Driving Forward Companion Diagnostics Development

Last month, the Institute of Medical Genetics and Pathology at University Hospital Basel became the first partner in Thermo Fisher Scientific's Next Generation Sequencing Companion Dx Center of Excellence Program. The program aims to drive forward the development of companion diagnostics such as NGS-based assays for oncology, to ultimately lead to personalized medicine and improved patient care.

To find out more about the motivation behind creating the program, and the expected benefits it could bring, we spoke to Mark Stevenson, President of Life Sciences Solutions for Thermo Fisher Scientific.

AM: Can you tell us a little about the NGS Companion Dx Center of Excellence Program? What was the motivation behind creating the program?

MS: The Center of Excellence Program is a new initiative designed to develop and refine Thermo Fisher’s NGS-based research assays from its Oncomine oncology portfolio with the intent to eventually introduce them into the clinic as companion diagnostics. Thermo Fisher has had long relation with the Institute of Pathology at University Hospital Basel. So to expand the relationship, we mutually decided to formalize our interaction through the Center of Excellence (COE) program. 

As a key opinion leader, we believe the University Hospital Basel and the COE will one day help influence guidelines and the decision-making processes within European Union countries from a reimbursement and patient-care perspective. As leaders like University Hospital Basel adopt new technologies, so may others in the region.

AM: What benefits do you expect the program to bring to patients and the clinic?

MS: The Center of Excellence program is focused on developing new and existing technology designed to one day improve patient care in oncology. The Oncomine products currently being further developed for the clinical include our liquid biopsy and immune response assays, as well as others.

Our collaboration through the Center of Excellence program provides us valuable guidance and direction on how to develop these products in a way that will be most useful to the hospital for eventual application in patient care. This teamwork also significantly reduces our product development time so that the expected improvement to patient care can one day be delivered more quickly by University Hospital Basel and groups like it.

AM: Are there any hurdles that need to be overcome when introducing NGS assays to the clinic?

MS: Regulatory guidelines are different in the European Union than in the United States. Clinical trials are also run differently in each region, but it’s not necessarily a hurdle. It’s just a process that takes time and investment to complete.

Next we spoke to Dr. Markus Tolnay, Manager of the Institute of Medical Genetics and Pathology, University Hospital Basel, to learn more about the Institute's involvement in the program and how he thinks it will help to improve the future of patient care.



AM: Can you tell us about your involvement in the Center of Excellence Program?

MT: Our Institute currently uses high throughput NGS (next generation sequencing) as the method of choice for routine molecular testing of cancer patients. Having sequenced more than 5,000 samples using the IonTorrent NGS technology over the past few years in Basel, we have accumulated substantial knowledge about this method. In particular, we specialize in the headlining and analysis of limited material from FFPE (Formalin Fixed Paraffin Embeded) tissue, from both biopsy and cytology specimens. Being inspired to push the boundaries of our field, along with Thermo Fisher, we strongly engaged our Molecular Diagnostics Team to improve already commercialized NGS-related solutions (e.g. Ion Reporter), as well as in participating in early access customer programs (e.g. Oncomine family of products). The open, encouraging and transparent communication with Thermo Fisher has proven to be exceptionally positive. Based on such an exciting experience, we eventually jointly agreed to reinforce our partnership by participating in the Centre of Excellence Program.

AM: How will the program help to improve cancer patient care?

MT: Improving cancer patient care represents the driving force of our engagement with Thermo Fisher. We aim to achieve such challenging goals such as introducing new solutions for routine molecular profiling of cancer samples, validating panels for currently poorly covered area of oncology (e.g. Sarcoma, CNS tumors, etc.), or by ameliorating current bioinformatic algorithms for complex genomic rearrangement calling.

Having better-performing assays will lead to higher quality of data. This will allow accurate genomic-based patients’ stratification, eventually enabling Precision Medicine to spare unnecessary treatments, reduce side effects and obtain a superior clinical benefit.

AM: What role do you see companion diagnostics playing in the future of healthcare?

MT: In my view, companion diagnostics will play a pivotal role in enabling Precision Medicine in the near future. Pharma companies have learned that no drug fits all tumor subtypes, and only via an accurate definition of the tumor genomic landscape one can define the best therapeutic treatment option. Defining patients’ subgroups, as classified by using companion diagnostics, will lead to more effective clinical advantages. I envision the majority of future targeted therapy approaches to be developed along with meaningful companion diagnostic solutions. 

Dr. Tolnay and Mark Stevens were speaking to Anna MacDonald, Editor for Technology Networks.