Out-of-Body Experience: Examining In-Vitro Diagnostic Tech

Next-generation sequencing (NGS) is a high-throughput, parallel DNA sequencing technology that lets scientists analyze entire genomes or specific DNA/RNA regions in a single day. It breaks DNA into fragments and sequences millions of them simultaneously. This provides rapid, cost-effective, and accurate genetic data that has the potential to revolutionize diagnostics, oncology, and research.

NGS for minimal residual disease (MRD) detects trace amounts of cancer cells remaining after treatment. It offers higher sensitivity than flow cytometry, particularly for blood cancers like acute lymphoblastic leukemia (ALL) and multiple myeloma. It identifies specific clonal mutations or gene rearrangements to help guide therapy decisions.

Oxford Gene Technology (OGT) is a developer of NGS-based tests for MRD. The company’s SureSeq Myeloid MRD Plus NGS Panel leverages hybrid capture to offer a user-friendly NGS workflow for detection of ultra-low frequency measurable residual disease (MRD)-associated biomarkers in acute myeloid leukemia (AML). Users of the panel can gather detailed genomic information to provide an earlier, more complete picture of their sample’s MRD status.

Accurately detecting MRD is a necessary part of advancing clinical research and improving understanding of therapeutic strategies for AML. Evidence has shown that MRD-negative status is related to improved long-term outcomes and the ability to sensitively identify a small number of residual leukemic cells earlier, giving clinicians and researchers a more detailed picture of disease status.

AML is a very heterogeneous disease and a challenge is understanding how different genetic variants contribute to disease dynamics, including those present at very low frequencies. Key biomarkers FLT3-ITDs and NPM1 commonly found in cases of AML relapse have traditionally been analyzed using single-analyte technologies and those markers are included in the panel.

However, they alone aren’t sufficient to characterize all AML presentations.

“Drawing from the ELN guidelines for AML MRD, the panel incorporates targets that support a more comprehensive understanding of MRD dynamics, covering multiple major AML-related biological pathways, including: hematopoiesis (FLT3, KIT, CSF3R); RAS–MAPK signaling associated with cell growth, differentiation, and survival (KRAS, NRAS); JAK–STAT signaling (JAK2, CSF3R); Epigenetic regulation and cellular differentiation (IDH1, IDH2, WT1); Transcription factor and differentiation pathways (RUNX1, CEBPA, NPM1); Spliceosome machinery (SF3B1); and Tumor suppressor and DNA damage response pathways (TP53),” said Dr. Graham Speight, executive VP of R&D at OGT. “Some genes contribute to more than one pathway, reflecting the biological complexity of AML. With these targets, the panel supports a more complete understanding of MRD status, capturing diverse genetic markers that vary both across and within individuals.”

In the near future, the opportunity for NGS-based MRD diagnostics in AML will involve translating recent technical advances into clinically usable tools, Dr. Speight explained. International guidance updates have clarified expectations around analytical sensitivity that is needed to track specific AML biomarkers.

These developments are helping establish a more clarified performance benchmark for next-generation assays and shaping how labs and clinicians think about MRD assessment at the molecular level.

“As the field matures, efforts are expected to converge on standardizing ultra-high sensitivity (UHS) detection within multigene NGS workflows rather than single-marker approaches,” said Dr. Speight. “This shift reflects the biological complexity of AML and the need to capture multiple coexisting and evolving variants within a single assay. An example for this would be for FLT3-ITDs, a well described AML-associated variant that is often an unstable genomic marker across the disease and treatment journey. The latest ELN guidelines recommend that for follow-up monitoring this should not be used as a sole MRD marker by UHS NGS when other MRD markers are available.”

The question that must be addressed in parallel, Dr. Speight urged, is how detecting ultra-low-frequency variants relates to outcomes. More understanding of when molecular relapse translates into clinical relapse will be essential to define how the assays can guide patient management in routine practice.

Once the links are more aptly understood, NGS-based MRD diagnostics could offer faster, more comprehensive insight into a patient’s genomic landscape. Shorter turnaround times merged with broader genomic coverage could fuel the shift to a more proactive, precision-led strategy.

Dr. Speight believes in the longer term that NGS-based MRD testing will become an embedded component of AML care. Molecular monitoring will be increasingly integrated into standard practice, and as evidence accumulates and assay performance becomes more consistent, routine MRD screening could support decision-making from post-treatment assessment through longer-term surveillance.

He also said the approaches will play more of a role in clinical research to evaluate therapeutic response. More integration of NGS-based MRD testing into clinical trial programs can help build an evidence base for precision medicine to support better stratification of risk.

Further, the method can help better identify patients more likely to benefit from certain therapies and allow more tailored treatment strategies earlier in the disease journey—more effectively managing patients across the course of their disease.

