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Diagnostics Genetics and epigenetics, Omics, Oncology, Precision medicine

Let’s Do It Ourselves

sponsored by Thermo Fisher Scientific

Over the last decade, precision oncology therapies dependent on biomarker-based diagnostics have proliferated. The personalized nature of these new treatments, which often exploit the specificity of the immune response, bring hope to many oncology patients. But medical advances typically raise practical questions even as they provide therapeutic answers – and the rise of molecular pathology is no different. Although still relatively new, this field is rapidly progressing – no longer just the province of academic medical centers, but a recognized discipline on its way to becoming routine practice. And this evolution is generating decision points for healthcare providers: not least, whether to outsource biomarker testing to centralized laboratories or implement it in-house. What is best for the system – and what is best for patients?

Remarkably, our thought leaders all agreed that in-house biomarker testing, as opposed to outsourced testing, is associated with key benefits.

This debate is vital for the future of both molecular pathology and the patients themselves. Therefore, during 2020, we hosted a virtual panel debate (now available to view on demand) and conducted a series of interviews with experts in the field. Each of these individuals brought their own unique perspective and experience, but all were united in their passion for patient care and for molecular pathology; it has been a privilege to listen to them. Furthermore, it has been fascinating to observe the concordance between independent experts working in different parts of the world, under different healthcare systems. Remarkably, our thought leaders all agreed that in-house biomarker testing, as opposed to outsourced testing, is associated with the following key benefits:

  1. Time savings: this in turn permits faster and more optimized treatment decisions. 
  2. Biopsy economy: this “tissue saving” allows additional future tests to be performed if required. 
  3. Improved coordination of patient care: this is particularly important in the context of multidisciplinary teams and supports the delivery of flexible, truly personalized medicine. 
  4. Development of local expertise: this is essential if biomarker-driven precision medicine is to reach its full potential.

Below, we provide some key expert insights, which represent a shared consensus view held by all our interviewees, irrespective of their nationality or the healthcare system that employs them.  

Alain Mita, Medical Oncologist, Co-Director of the Experimental Therapeutics Program, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai, Los Angeles, California, USA

Turnaround time is one of the big advantages of inhouse testing. I recently had an elderly patient with lung cancer who was not a candidate for chemotherapy, so we needed to decide between immunotherapy and targeted therapy. We didn’t want to make the wrong decision, because the sequence of treatment matters; the risk of side effects from targeted therapy is much higher after immunotherapy. The decision had to be made quickly, so we did an in-house panel and chose a treatment right away. I don’t know what would have happened if we had waited three weeks for results from a central lab.

Tanya Ahmad, Consultant Medical Oncologist, London, UK

Delays in availability of test results are potentially clinically harmful, especially for lung cancer patients, who often present in the advanced stages of disease and with comorbidities that affect their suitability for treatment. Also, an inadequate test result or a lost sample could be the difference between starting treatment within days or within weeks – and, because patients need to be relatively fit for certain therapies, rapid deterioration can mean they miss the opportunity for treatment entirely.

Michael Vieth, Professor of Pathology, Chairman of the Institute of Pathology, Klinikum Bayreuth, Germany

When a clinician asks us to perform a specific test, our first step is always to identify the most suitable methods. By carrying out all testing in-house, we can adjust these methods to best suit each individual sample while maintaining regular communication with our clinicians to align testing with clinical needs. This benefits the patient because we can provide the treating oncologist with an immediate response, asking for further samples or information if necessary.

Fernando López-Ríos, Director of Pathology and Targeted Therapies Laboratory, Hospital Universitario HM Sanchinarro, Madrid; Professor of Pathology and Molecular Pathology, Universidad CEU, San Pablo, Spain

It is important to preserve as much as possible of the precious patient biopsy samples. If you do your testing in-house, you can decide on the test flexibly, based on amount of sample available. By contrast, the centralized labs perform the same large test (a panel of over 500 genes) on all samples, and sometimes do not get any result due to insufficient tumor material. This can result in delays and possibly re-biopsies.

Rui Manuel Reis, Coordinator, Molecular Oncology Research Center, Barretos Cancer Hospital, Barretos, São Paulo, Brazil

In-house testing allows us to discuss results with clinicians during meetings of multidisciplinary tumor boards. This helps them better understand the findings, ask questions, and plan the best treatment for each patient, ultimately leading to better care and outcomes.

Wei Song, Director, Clinical Genomic Laboratory, Englander Institute for Precision Medicine; Assistant Professor of Pathology and Laboratory Medicine, Weill Cornell Medical College; Assistant Attending Pathologist, New York-Presbyterian Hospital, New York, USA

We regularly participate in multidisciplinary tumor boards and have numerous telephone conversations with clinicians. This level of interaction is not possible when sending out tests to a central lab. Furthermore, my experience of communicating with central labs is that the people I speak to usually are not trained pathologists and lack the expertise to address my questions.

Ruthy Shaco-Levy, Professor, Head of Pathology, Soroka Medical Center, Clalit Health Services; Head of the Israeli Pathologists Association, Beer-Sheva, Israel

Pathology departments not using these techniques will be left behind, so pathologists must develop expertise with the new testing methods, and with molecular pathology in general.

Pathology is one of the fastest-developing fields in medicine, and molecular pathology is one of the fastest developing areas in pathology. Soon, molecular pathology will likely be routine for confirming the diagnosis and prognosis of most tumors. Pathology departments not using these techniques will be left behind, so pathologists must develop expertise with the new testing methods, and with molecular pathology in general. 


Complete interviews are available as a free e-book: www.oncomine.com

www.oncomine.com

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