Commentary
Jeffrey G. Jones
October 2026—Innovation in molecular diagnostics remains essential, yet the competitive advantage appears to be shifting from invention alone to execution.
The organizations most likely to shape the next generation of laboratory medicine may not be those that simply develop the most innovative technologies. Instead, it is likely to be those that can generate the evidence, secure the reimbursement, achieve the adoption, and scale the commercialization that are required to translate innovation into routine clinical practice.
This view was reinforced in discussions during and after the ASCO meeting this year with laboratory executives, reimbursement leaders, investors, oncologists, and pathology stakeholders, some of whose comments are shared here, and it is spoken of throughout the diagnostics industry.
Increasingly, the organizations most likely to succeed may be those that can integrate scientific innovation, evidence development, reimbursement strategy, operational
scalability, and commercialization execution over extended time horizons.
Molecular diagnostics in the past decade has undergone one of the most remarkable periods of scientific innovation in modern health care. Next-generation sequencing, liquid biopsy, AI-driven pathology, multi-omics, and precision oncology have transformed what is technically possible inside the clinical laboratory.
At the same time, the industry itself appears to be entering a new phase of maturation. Historically, the most durable diagnostics markets ultimately developed commercially sustainable delivery models capable of supporting broad clinical adoption. In traditional in vitro diagnostics markets, this often involved standardized testing performed across hospital and regional laboratory networks. In molecular diagnostics, however, the emergence of high-complexity laboratory-developed tests enabled highly centralized reference laboratory models that have remained dominant across many segments of the market. Whether portions of liquid biopsy and other measurable residual disease testing and multicancer early detection remain centralized, become more broadly distributed, or evolve into hybrid delivery models remains uncertain.
Despite this extraordinary scientific progress, many laboratories continue to struggle to achieve durable commercial adoption of their technologies.
The challenge facing CLIA laboratories is no longer innovation alone. The greater challenge is operational execution: reimbursement, evidence development, commercialization strategy, regulatory alignment, and long-term financial sustainability. And the disconnect between innovation and execution appears to be widening across the diagnostics industry.
Abbott’s recent acquisition of Exact Sciences for approximately $21 billion may further reflect how the diagnostics industry itself is evolving. Increasingly, the strategic value may lie not only in the underlying assays or technologies but also in the evidence infrastructure, reimbursement positioning, operational scale, physician access, and commercialization capabilities required to support durable clinical adoption over extended time horizons.
Many founder-led laboratories and early-stage diagnostic companies still follow a familiar sequence: develop the assay, validate the technology, launch the laboratory-developed test, and then begin thinking about reimbursement strategy. Historically, that model may have been sufficient in portions of the molecular diagnostics market. Today, it is not.
In the current reimbursement environment, particularly within advanced molecular diagnostics, reimbursement strategies often influence assay architecture itself. Validation design, intended use, coding strategy, clinical utility endpoints, operational scalability, and commercialization planning need to be considered in parallel with assay development rather than after the fact.
This shift has become particularly visible within liquid biopsy and other oncology testing. Scientifically, the innovation has been extraordinary. Commercially, however, even some of the industry’s most heavily funded and technically advanced companies continue to face lengthy evidence-generation cycles, evolving payer expectations, and extended reimbursement timelines before broad clinical adoption can occur.
David Harding, SVP of pipeline product management at Exact Sciences, now Abbott, described the challenge succinctly: “Ultimately, it’s about the math.” As diagnostics move toward large population screening applications, particularly within multicancer early detection (MCED), demonstrating clinical utility often requires extraordinarily large and expensive clinical studies involving tens of thousands of patients. Generating the evidence required to support adoption, reimbursement, and guideline inclusion becomes the defining factor separating promising technologies from durable commercial successes.
MCED testing may now represent one of the clearest examples of the growing disconnect between scientific innovation and commercial execution across molecular diagnostics. Companies such as Grail with Galleri, Abbott with Cancerguard, and others have helped accelerate investor enthusiasm and broader market awareness surrounding blood-based multicancer screening technologies.
Scientifically, the progress has been extraordinary. Yet despite substantial investment, extensive clinical studies, and rapid technological advancement, broad reimbursement and clinical adoption remain largely unresolved. Grail, for example, currently markets Galleri primarily as a cash-pay offering priced at about $949 out-of-pocket despite significant market visibility and years of evidence generation.
