So far in this Biomarker Edge series, we’ve learned exclusively from academic researchers. How are partners in the pharmaceutical industry leveraging the ultra-high sensitivity, multiplexed targets, and fully automated capabilities of NULISA? 

Workhorse instrument for drug development 

Dr. Bailin Zhang oversees Sanofi’s Disease Profiling and Functional Genomics team in Cambridge, MA. Impressed by early participation in the technology access program, Sanofi employs four ARGO HT instruments in the US and Germany to identify translatable biomarkers for clinical use. Dr. Zhang emphasized the deployment of the NULISAseq Inflammation Panel AQ and CNS Disease Panel 120 across various sample matrices, including biofluids, tissue lysates, and cell culture extracts (see our tech note for more on alternative sample types and NULISA). These initiatives support biomarker discovery across several stages of drug development, including understanding drug mechanisms, evaluating efficacy and toxicity, and selecting lead candidates. 

Using clinical plasma samples from patients with inflammatory bowel disease (IBD) and healthy controls, NULISA captured key circulating biomarkers that were previously elevated in IBD biopsy samples. These biomarkers can be routinely measured less invasively, simplifying clinical research. 

Characterizing bispecific antibodies comprised of two nanobodies targeting different receptors raises the question: is 1+1>2? In a T-cell/B-cell co-culture assay using donor peripheral blood mononuclear cells (PBMCs), the team used NULISA to develop synergistic scores in identifying the optimal nanobody combination to advance through the pipeline. 

The NULISAseq Mouse Panel 120 offers the group opportunities to assess preclinical drug efficacy and toxicity. Examples include brain tissue lysates from a mouse model of Alzheimer’s disease (AD) and a rat model of immune toxicity. 

Finally, NULISA proteomics offers a platform for linking genotype with disease phenotype. Protein-protein interaction analysis of a Gaucher disease (GD) cohort, comprising over 1600 biofluid samples from more than 300 patients, identified a robust longitudinal biomarker of GD severity and treatment response. In addition to providing a critical measurement in GD, this signal may also be relevant to other lysosomal storage diseases.  

NULISA for CROs: designed to be a clinical tool 

Dr. Jingwen Tan is the Director of Biomarker Services at Frontage Laboratories, a science-driven global contract research organization (CRO) that leverages best-in-class bioanalytical technologies for clinical biomarker research. It’s no surprise that her team employs an ARGO HT to identify the “ideal biomarker” for patient diagnosis. 

In describing the regulatory compliance requirements for clinical endpoint analysis, Dr. Tan called NULISA a “good tool to support clinical trial analysis.” Her team has extensive experience in managing the utility of clinical biomarkers in pharma, including validating over 70 methods to support AD drug development. So, getting her perspective on how NULISA can bridge biomarker discovery to bioanalysis was reassuring.  

The key features of NULISA and the ARGO HT that Dr. Tan highlighted as aiding in eventual regulatory compliance for clinical biomarker use include: 

• Time and cost-effectiveness: two days of hands-free workflow with small sample volumes 

• Excellent detectability, library reads, and precision (CVs) in close alignment with what is reported in Alamar’s product sheets 

• High-throughput panels enable comprehensive analysis of each sample 

• Straightforward validation of the bioinformatics software at Frontage to meet 21CFR Part 11 compliance and ensure data security

   

Using NULISA and ARGO HT to explore highly sensitive bioanalytical assays early on in drug development can support the discovery of surrogate biomarkers and companion diagnostics, which are essential for identifying likely responders and achieving clinical endpoints. 

Solving clinical shortcomings with sensitivity and multiplexing 

Recent research from nephrologist Dr. Jamie Lin of MD Anderson Cancer Center tells an intriguing tale of addressing unmet needs in clinical practice. Dr. Lin specializes in immune-related adverse events (irAEs) linked to immune checkpoint inhibitor (ICI) therapy, particularly kidney injuries. While ICIs have revolutionized cancer treatment, they are also associated with severe irAEs, including acute interstitial nephritis (AIN).  

ICI therapy works by activating T cells that otherwise were not engaged in fighting tumors, but this can also lead to attacking healthy tissue. Compared to other tissues, ICI-associated nephritis is less common but difficult to diagnose. ICI-AIN is confirmed by ruling out other causes of acute kidney injury, which requires an invasive biopsy performed by a skilled specialist. This process can take weeks to schedule and carries a high risk of bleeding. Additionally, diagnosing AIN necessitates pausing ICI therapy until a diagnosis is confirmed, which can be life-threatening for late-stage patients. Moreover, delayed diagnosis leads to permanent kidney damage in 60% of cases. 

Having clearly advocated for a faster, safer, and more accurate diagnostic method for ICI-AIN, Dr. Lin laments that most assay technologies lack the sensitivity, multiplexing, and quick turnaround time needed for urine-based diagnosis. The solution? The NULISAseq Inflammation Panel 250, which identified 59 biomarkers uniquely in urine (compared to 22 in plasma) that were significantly linked to ICI-AIN. Using machine learning techniques, her team narrowed the list to two biomarkers, the cytokine IL-5 and the apoptosis-triggering receptor Fas, which could predict ICI-AIN with 94% accuracy (Long et al., 2025). 

Read our blog to learn more about Dr. Lin’s work and other examples of irAE biomarkers in cancer immunotherapy. 

What’s next? 

NULISA technology is currently for research use only, but, as Dr. Tan reveals, the platform and ARGO HT instrument were designed for clinical utility. Researchers in biopharma and academic institutions already use NULISA for exploratory clinical biomarker research, and efforts are underway to ensure regulatory compliance for its use in clinical endpoints.  

Dhivya Venkat, CEO and Founder of Esya Labs, emphasizes the value of multiplexing in point-of-care diagnostics at emergency centers to support diagnosis and determine the appropriate treatment. Could NULISA-discovered urine biomarkers help identify patients at risk of acute kidney injury? Dr. Lin is working on this. Mrs. Venkat also highlights the importance of developing lab-directed test (LDT) assays as a “sanity check for gauging market interest in new products, building a network of key opinion leaders, and serving as a springboard for regulatory approval.” NULISA’s sensitivity, multiplexing, and automation tools satisfy the insatiable curiosity of researchers worldwide.