost, and throughput. The NGM consortium has several companies with polymer manufacturing capabilities with different techniques. Therefore, we had the chance to discuss all the options and the consortium partners were able to offer us the best alternative. The other bullet points to be resolved were rather simpler as the consortium had to-the-point expertise on these.

What does the program specifically provide you, which you would not have achieved independently?

Selection of the manufacturing technique: We were able to discuss together with all the manufacturers offering different methods. This led us elaborate on the manufacturing process in a very detailed way and with many aspects including throughput and cost as well as technical features. We had honest feedback from each service provider and came to a mutual agreement on the manufacturing technique.

Integration of the surface coating protocol to manufacturing: We had the opportunity to work with three providers in coherence on a relatively complicated task, which would otherwise be very difficult to realize and maintain.

The MIH inctroduced your problem to its 20 members whose capabilities and expertise cover the MFC valuechain, what is your view on accessing a wide diversity of services through a single entry point?

We believe this approach significantly helps ideas and prototypes to transform into successful products. We see mutual benefit on this approach, such that customer companies like us have the chance to establish their supply chain in a cost-efficient way, some have the chance to solve a specific problem out of their expertise area. On the other side, the consortium members have the chance to connect with companies, which in the future will potentially be their customers.

How do you feel about the current state of your project with the MIH?

Currently we are attacking the technical challenges to be solved in the course of the project and up to now we had significant progress. We are very excited to progress further and achieve the goals of the project and have our pilot manufacturing and chips ready for mid-high-volume production.

What are your plans after the program, how will you utilize the results?

Depending on the results, we hope to see the consortium members of the program become our service providers for the high volume manufacturing of our chips.

Would you recommend companies similar to Cellsway apply for the Open Call?

Yes, I recommend the Open Call to SMEs that have a minimum viable product and ready to take the next step for scaling their manufacturing and SMEs that are seeking a specific expertise to complement their products to step forward in the competition.

DOWNLOAD the data sheet to find out more about the project:

Reference Case_Cellsway
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