Grail’s January 2026 premarket approval application submission for Galleri to the Food and Drug Administration represents a major milestone for the broader MCED industry. Supported by extraordinarily large clinical studies, including PATHFINDER 2 and the NHS-Galleri trial, which involved more than 140,000 participants in the United Kingdom, the submission represents one of the FDA’s first attempts to evaluate population-scale multicancer blood screening. Importantly, the FDA’s review extends well beyond analytical performance alone. Clinical utility, false-positive rates, downstream diagnostic workups, health care economics, and overall population-level benefit become central determinants of regulatory approval and eventual clinical adoption.
The February 2026 enactment of the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, establishing a Medicare coverage pathway for FDA-approved MCED tests, is another important milestone for the industry. However, the legislation should not be interpreted as automatic reimbursement. The Centers for Medicare and Medicaid Services and commercial payers will still require substantial evidence demonstrating clinical utility, economic value, and appropriate integration into clinical workflows before broad coverage and adoption occur.
Beyond reimbursement, achieving inclusion in National Comprehensive Cancer Network and other clinical practice guidelines often represents another critical execution milestone. Richard Bender, MD, practicing oncologist and former medical director at Quest Diagnostics, said physician adoption ultimately depends on evidence generation and guideline inclusion. “The NCCN guidelines have become the go-to reference for practicing oncologists and often determine whether a new molecular diagnostic test becomes part of routine clinical practice,” he said.
In many respects, MCED highlights how the diagnostics industry itself has matured. The challenge is no longer simply developing the technology. It is sustaining the time, capital, evidence generation, reimbursement strategy, operational scale, and commercialization execution required to achieve durable clinical adoption.
These realities are not unique to MCED. Evidence generation, reimbursement, physician adoption, and guideline inclusion, across molecular diagnostics, are increasingly determining which technologies achieve durable commercial success. Mark Straley, CEO of Agendia, said, “You don’t really have a business until you’ve generated sufficient evidence to drive physician adoption and guideline inclusion. That process often takes seven to eight years or longer and far exceeds what many companies initially anticipate.”
Liquid biopsy and other measurable residual disease testing further illustrates how molecular diagnostics is evolving beyond scientific innovation alone. Advances in next-generation sequencing, ctDNA detection sensitivity, and tumor-informed assay design have transformed what is technically possible in oncology diagnostics.
Companies such as Natera with Signatera, Guardant Health with Guardant Reveal, Exact Sciences, Personalis, Tempus, and others have helped accelerate investment and clinical interest across the MRD landscape. Portions of the category have already begun achieving meaningful reimbursement traction. Natera’s Signatera, for example, has secured Medicare coverage across multiple oncology indications, with reimbursement rates approaching about $4,000 per test in certain covered settings. Other MRD assays have similarly secured MolDx coverage in select colorectal cancer surveillance applications.
Despite this progress, much of the expanding solid tumor measurable residual disease testing market continues to operate primarily through advanced LDT models. In part, this reflects the significantly greater biological and operational complexity associated with solid tumor MRD testing itself. Many current approaches remain tumor-informed, requiring an initial tissue biopsy and individualized assay development based on the patient’s unique tumor signature. While these approaches may offer important analytical advantages in certain settings, they also introduce additional challenges for workflow, scalability, turnaround time, tissue acquisition, and longitudinal monitoring.
Competition within MRD testing is no longer centered on analytical sensitivity or technical differentiation. Rather, reimbursement strategy, evidence generation, pharma partnerships, operational scalability, physician adoption, and payer access are becoming equally important competitive factors. The strategic importance of MRD testing is also reflected in broader industry consolidation activity, including Quest Diagnostics’ acquisition of Haystack Oncology, highlighting the growing value placed not only on assay performance but also commercialization infrastructure, payer access, and scalable distribution.
As Eric Vail, MD, director of molecular pathology at Cedars-Sinai Medical Center, said, “I’m willing to sacrifice cutting-edge capability for stability. In a clinical laboratory, consistency and reliability often matter more than being first.” His observation highlights another often-overlooked reality of adoption: Laboratories must balance innovation with workflow integration, operational performance, and the risks of implementing rapidly evolving technologies.
