Next-Generation Sequencing Takes Center Stage at Global Strategic Partner Summit

In the rapidly evolving field of precision oncology, it’s clear that no single entity will have all the answers to molecular-guided precision medicine. Meaningful progress will require extensive collaboration between private, commercial and academic players working together to improve patient care by leveraging the expertise of several stakeholders and advanced technologies such as next-generation sequencing (NGS).

To that end, Thermo Fisher Scientific hosted its inaugural Global Strategic Partner Summit on Oct. 2 in Boston with members of its Centers of Excellence program. Representing leadership from renowned university hospitals, academic research centers and large reference laboratories, the group convened to discuss ways to accelerate the adoption of – and reimbursement for – NGS in the clinic in an effort to help drive better and expedited medical intervention and patient care.

Collaboration between the Centers of Excellence and Thermo Fisher is pushing forward the ideals of precision medicine and helping global organizations harness the capabilities of NGS to improve cancer care. The program’s successful and ongoing growth was marked at the Summit with the announcement of the program’s expansion into the Asia-Pacific region with two new partners: Seoul St. Mary’s Hospital, part of Catholic Medical Center in South Korea, and Singapore General Hospital.

Highlighted by member presentations on the latest applications of NGS and several case studies in their respective regions, the Summit provided an overview of progress and impact NGS is having so far. The event also addressed hurdles that are continually being addressed, including the ever-changing reimbursement landscape in the U.S. While the U.S. Centers for Medicare & Medicaid Services (CMS) approved coverage for NGS as a diagnostic laboratory test in March this year, including Thermo Fisher’s Oncomine Dx Target Test, some payers still consider NGS explorative.

As some in attendance pointed out, CMS’s decision to support NGS is positive but reimbursement for hospitals with large privately insured patient populations remains important, although there are active options now in motion. While hospital administrators often go back to payers – sometimes more than once – to make the case for reimbursement, they are more regularly getting paid for NGS testing.

Globally, the reimbursement landscape varies greatly. In the EU, for example, each member state has its own policies. In India, as explained by Anuradha Chougule, Ph.D., professor and scientist, Department of Medical Oncology at Tata Memorial Hospital, many patients must pay for testing out of pocket. For this reason, smaller panels with less than 50 genes provide the best and most affordable option in the region.

While providers view NGS as a cost-effective and important diagnostic tool, those in attendance agreed that further education is needed to demonstrate the patient and long-term cost benefits of using a single, NGS-based test to simultaneously screen for multiple biomarkers. Late-stage cancer patients, with limited time to explore single-gene testing options to determine the best treatment regimen, are expected to benefit most with multi-gene NGS diagnostics.

Providers and heads of hospital laboratories also need to be educated, others said. NGS has become a routine part of cancer patients’ diagnosis and treatment planning at large academic medical centers, but 80 percent of cancer care is provided at community hospitals. These sites may not have the infrastructure to support NGS, or are unaware of the benefits associated with bringing NGS testing in-house to their institutions, as demonstrated by a recent paper published in the Journal of Clinical Pathology.

“There needs to be a change in the way the many caregivers think about NGS testing,” said Madhushree Ghosh, senior director of strategic accounts for Thermo Fisher. “It’s important that they understand NGS requires 10 times less sample and enables identification of comprehensive genomic data that can more effectively help direct medical care, as opposed to a single-gene testing approach.”

The impact of NGS can already be seen at institutions such as Children’s Hospital of Los Angeles, where its care team has sequenced nearly 500 pediatric cancer patients over the last year. In 30 percent of cases, the data has either led doctors to redirect their treatment plan or revealed additional information that changed the original diagnosis. NGS is also changing the way pathologists and oncologists work together as their conversations during regular tumor board meetings move toward one of deeper collaboration to determine the best treatment path for each of their patients.

“Next-generation sequencing information is changing the understanding of the disease, as well as the treatment and management,” said Tim Triche, M.D., Ph.D., pathologist and co-director of the Center for Personalized Medicine Program, Children’s Hospital Los Angeles, and professor of Pathology, Keck School of Medicine at University of Southern California. “Instead of just a written report, [oncologists] get to ask questions. We educate each other. Our dialogue with oncologists is at an intensity that I’ve never seen before, and they walk away with plans on how to manage their patients.”

Collaboration is a key tenet of Thermo Fisher’s Centers of Excellence program, which will continue to expand across the globe and align with leading stakeholders for the purpose of driving deeper adoption of NGS technology in clinical research, and broader implementation in the clinic.

“There is still a lot to do in precision medicine,” said Michael Hummel, Ph.D., head of Molecular Pathology, Charite Hospital. “If I do it in my lab alone, that’s not a good idea. If I do it alone with Thermo Fisher, it is significantly better. But when we have other partners, like pharma and oncologists, then we start to form a really good story.”