Design

Objectives

The main objective is to develop a synthetic biology-based biosensor capable of detecting ALS-specific biomarkers in a blood test, making diagnosis faster, earlier and more accessible than current clinical pathways allow.

Our work focuses on several complementary goals. We aim to integrate three complementary biomarkers: neurofilaments (reflect neuronal damage) and two cryptic peptides (derived from TDP-43 dysfunction, a highly specific molecular hallmark of ALS) into a single diagnostic system. This dual approach seeks to combine sensitivity and specificity, reducing false positives and false negatives.

We are committed to the design and validation of a prototype that uses aptamers as molecular detection tools. Offering robustness, reproducibility and scalability, positioning the biosensor as a reliable and adaptable platform. Together with future preclinical validation, adaptability and accessibility, our vision is to ensure an implementable diagnosis tool.

Another key goal is to generate clinical and scientific impact. By enabling earlier diagnosis, ALSense would accelerate patient enrollment in clinical trials, improve disease monitoring, providing researchers with valuable data on biomarker dynamics during disease progression.

ALSense aspires to bridge the gap between cutting-edge biomarker research and real-world clinical practice, offering patients and families earlier answers and new possibilities.

Why now

ALS time

ALS remains one of the most urgent unmet needs in neurology. In Spain alone, between 4,000 to 4,500 people live with ALS, with nearly 900 new cases diagnosed each year. Diagnosis still takes an average of 12 to 18 months, a delay that robs patients of valuable time to access treatments, multidisciplinary care and clinical trials.

Recent reports from Fundación Luzón and Fundació Miquel Valls highlight three converging pressures that make early-diagnostic solutions more urgent than ever:

• Momentum: In October 2024 Spain approved the first national "Ley ELA," granting ALS patients the right to comprehensive care. Its success depends on earlier and more accurate diagnosis to connect patients with the new resources now guaranteed by law.
• Scientific opportunity: Biomarker research has advanced rapidly. Neurofilaments are now recognized as robust indicators of neuronal damage, and cryptic peptides linked to TDP-43 dysfunction are emerging as highly specific molecular signals of ALS onset. Yet no accessible diagnostic tools have translated this knowledge into routine practice.
• Economic and social cost: The ALS Observatory estimates that advanced care can exceed €114,000 per patient annually, with families shouldering much of the burden. Earlier diagnosis would allow more efficient planning of medical and social resources, while reducing unnecessary hospitalizations.
• Equity gap: Associations underline the fragmentation of ALS care across Spain: access to specialized units, caregivers, and equipment varies widely by region. A low-cost blood-based diagnostic tool could be deployed in hospitals nationwide, reducing inequalities.
• Rising investment in neurodegeneration research: Over the past decade, Spain has seen a steady growth in funding programs dedicated to ALS and other neurodegenerative diseases. Fundación Luzón, together with Fundación "La Caixa," launched the ALS Talent Fellowships (2017–2027), committing over €5 million to support young researchers, alongside the Unzué-Luzón Grants (€2.3 million for 2023–2026). At the public level, the Spanish Institute of Health (ISCIII) has invested more than €4 million to strengthen national ALS research networks. Clinical trials in Spain have increased by 75% since 2017, supported by international consortia such as TRICALS. This expanding ecosystem of grants, fellowships, and collaborations creates the perfect environment for projects like ALSense to thrive and accelerate translation of early diagnostic tools.

Taken together, these factors create a unique window of opportunity. The scientific community is calling for precise biomarkers, policymakers have recognized ALS at the national level and families demand earlier answers. ALSense responds directly to this moment: by transforming cutting-edge biomarker science into a simple, scalable biosensor, it provides the missing link between policy, research, and patient care.

Aptamers time

Although there has been a recent rise in aptamer-based technologies, aptamers remain one of the most unexplored promising tools in the synBio field. Potter Clarkson in collaboration with Inevus Advanced Analytics have conducted an in-depth analysis of European patent filings in synthetic biology, published between 2004 – 2023. One of the conclusions of the report is that the main topic of the patents published by EPO is by far antibody-related, with a 2018-2023 mean publication number of 2456 patents per year. In contrast, the 2018-2023 mean number of aptamer-related patents published is 114, which represents a 4,6% of the antibody-related ones. This means that while the field of antibodies is intensely exploited and with high competitiveness, the aptamer one is mainly unexplored.

Related to these numbers, we can observe the tendency in patent publications by field, and comparing the three fields of interest for ALSense with the most common one (Recombinant proteins and nucleic acids in this case), we can see that the interest in our fields has been rising for the last ten years but is not as exploited as others are. Among the topics concerning our project, aptamers remain the most infrequent one while the one with the highest percentual increase, which remarks the high potential this technology has.

Another interesting aspect of the mentioned report is the analysis of the patent grant rates by EPO. In all the cases with no exception there is a fall in the rate, and when taking the overall analysis, one can conclude that a grant rate above 30% is fairly good, and a one around 40% is among the best. In our cases, the three topics of our interest rise above the antibody-related grant rate, as well as many others. This is specially the case for biomarkers and diagnostics, which can make us think that the patent application process is not as complex as in other fields.

References