In many respects, MRD testing reflects how the diagnostics industry itself is maturing. Technically strong assays alone are no longer sufficient to guarantee durable commercial success. Increasingly, the organizations most likely to succeed may be those that can integrate scientific innovation, evidence development, reimbursement strategy, operational scalability, and commercialization execution over extended time horizons.
At the same time, the broader operating environment for laboratories has grown more complex. MolDx technical assessment expectations continue to evolve. Commercial payers have expanded utilization management programs. Audit activity across molecular diagnostics remains elevated. Investors are focused on operational durability and reimbursement sustainability rather than scientific novelty alone.
As a result, technically strong assays can still struggle commercially if reimbursement, evidence generation, operational infrastructure, and go-to-market planning are not aligned early in development.
Some of the most valuable strategic discussions now occur before an assay is ever fully commercialized. Laboratories are engaging with reimbursement stakeholders, evaluating coding pathways, considering evidence requirements, and refining validation strategies upstream during assay development. In many respects, this is exactly how the system was intended to function—reimbursement and commercialization strategy informing development early enough to materially influence long-term adoption and sustainability.
The laboratories most likely to succeed during the next decade may not necessarily be those with the most technologically sophisticated platforms alone. Rather, they may be the organizations most capable of integrating scientific innovation, reimbursement strategy, evidence generation, operational scalability, and commercialization into a unified execution model from the outset.
Agendia CEO Straley summed up the challenge. “Innovation isn’t the roadblock anymore,” he said. “The real challenge is committing the time, resources, evidence generation, and organizational focus required to achieve adoption, reimbursement, and long-term commercial success.”
Jeffrey G. Jones is founder and managing partner of the Deerborne Group and has more than 30 years of executive and commercial experience in molecular diagnostics, genomics, and clinical laboratory services. Deerborne Group, founded in 2020, is a specialized strategy and management consulting firm focused on genomics and precision diagnostics. Its principals advise Fortune 500 companies, boards of directors, and leading venture capital and private equity firms on reimbursement, commercial, and corporate strategy.
The views expressed in commentaries published in CAP TODAY are not necessarily those of CAP TODAY or of the College of American Pathologists.
The growing disconnect between innovation and execution in molecular diagnostics
2026 Issues, ARTICLES, Molecular Pathology, October 2026, Subspecialties
Commentary
Jeffrey G. Jones
October 2026—Innovation in molecular diagnostics remains essential, yet the competitive advantage appears to be shifting from invention alone to execution.
The organizations most likely to shape the next generation of laboratory medicine may not be those that simply develop the most innovative technologies. Instead, it is likely to be those that can generate the evidence, secure the reimbursement, achieve the adoption, and scale the commercialization that are required to translate innovation into routine clinical practice.
This view was reinforced in discussions during and after the ASCO meeting this year with laboratory executives, reimbursement leaders, investors, oncologists, and pathology stakeholders, some of whose comments are shared here, and it is spoken of throughout the diagnostics industry.
scalability, and commercialization execution over extended time horizons.
Molecular diagnostics in the past decade has undergone one of the most remarkable periods of scientific innovation in modern health care. Next-generation sequencing, liquid biopsy, AI-driven pathology, multi-omics, and precision oncology have transformed what is technically possible inside the clinical laboratory.
At the same time, the industry itself appears to be entering a new phase of maturation. Historically, the most durable diagnostics markets ultimately developed commercially sustainable delivery models capable of supporting broad clinical adoption. In traditional in vitro diagnostics markets, this often involved standardized testing performed across hospital and regional laboratory networks. In molecular diagnostics, however, the emergence of high-complexity laboratory-developed tests enabled highly centralized reference laboratory models that have remained dominant across many segments of the market. Whether portions of liquid biopsy and other measurable residual disease testing and multicancer early detection remain centralized, become more broadly distributed, or evolve into hybrid delivery models remains uncertain.
Despite this extraordinary scientific progress, many laboratories continue to struggle to achieve durable commercial adoption of their technologies.
The challenge facing CLIA laboratories is no longer innovation alone. The greater challenge is operational execution: reimbursement, evidence development, commercialization strategy, regulatory alignment, and long-term financial sustainability. And the disconnect between innovation and execution appears to be widening across the diagnostics industry.
