A medical technologist loads a sample rack into an automated immunoassay analyzer, initiating the biomarker testing process for diagnostics in a certified laboratory.
Biomarkers have moved from “nice-to-have” to the backbone of drug development, says Quanterix’s Jorge Marques Signes, who argues they now shape feasibility, timelines and even payer expectations before sponsors commit thousands of patients or years of spend.
Jorge Marques Signes
“Biomarkers are not supplemental anymore,” said Marques Signes, VP of Accelerator & Clinical Services at Quanterix. “They are now part of the infrastructure of drug development and clinical trials.”
Marques Signes goes on to say that biomarkers are not only tools for understanding safety and efficacy, “which is incredibly important,” he added. “By integrating biomarkers, you are also determining feasibility: the cost, the timelines and the probability of success across all phases of development.”
The shift is visible in fields ranging from neuroscience to oncology. In oncology, circulating tumor DNA (ctDNA) guides patient selection and minimal residual disease (MRD) measurements are gaining regulatory traction: particularly in hematologic cancers like multiple myeloma, where an FDA advisory panel unanimously endorsed MRD as an endpoint to support accelerated approvals. In neurodegenerative disease, plasma-based p-tau217 is emerging as a frontline Alzheimer’s screen that can reduce reliance on cerebrospinal fluid (CSF) taps and amyloid PET scans. By integrating biomarkers early, Marques Signes contends, sponsors can pressure-test feasibility, ranging from cost to timelines and likely success. Ultimately, they can make earlier no-go decisions on weak arms while reallocating statistical power to the ones that matter.
What’s different now
Where biomarkers once supplemented efficacy and safety readouts, they now define trial entry criteria, establish regulatory evidence thresholds before enrollment begins, and shape commercial differentiation from the outset.
“Taking into account that oncology treatments could be very invasive, biomarker-guided trials tend to require fewer patients,” Marques Signes said. “Based on the surrogate biomarker you see, you can ask: Is this arm really making sense for me or not? You can shut down some arms, increase the statistical power on others.” The result is often faster regulatory decisions and market access.
In circulating tumor DNA (ctDNA)-guided oncology trials, for example, the biomarker serves dual purposes: patient stratification upfront and Minimal Residual Disease (MRD) monitoring as a potential early endpoint. In turn, that supports smaller trials with faster decision cycles. NCCN now recognizes ctDNA as a high-risk factor for recurrence in colon and rectal cancer. FDA guidance outlines how ctDNA can be used in early-stage solid tumor trials for patient selection and monitoring. It also provides a pathway for generating the validation data needed to establish ctDNA as a surrogate endpoint.
The growing use of biomarkers empowers sponsors. Instead of waiting for agency guidance, sponsors are increasingly bringing biomarker data to the FDA to shape qualification frameworks. “We see more and more examples where biopharma executives are no longer waiting for regulatory directions,” Marques Signes said. “They are engaging proactively with the agency to shape what is the biomarker qualification framework, how they can define the coverage model and what the industry standard is.”
The advantage, he added, is evidence-backed negotiation: “You have the biomarker that makes your opinion not an opinion anymore; you have backup. So you go there and say, ‘Look, I’m showing you this is happening, and this is happening this way.’ It really allows this productivity.”
Concrete data points from neurodegenerative disease
Marques Signes points to neurodegenerative disease as one area where this clinical utility shows up in specific metrics. Quanterix’s LucentAD Complete test, which measures p-tau217 alongside four other Alzheimer’s biomarkers (Aβ42/40 ratio, GFAP, and NfL) using its Simoa technology, reports a reduction in the “intermediate zone,” patients who fall between clear positive and negative results, from 31.2% to 10.5%. That triage efficiency matters for both clinical workflows and trial enrollment: fewer ambiguous calls mean faster decisions and less retesting.
The advance comes as FDA cleared the first blood-based in vitro diagnostic for assessing amyloid pathology in May 2025 (Fujirebio’s Lumipulse test).
“p-tau217 is a frontline screening tool right now,” Marques Signes said. The biomarker enables detection in plasma rather than CSF, eliminating the need for lumbar punctures. “You’re avoiding using CSF, but you’re also seeing how p-tau217 is being used alone without having to go to amyloid PET scans, which reduces not only the intervention on patients but also the cost.”
Sample requirements are modest, microliters in the lab, but the company is working on dried blood spot workflows for at-home collection. Quanterix has developed a Simoa Dry Blood Extraction Kit, with validation studies emerging. “Imagine in the future: similar to what we did with COVID. You’re at home, and it seems easy but it’s complicated because we need to normalize and reduce variability,” Marques Signes said. “But at the end, you have a simple system where your doctor tells you, ‘Let’s do this test,’ and you put a device on your arm, put it in a package, and send it out for disease progression or calculating the probability of disease.”
Market structure and funding realignment
These advances in biomarker technology are unfolding against a shifting federal funding landscape for scientific research. Since mid-2025, NIH award flow has come under pressure, with fewer R&D dollars awarded amid policy shifts. Neuroscience grants are down 37% compared to the previous nine-year average. With academic timelines mismatched to pipeline needs, patient advocacy groups and disease-focused nonprofits are increasingly brokering sample access and pushing biomarker development forward.
“What I’m seeing more and more are examples where specific non-governmental organizations built around patient advocacy groups are leading and pushing advances in therapies and supporting biopharma,” Marques Signes said. These organizations control physician networks, large cohort studies, and banked samples. Examples include the Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator, a $100 million initiative from partners including Bill Gates and Leonard Lauder, and the Parkinson’s Progression Markers Initiative (PPMI), a longitudinal study of over 1,500 participants sponsored by The Michael J. Fox Foundation.
Biopharma, in turn, is leading qualification efforts rather than waiting for academic consortia or government-funded initiatives to define standards. “I really believe biopharma will need to find critical partners,” Marques Signes said. “Due to these funding changes, I really believe that if we want to advance precision medicine and advance biopharma drug pipelines, it’s impossible for one company to have all the expertise inside.”
The service provider model, he argued, “pseudo-democratizes” expertise. When multiple sponsors need the same biomarker—such as interleukin-5 for inflammatory pathway studies—the lab accumulates experience across different matrices and contexts, accelerating subsequent projects without violating confidentiality. “The speed is something you accomplish by having this expertise,” Marques Signes said.
Data bridging and long-horizon strategies
One less visible but operationally important function is longitudinal data compatibility. By maintaining standardized controls and bridging protocols, Quanterix enables sponsors to make samples collected in 2026 directly comparable to those collected in 2028.
“The possibility of reusing studies will allow 2026 samples to be compatible with 2028,” Marques Signes said. “This kind of decentralizing strategy is almost a real situation where you have an expertise group for clinical trials that is there, but you just engage or not engage depending on the pipeline lifecycle point or your needs at that moment.”
That model turns a testing lab into something closer to a long-term data infrastructure partner. “I really believe that biomarker infrastructure, independently and more concentrated in biopharma, represents the foundation of the 21st century,” Marques Signes said.
Quanterix’s CLIA-certified Accelerator Laboratory received its New York State clinical laboratory permit in August 2025, becoming fully certified in all 50 states. In July 2025, Quanterix completed its acquisition of Akoya Biosciences, a move that integrates ultra-sensitive blood biomarkers with spatial tissue biology capabilities.
Filed Under: Neurological Disease