“Realizing this vision will depend on overcoming several practical challenges,” said Dr. Speight. “Continued progress in assay standardization will be essential, alongside the development of cost-effective solutions that support repeat testing over time. Equally important will be a greater focus on patient-centered sampling strategies, including the use of less invasive samples such as peripheral blood. Together, these advances will help ensure that genomic MRD testing is not only scientifically robust, but also scalable, accessible, and meaningful in real world clinical care.”

Dissecting Diagnostics

Behind every successful in-vitro diagnostic product is a network of specialized partners that bring ideas to life at scale. As demand for in-vitro diagnostic technologies grows, these providers are crucial to ensure quality, compliance, and speed to market.

To keep pace with the IVD technology manufacturers they support, these specialized partners support everything from diagnostic instrument manufacturing to assay development to full-scale production. Given their unique perspective on the industry, Medical Product Outsourcing spoke to the following experts:

• Robert Morin, vice president of sales & marketing, PDC
• Rich Jones, vice president, Global In Vitro Diagnostics and Life Sciences, Phillips Medisize
• Katie Schindler, R&D scientist, Mitsubishi Chemical Group
• A team of experts from TekniPlex

Sam Brusco: What are the main market forces at play in your sector of in-vitro diagnostic (IVD) technology?

Robert Morin: The IVD sector is defined by a significant post-COVID market reset. Federal funding and emergency demand during the pandemic drove rapid investment across OEMs, diagnostics developers, and consumables suppliers. This spurred innovation and capacity growth, but also overcapacity and new entrants.

With normalized testing volumes, the market corrected. OEMs now operate with more discipline; many suppliers face unused capacity and pricing pressure. Capital is tighter, and program selection is stricter. For consumables molders, the shift is clear: the market now prioritizes scalable manufacturability, cost control, and reliable suppliers over speed and capacity expansion.

OEMs are consolidating suppliers, seeking partners who can do more than mold parts. They prefer partners who support integrated systems like fluid handling, multi-materials, and assembly.

Rich Jones: The diagnostics landscape is at an inflection point where scientific capability and commercial reality must converge. On the technology side, we’re seeing precision medicine and companion diagnostics driven by richer biomarker sets, expanded sequencing and digital PCR, and the emergence of multiomics ecosystems—all increasingly paired with AI-enabled interpretation. Tissue biopsy remains foundational but liquid biopsy platforms are rapidly maturing toward clinical use. At the same time, point-of-care and over-the-counter testing are expanding patient accessibility, and labor pressures in clinical labs are accelerating the shift to CLIA-waived devices and instrument automation.

These technical advances are unfolding against clear market forces. Capital cycles have reset since the COVID investment surge—access to growth funding now determines which innovations can scale. Consumer-driven decentralization is real: sample to answer simplicity, privacy, and user experience increasingly dictate uptake. Meanwhile, regulatory and reimbursement friction remain the decisive commercial hurdles—tests that can demonstrate clinical utility and economic value win market access. Technology convergence and AI broaden what’s possible, but adoption depends on explainability, rigorous validation, and workflow integration. Practical commercialization ultimately comes down to manufacturing scale, quality systems, and resilient supply chains, while incumbent dynamics and global regulatory divergence shape regional strategies and timelines.

My view is pragmatic: the next wave of impactful IVDs will be those that pair scientific novelty with commercialization readiness inclusive of platform scalability, robust real-world evidence, payer engagement, user-centric design, and manufacturability. Companies that align technical innovation with clear clinical value, streamlined user experiences, and reproducible supply will be the ones that convert promise into sustained clinical and commercial impact.

Katie Schindler: Advances in digital health infrastructure—particularly the integration of data connectivity, cloud-based platforms, and AI enabled analytics—are reshaping the industry toward more decentralized, rapid, and patient-centric testing models. As this momentum continues, IVD manufacturers increasingly prioritize partners who can deliver quick turnaround, cost-effective solutions, and dependable customer support to keep pace with fast-moving product development cycles and rising market expectations.

TekniPlex: One of the most significant forces shaping the IVD market is increasing regulatory complexity—particularly in Europe with the implementation of IVDR, which is raising expectations around traceability, robustness, and overall product performance. This is driving the need for higher-quality materials and more controlled manufacturing environments.

At the same time, diagnostics are becoming more advanced and more widely used at or near the point of care. Technologies such as PCR (polymerase chain reaction) continue to serve as the backbone of molecular diagnostics, enabling personalized, highly precise detection of pathogens and biomarkers. These systems are increasingly being miniaturized into “lab-on-a-chip” formats, which combine complex laboratory functions into a single cartridge.

Another important trend is automation and digitalization. Laboratories are moving toward more automated workflows, integrating robotics and data-driven analysis (including AI) to increase speed, accuracy, and throughput.