Abbott’s recent acquisition of Exact Sciences for approximately $21 billion may further reflect how the diagnostics industry itself is evolving. Increasingly, the strategic value may lie not only in the underlying assays or technologies but also in the evidence infrastructure, reimbursement positioning, operational scale, physician access, and commercialization capabilities required to support durable clinical adoption over extended time horizons.
Many founder-led laboratories and early-stage diagnostic companies still follow a familiar sequence: develop the assay, validate the technology, launch the laboratory-developed test, and then begin thinking about reimbursement strategy. Historically, that model may have been sufficient in portions of the molecular diagnostics market. Today, it is not.
In the current reimbursement environment, particularly within advanced molecular diagnostics, reimbursement strategies often influence assay architecture itself. Validation design, intended use, coding strategy, clinical utility endpoints, operational scalability, and commercialization planning need to be considered in parallel with assay development rather than after the fact.
This shift has become particularly visible within liquid biopsy and other oncology testing. Scientifically, the innovation has been extraordinary. Commercially, however, even some of the industry’s most heavily funded and technically advanced companies continue to face lengthy evidence-generation cycles, evolving payer expectations, and extended reimbursement timelines before broad clinical adoption can occur.
David Harding, SVP of pipeline product management at Exact Sciences, now Abbott, described the challenge succinctly: “Ultimately, it’s about the math.” As diagnostics move toward large population screening applications, particularly within multicancer early detection (MCED), demonstrating clinical utility often requires extraordinarily large and expensive clinical studies involving tens of thousands of patients. Generating the evidence required to support adoption, reimbursement, and guideline inclusion becomes the defining factor separating promising technologies from durable commercial successes.
MCED testing may now represent one of the clearest examples of the growing disconnect between scientific innovation and commercial execution across molecular diagnostics. Companies such as Grail with Galleri, Abbott with Cancerguard, and others have helped accelerate investor enthusiasm and broader market awareness surrounding blood-based multicancer screening technologies.
Scientifically, the progress has been extraordinary. Yet despite substantial investment, extensive clinical studies, and rapid technological advancement, broad reimbursement and clinical adoption remain largely unresolved. Grail, for example, currently markets Galleri primarily as a cash-pay offering priced at about $949 out-of-pocket despite significant market visibility and years of evidence generation.
Grail’s January 2026 premarket approval application submission for Galleri to the Food and Drug Administration represents a major milestone for the broader MCED industry. Supported by extraordinarily large clinical studies, including PATHFINDER 2 and the NHS-Galleri trial, which involved more than 140,000 participants in the United Kingdom, the submission represents one of the FDA’s first attempts to evaluate population-scale multicancer blood screening. Importantly, the FDA’s review extends well beyond analytical performance alone. Clinical utility, false-positive rates, downstream diagnostic workups, health care economics, and overall population-level benefit become central determinants of regulatory approval and eventual clinical adoption.
The February 2026 enactment of the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, establishing a Medicare coverage pathway for FDA-approved MCED tests, is another important milestone for the industry. However, the legislation should not be interpreted as automatic reimbursement. The Centers for Medicare and Medicaid Services and commercial payers will still require substantial evidence demonstrating clinical utility, economic value, and appropriate integration into clinical workflows before broad coverage and adoption occur.
Beyond reimbursement, achieving inclusion in National Comprehensive Cancer Network and other clinical practice guidelines often represents another critical execution milestone. Richard Bender, MD, practicing oncologist and former medical director at Quest Diagnostics, said physician adoption ultimately depends on evidence generation and guideline inclusion. “The NCCN guidelines have become the go-to reference for practicing oncologists and often determine whether a new molecular diagnostic test becomes part of routine clinical practice,” he said.
In many respects, MCED highlights how the diagnostics industry itself has matured. The challenge is no longer simply developing the technology. It is sustaining the time, capital, evidence generation, reimbursement strategy, operational scale, and commercialization execution required to achieve durable clinical adoption.
These realities are not unique to MCED. Evidence generation, reimbursement, physician adoption, and guideline inclusion, across molecular diagnostics, are increasingly determining which technologies achieve durable commercial success. Mark Straley, CEO of Agendia, said, “You don’t really have a business until you’ve generated sufficient evidence to drive physician adoption and guideline inclusion. That process often takes seven to eight years or longer and far exceeds what many companies initially anticipate.”
