In just under 15 years, next generation sequencing (NGS) has evolved from a technology that only an exclusive few research laboratories had access to, to one in use by nearly 300 clinical laboratories worldwide.1,2
We're often approached by organizations that would like to start their own NGS testing program but some are concerned it’s too expensive, requires too many resources, or exposes their organization to risk when the return on investment is uncertain.
These are valid concerns that we feel compelled not to address. Instead, we’ll share what we hear from our customers and industry contacts about why they decided to insource all or a portion of their clinical NGS tests.
Here’s what they have to say:
“There is definitely a huge cost savings to our institution to conducting NGS testing in-house.” --Molecular Laboratory Manager, Academic Medical Center
By performing NGS tests in-house, rather than sending them out, most organizations realize a cost savings. We hear this often. In fact, one of our customers is a perfect example.
According to Dr. Eric Loo, Assistant Professor, Pathology and Laboratory Medicine at Dartmouth-Hitchcock Medical Center, his laboratory determined through a retrospective analysis of ~400 NGS tests for myeloid, lung cancer, and melanoma, that the hospital saved 77% in direct variable costs over what would have been spent had the tests been sent out. When considering labor and other fixed costs, the hospital saved 39%2.
For most laboratories, the cost-savings argument becomes even more compelling the higher the test volume is. If the tests are going to be ordered regardless -- why not run them in-house and save money in the process?
“We achieve fast, rapid turnaround time of results for patients.” --Laboratory Director, Academic Medical Center
Working to get answers back to patients as quickly as possible, laboratories do not want to be at the mercy of a third-party for turnaround time. In our customers’ experience, most NGS send-out tests have a turnaround time that exceeds two weeks, despite what a reference laboratory may publish. Turnaround time is important for all cancers, but especially for hematological cancers such as leukemia when patients are in blast crisis.
With the proper infrastructure and test protocols in place, laboratories can usually tighten turnaround time significantly. Case in point: One laboratory director we spoke with has set up reflex testing such that the NGS test results they run in-house are available within hours to a couple of days of the original biopsy. Another laboratory created a workflow for common cancers (particularly lung cancer) to enable pathologists to initiate NGS testing for standard of care biomarkers, decreasing the time to NGS results by 50% after diagnostic biopsy.
“By having in-house testing we've had better control.”
--Molecular Genetic Pathologist, Academic Medical Center
Workflow. Tissue. Data. Control over these components of an NGS test can significantly impact the quality of patient care, and ultimately affects the success of a hospital’s precision medicine program.
“One of the most impactful things providers can do,” commented a participant in a recent Association of Community Cancer Centers leadership summit3, “is to treat every cell of a patient as precious.”
With this goal in mind, one molecular genetic pathologist we talked with cited his laboratory’s ability to lower "quantity not sufficient" rates (QNS) to 2% overall by running NGS tests in-house. QNS rates of 20% are not uncommon for commercial reference laboratories, even reputable ones.
Intermountain Healthcare’s decision to insource4 NGS testing has allowed the health system to “control all genomic and associated data.” Data are the foundation of any precision medicine program. And by controlling the workflow, laboratories can use genomics data in a more meaningful way. This means integrating test results with clinical data, correlating somatic and germline findings, recruiting patients for clinical trials, or even building a compliant clinical repository to enable future research and the linking of variants with clinical outcome and drug response.
Having access to a patient’s medical record can also improve how genomic data are interpreted and ultimately how they are used to guide patient care. All of these efforts become more difficult when you outsource the tests and don’t have access to the underlying data.
“#1 benefit to insourcing is more efficient communication between pathology and oncologists.”--Laboratory Director, Medical Center
Many institutions recognize that precision medicine is changing the way that physicians work. As NGS tests become larger and more complex, and therapeutic options (on-label, off-label, and combination therapies) proliferate, collaboration between oncologist and pathologist in patient care is becoming increasingly important.
According to Thomas Brown4, Executive Director of Swedish Cancer Institute, NGS testing at Providence St. Joseph Health is “performed in-house, which allows oncologists to review and discuss the significance of genetic information directly with molecular pathologists.”
Pathologists are the doctor’s doctor. At times labeled “invisible” or “behind the scenes,”5 pathologists can in fact assume a very unique and pivotal role. Pathologists can work with the physician to determine the proper test for a patient, make recommendations on specimen acquisition, and have the specialized knowledge to interpret results.
Indeed, for many of our customers, running tests in-house has increased the collaboration between pathology and ordering physicians, which is a gift that keeps on giving: physicians continue to increase their knowledge of genomics, and pathologists gain more opportunities to collaborate with patients and physicians. None of this collaboration is possible when tests are sent outside of the organization.
“We want to continue to develop our expertise and remain competitive.” --Molecular Geneticist, Hospital Laboratory
For some laboratories, the decision to insource NGS testing is as simple as aligning with the mission of the larger healthcare organization. Many of the laboratories decide to bring NGS testing in-house in response to the organization’s objectives to build a precision medicine or more comprehensive cancer care program.
Growing expertise to support organizational objectives is evident in our work with customers; we can attest to this as we are seeing them do some remarkable work with clinical NGS. As a result, many of these laboratories want to leverage this expertise, and therefore it makes sense to find a way to cost effectively run the tests in-house.
Likewise, we hear from many other laboratories that they view implementation of this technology as critical to the success of their organization and want to remain competitive for two reasons: to offer the latest in testing technologies to their patients and to attract and retain the brightest staff.
Should Your Laboratory Insource NGS Testing?
While all healthcare institutions are different, one thing is clear -- the field is in transition, and we see laboratories in various stages of their adoption of clinical NGS. Through our interactions, we know that there’s not just one solution that’s appropriate for these labs, nor is it always appropriate to take an “all or nothing” approach. Many labs take a focused approach and continue to outsource tests while they bring online tests of their own and gradually build volumes. Likewise, some labs have found success by using a distributive model in which they can outsource test components to any accredited laboratory but still exercise dominion over the entire test.
As one of our customers said, the work required to insource clinical NGS “is nothing to sneeze at,” but it’s often much more doable than you might think. Community and expertise in this dynamic area is only growing, and we are here to lend a hand with educational materials and solutions that address your most vexing clinical NGS issues.
1.Crawford JM, Bry L, Pfeifer J, et al. The business of genomic testing: a survey of early adopters. Genetics in Medicine. 2014;16(12):954-961. doi:10.1038/gim.2014.60
2.PierianDx. CAP Distributive Model of NGS Testing.. PierianDx - Home. https://www.pieriandx.com/cap-distributive-model Accessed January 16, 2019.
3.Integration of Pathology in Oncology Care Leadership Summit. Association of Community Cancer Centers. July 31, 2018.
4. Naudald LD, Ford JM, Pritchard D, Brown T. Strategies for Clinical Implementation: Precision Oncology at Three Distinct Institutions.
5. Lopez JL. The Invisible Doctor. The Pathologist. https://thepathologist.com/outside-the-lab/the-invisible-doctor. Published July 15, 2016. Accessed January 17, 2019.