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Subspecialties Oncology, Precision medicine, Biochemistry and molecular biology

Biomarker Tests for Precision Oncology: DIY or Pay-for-Service?

sponsored by Thermo Fisher Scientific

When testing for cancer biomarkers, hospitals and healthcare systems must choose between developing in-house capabilities or purchasing outsourced services. But what’s best for the system – and what’s best for patients? To discuss this, we convened a panel of oncologists and pathologists with broad expertise in precision oncology biomarkers: Carl Morrison (Roswell Park Comprehensive Cancer Center, Buffalo, New York); Kojo Elenitoba-Johnson (Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania); Alain Mita (Samuel Oschin Cancer Center, Cedars Sinai, Los Angeles, California); and Wei Song (Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, New York). Moderated by Michael Schubert (Editor of The Pathologist) and Amy Carroll (Director of North America Medical Affairs, Next-Generation Sequencing and Oncology Division, Thermo Fisher Scientific), the panel explored the current state of biomarker testing – and the merits of keeping such testing in-house.

How does your institute organize precision oncology tests?

Carl Morrison: At Roswell Park, we perform mosts tests for our own patients; some are for outside parties, mainly local doctors.

Kojo Elenitoba-Johnson: At the University of Pennsylvania Health System, we also focus mainly on our own patients. We opt for in-house testing wherever possible; that said, some tests must be outsourced.

Alain Mita: At Cedars Sinai, we use both in-house and outsourced testing.

Wei Song: At Weill Cornell, in-house is the default.

What are your thoughts on centralized versus in-house testing?

WS: I believe that in-house molecular diagnostics capability is indispensable – no pathology practice is complete without it. Furthermore, in-house expertise is vital for educating future residents. Finally, inhouse facilities better meet oncologists’ needs regarding type and size of assay panel – and, in particular, turnaround time. Our clinicians’ top priority is rapid assay of 20–30 variants for immediate input into clinical management. Speed is key!

Doctors want fast results for that subset, not slowly delivered data for every single marker of potential interest.

CM: Agreed; up to 98 percent of clinical decisions are based on a small subset of biomarkers. Doctors want fast results for that subset, not slowly delivered data for every single marker of potential interest. It’s true that in-house laboratories may not be able to duplicate the infrastructure found in a commercial institution performing thousands of tests annually – but, when turnaround time is key, in-house is better. Remember, it can be time-consuming to transfer clinical samples, such as bone marrow biopsies, from hospitals to central laboratories.

AM: Yes – the logistics of sample transfer is a critical point, because doctors need assay data as early as possible in the clinical management process. In lung cancer, for example, the best outcomes require mutation-specific therapy. And initial therapy choices may have big impacts – immunotherapy followed by mutation-targeted therapy gives more severe side effects than the converse. Rapid decision-making also helps patients psychologically. After diagnosis, they want to start treatment as fast as possible, so turnaround time is of the utmost importance. Another advantage of in-house testing is that physicians can access their molecular pathology departments for expert advice. Because assay interpretation can be difficult, even for those familiar with molecular testing, this is an important advantage that centralized laboratories cannot offer.

KEJ: Three parameters influence the in-house versus outsourcing decision. First, the nature of the institute’s patients; why invest in a test if its patients don’t need that test? Second, infrastructure and capital expenditure considerations; building next-generation (NGS) capability requires hardware, software, trained personnel, and regulator-acceptable systems. Finally, bottom-line factors such as reimbursement also influence an institution’s precision diagnostics strategy. In some cases, outsourcing may alleviate patients’ cost burden. In others, patient volumes may affect the bottom line; if few patients need a given test, offering it may not be cost-effective. That said, there are often trade-offs between the cost advantages of outsourcing and its slower turnaround time.

WS: Another point: in-house facilities help oncologists to better serve patients. For example, if we have insufficient material for the assay – which does happen – we can simply ask for more.

A key advantage of in-house testing is collaborative decision-making.

Can in-house testing promote team-based coordination of patient care?

AM: Yes. A key advantage of in-house testing is collaborative decision-making. As a clinician, I place a high value on interactions with molecular pathologists. These range from phone calls and emails regarding urgent decisions to molecular tumor boards where we discuss complex cases that benefit from a variety of expertise.

WS: I agree. I regularly discuss data interpretation with my oncologist colleagues. For example, in complex cases – such as patients with two targetable molecular drivers – we employ methods to identify the dominant driver and design more effective care. It’s all about patient benefit.

CM: The in-house environment also enables interactions with medical directors and payers. A phone call to discuss the situation can help to prevent a patient’s treatment being denied. By contrast, centralized routes involve large, impersonalized systems; interaction is difficult and patients may be denied out-of-pocket costs.

KEJ: These discussions also benefit primary care providers, not just those at the tertiary center.

Are all tumor boards becoming molecular tumor boards?

KEJ: In our center, yes. And, in my experience, the molecular tumor board often extends across institutional boundaries. For example, the referring institution or academic institutions may be included, often via telemedicine systems. I believe the reach of the molecular tumor board will continue to grow. After all, there is a natural synergy between oncologists, pathologists, and genomicists.

WS: I’m not so positive about separate, dedicated molecular tumor boards – but I do like the idea of integrating genomic profiling into routine tumor boards. Outlining translation pathways and available targeted therapies is very helpful for oncologists.

AM: Identification of clinical trials that may address a patient’s mutation profile is also extremely helpful; molecular tumor boards can provide this information as well. The only problem is that you can’t have such meetings in real time; they can take a couple of weeks to set up. But, in the future, I anticipate that most discussions will be integrated into these tumor boards.

What should we aim for in terms of communication speed?

CM: Molecular pathology laboratories should get reports back to oncologists within six days – preferably three or four. Ideally, structured data should be uploaded into the electronic health record as it becomes available, even if the complete report is not ready. And the lab should answer queries very rapidly – certainly within 24 hours.

KEJ: I completely agree. We must deliver accurate, clinically relevant results on a timescale that is relevant to the patient’s treatment. But turnaround speed depends on a large number of factors, many of which are somewhat institute-specific. The ability for clinicians to follow-up is also important.

How is precision oncology testing evolving?

CM: Molecular pathology in Roswell Park began about 15 years ago with single-gene tests and advanced to NGS in 2012. Our in-house panels became the basis of a spinout venture in 2015 – and now we are broadening our inhouse capabilities again, including new NGS tests.

KEJ: We have gone from classical cytogenetics to NGS. For the last six years, all such tests have been performed in a single division comprising both scientists and clinicians with subspecialty certification from the American Board of Pathology and Molecular Genetic Pathology. The test volumes rise each year, as does the range of assays – it only takes one peer-reviewed publication to add to the list of genes relevant to precision oncology! At the same time, we vary the tests we perform according to the nature of the patients we treat and the turnaround times of the platforms we use. Accordingly, we remain dynamically reactive to the changing biomarker assay environment. More broadly, we expect that, in the near future, any pathology lab will be able to profile the key subset of predictive biomarkers. After all, WHO guidelines now recommend molecular testing to support diagnosis of many cancers. The future is molecular!

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