Finally, there is a growing challenge around scalability. While many diagnostic innovations originate in research environments, successfully scaling these complex assays into high-volume, cost-effective production remains a key hurdle for the industry.

Brusco: What’s in the near future/what are you most excited about to come in the IVD market?

Morin: The market is entering a more disciplined, more meaningful phase. COVID sped up investment, but the correction shifted focus to clinical value, manufacturable designs, and cost-effective testing.

We see continued momentum in microfluidic and sample-to-answer consumables, with increasing functionality being integrated into smaller, more complex disposable systems. This is driving demand for tighter tolerances, multi-material integration, and more advanced fluid control. Platform-based devices are also rising as OEMs standardize consumables and build modular, adaptable systems. 

Supply chain strategies are evolving. OEMs now favor fewer, more capable partners supporting development, tooling, and production close to home.

More broadly, as diagnostics continue to decentralize, there is an opportunity to improve access to care by enabling reliable testing closer to the patient. The next market leaders will be those able to integrate materials, molding, fluid management, and assembly into a cohesive manufacturing process.

Jones: What I find most exciting in the near-term IVD landscape is not a single breakthrough but the convergence of capital, evidence, patient-centric sampling, and computational intelligence that together make clinically meaningful diagnostics practicable at scale.

We’re already seeing a return of capital and strategic M&A into diagnostics—and that matters. Renewed investor and strategic buyer interest accelerates scale up, funds rigorous prospective evidence generation, and shortens the path from promising technology to commercial rollout. That flow of capital will separate technologies that can demonstrate durable clinical and economic value from those that cannot.

Blood-based early detection and MRD monitoring are moving toward real-world utility. Advances in circulating tumor DNA and other liquid biomarkers are improving sensitivity and specificity for both screening and post therapy surveillance. Paired with prospective clinical validation and payer engagement, these assays have the potential to shift oncology toward earlier intervention and more individualized treatment strategies.

Practical at home blood collection is becoming a reality. Improvements in low-pain collection methods, volumetric microsampling and user centric devices will make high quality capillary sampling feasible outside traditional labs. That expands access, enables more frequent longitudinal monitoring, and generates richer datasets to inform care without adding clinic burden.

AI and computational diagnostics are true force multipliers. Machine learning and cloud analytics can enhance signal extraction, standardize interpretation, and prioritize actionable results for clinicians. To realize those gains at scale we’ll need transparent model explainability, rigorous validation, and seamless clinical integration, not black box scoring alone.

The winners will be platforms that marry scalable manufacturing and logistics with robust clinical evidence and clear reimbursement pathways. The most successful solutions will balance technical novelty with an excellent user experience and demonstrable value for payers and providers.

Together—fresh capital, validated blood assays, practical decentralized sampling, and AI-enabled interpretation—these trends point toward diagnostics that follow patients wherever they are, enable earlier detection and smarter monitoring, lower friction in care pathways, and ultimately improve outcomes and system efficiency.

Schindler: The near future of the IVD market is defined by rapid global expansion and the continued rise of point-of-care and at-home diagnostic modalities. The convergence of connected devices with highly accurate, consumer-friendly testing platforms is transforming access to healthcare—particularly for underserved and geographically remote populations. This shift is enabling more equitable, real-time clinical insights regardless of location.

Equally exciting is the accelerating integration of artificial intelligence across the diagnostic ecosystem. AI-driven analytics are unlocking the ability to translate complex biological signals into actionable, data informed recommendations, supporting earlier detection, and personalized care pathways. Together, these advancements signal a transition toward a more distributed, intelligent, and patient-centric diagnostic model—one that has the potential to redefine how and where care is delivered.

TekniPlex: One of the most exciting areas in the IVD market is the continued advancement of molecular diagnostics and their impact on clinical decision-making. These technologies are enabling faster, more precise diagnoses, which can significantly improve patient outcomes and streamline treatment pathways.

From a materials and manufacturing perspective, scalability remains a central challenge and an opportunity. The ability to industrialize highly complex diagnostic assays will be a key enabler for broader adoption. Technologies such as high-pressure thermoforming and advanced polymer processing are opening new pathways to produce intricate microfluidic systems at scale while maintaining precision and consistency.

There is also growing momentum around innovation in materials, particularly in response to evolving regulatory landscapes and sustainability considerations, such as potential restrictions on certain chemistries (e.g., PFAS). This is creating opportunities for alternative materials and surface technologies that can meet both performance and compliance requirements.

Finally, we are encouraged by the innovation pipelines within smaller diagnostic companies as well as well-known industry players. As a materials and film solutions partner, we are proud to participate in and enable these developments, providing the critical components that make new diagnostic technologies possible.