Liquid biopsy and other measurable residual disease testing further illustrates how molecular diagnostics is evolving beyond scientific innovation alone. Advances in next-generation sequencing, ctDNA detection sensitivity, and tumor-informed assay design have transformed what is technically possible in oncology diagnostics.
Companies such as Natera with Signatera, Guardant Health with Guardant Reveal, Exact Sciences, Personalis, Tempus, and others have helped accelerate investment and clinical interest across the MRD landscape. Portions of the category have already begun achieving meaningful reimbursement traction. Natera’s Signatera, for example, has secured Medicare coverage across multiple oncology indications, with reimbursement rates approaching about $4,000 per test in certain covered settings. Other MRD assays have similarly secured MolDx coverage in select colorectal cancer surveillance applications.
Despite this progress, much of the expanding solid tumor measurable residual disease testing market continues to operate primarily through advanced LDT models. In part, this reflects the significantly greater biological and operational complexity associated with solid tumor MRD testing itself. Many current approaches remain tumor-informed, requiring an initial tissue biopsy and individualized assay development based on the patient’s unique tumor signature. While these approaches may offer important analytical advantages in certain settings, they also introduce additional challenges for workflow, scalability, turnaround time, tissue acquisition, and longitudinal monitoring.
Competition within MRD testing is no longer centered on analytical sensitivity or technical differentiation. Rather, reimbursement strategy, evidence generation, pharma partnerships, operational scalability, physician adoption, and payer access are becoming equally important competitive factors. The strategic importance of MRD testing is also reflected in broader industry consolidation activity, including Quest Diagnostics’ acquisition of Haystack Oncology, highlighting the growing value placed not only on assay performance but also commercialization infrastructure, payer access, and scalable distribution.
As Eric Vail, MD, director of molecular pathology at Cedars-Sinai Medical Center, said, “I’m willing to sacrifice cutting-edge capability for stability. In a clinical laboratory, consistency and reliability often matter more than being first.” His observation highlights another often-overlooked reality of adoption: Laboratories must balance innovation with workflow integration, operational performance, and the risks of implementing rapidly evolving technologies.
In many respects, MRD testing reflects how the diagnostics industry itself is maturing. Technically strong assays alone are no longer sufficient to guarantee durable commercial success. Increasingly, the organizations most likely to succeed may be those that can integrate scientific innovation, evidence development, reimbursement strategy, operational scalability, and commercialization execution over extended time horizons.
At the same time, the broader operating environment for laboratories has grown more complex. MolDx technical assessment expectations continue to evolve. Commercial payers have expanded utilization management programs. Audit activity across molecular diagnostics remains elevated. Investors are focused on operational durability and reimbursement sustainability rather than scientific novelty alone.
As a result, technically strong assays can still struggle commercially if reimbursement, evidence generation, operational infrastructure, and go-to-market planning are not aligned early in development.
Some of the most valuable strategic discussions now occur before an assay is ever fully commercialized. Laboratories are engaging with reimbursement stakeholders, evaluating coding pathways, considering evidence requirements, and refining validation strategies upstream during assay development. In many respects, this is exactly how the system was intended to function—reimbursement and commercialization strategy informing development early enough to materially influence long-term adoption and sustainability.
The laboratories most likely to succeed during the next decade may not necessarily be those with the most technologically sophisticated platforms alone. Rather, they may be the organizations most capable of integrating scientific innovation, reimbursement strategy, evidence generation, operational scalability, and commercialization into a unified execution model from the outset.
Agendia CEO Straley summed up the challenge. “Innovation isn’t the roadblock anymore,” he said. “The real challenge is committing the time, resources, evidence generation, and organizational focus required to achieve adoption, reimbursement, and long-term commercial success.”
Jeffrey G. Jones is founder and managing partner of the Deerborne Group and has more than 30 years of executive and commercial experience in molecular diagnostics, genomics, and clinical laboratory services. Deerborne Group, founded in 2020, is a specialized strategy and management consulting firm focused on genomics and precision diagnostics. Its principals advise Fortune 500 companies, boards of directors, and leading venture capital and private equity firms on reimbursement, commercial, and corporate strategy.
The views expressed in commentaries published in CAP TODAY are not necessarily those of CAP TODAY or of the College of American Pathologists.
INDUSTRY NEWS