Abstract
Amyotrophic Lateral Sclerosis (ALS) remains one of the greatest challenges in neurology, with no definitive cure and a diagnostic delay of over 12 months that critically limits therapeutic options. Our project, ALSense, seeks to transform this paradigm by developing a synthetic biology–based biosensor capable of detecting ALS-specific biomarkers in a small blood sample.
The system integrates the detection of neurofilaments, which reflect neuronal damage, and cryptic peptides derived from TDP-43 dysfunction, a molecular hallmark of ALS. This dual-marker approach aims to deliver a fast, minimally invasive and cost-effective diagnostic tool, enabling earlier detection than current clinical pathways, potentially even before symptom onset.
Beyond diagnosis, ALSense offers opportunities for monitoring disease progression, supporting clinical trials, and reducing healthcare costs associated with late-stage management. Our vision is to shift ALS diagnosis from a lengthy process of exclusion to a precise, accessible and scalable solution, with the potential to expand toward other neurodegenerative diseases.
Ultimately, ALSense aspires to provide patients and families with something medicine cannot yet guarantee: more time, more options and more hope.
Mission
To make ALS diagnosis faster, earlier, and fairer.
Detecting ALS at the molecular onset, not after neuronal damage is advanced.
Accelerating the diagnostic journey from over a year to just days or weeks.
Vision
A future where no ALS patient has to endure months of uncertainty before receiving a definitive diagnosis.
Patients could access treatments and clinical trials earlier, while care teams could design holistic support plans from the very beginning.
Values
Patients are at the heart of every decision we make.
We cultivate passion, resilience and a positive mindset.
We build bridges believing that the best outcomes emerge from working together.
Mission
Our mission is to make ALS diagnosis faster, earlier, and fairer. With ALSense, we aim to develop a molecular biosensor that can detect ALS at its "silent" stage: before the first motor symptoms appear. By bringing together synthetic biology, biomarker research, and clinical needs, we want to provide patients and clinicians with a reliable, accessible and cost-effective diagnostic tool.
We work towards:
- Detecting ALS at the molecular onset, not after neuronal damage is advanced.
- Accelerating the diagnostic journey from over a year to just days or weeks.
- Empowering earlier clinical interventions, offering patients better quality of life and more therapeutic options.
- Generating impact at three levels: clinical (improved outcomes), scientific (new data and biomarkers), and social (reducing uncertainty and giving families hope).
Vision
We envision a future where no ALS patient has to endure months of uncertainty before receiving a definitive diagnosis. Within the next decade, ALSense aims to be consolidated as a science-based startup, with a clinically validated biosensor routinely used in hospitals.
By diagnosing ALS at its invisible stages, patients could access treatments and clinical trials earlier, while care teams could design holistic support plans from the very beginning. Our long-term vision is to establish a new standard in ALS diagnosis, combining scientific innovation, clinical applicability, and human impact. Together with extending this approach to other neurodegenerative diseases in the future.
Values
At ALSense, four values guide our work:
Social Commitment
Patients are at the heart of every decision we make. We act with empathy and responsibility.
Innovation
We embrace creativity, scientific rigor, and disruptive thinking to challenge the status quo in neurodegenerative diagnostics.
Joy and Optimism
Even in the face of a devastating disease, we cultivate passion, resilience and a positive mindset. Every small scientific step forward is a reason to celebrate.
Collaboration
Facing ALS requires a united effort. We build bridges between scientists, clinicians, engineers, organizations and patient communities, believing that the best outcomes emerge from working together.
The Problem
ALS is a progressive neurodegenerative disease that attacks motor neurons, leading to loss of movement, speech, swallowing and eventually breathing. The average life expectancy is only 3 to 5 years after diagnosis. Yet, diagnosis itself is delayed, often more than 12 months, due to its reliance on ruling out other diseases through costly, specialized tests.
This delay robs patients of precious time. Although current therapies cannot cure ALS, they can slow progression and significantly improve quality of life if applied early. A tool for fast, specific and accessible diagnosis is urgently needed.
Scientific Relevance
Early diagnosis of ALS is still a critical and underexplored frontier. By developing a biosensor based on synthetic biology and specific biomarkers, ALSense aligns with international scientific efforts to create faster, more precise and more accessible diagnostic systems. This innovation not only enhances detection but also enables better monitoring of treatments and early inclusion in clinical trials.
Social Relevance
The impact of ALS extends beyond the patient to families and caregivers. In Spain alone, three new cases are diagnosed every day, and most of the care burden falls on relatives. Foundations such as Fundación Luzón and Fundación Miquel Valls highlight the urgent need for professional support, which currently demands thousands of hours of specialized care each year.
An accessible diagnostic tool could be a turning point: improving prognosis, allowing early planning of medical and psychological support and relieving the emotional and social weight carried by families.
Economic Relevance
ALS also carries a staggering economic burden. The annual cost of care for an advanced ALS patient can exceed €114,000, about four times the average salary in Spain. Ensuring round-the-clock professional care for severe cases would require hundreds of millions of euros annually at the national level.
By reducing diagnostic delays, ALSense has the potential to lower avoidable healthcare expenses, such as prolonged hospitalizations and late-stage intensive care, contributing to a more sustainable healthcare system.
Our Solution
ALSense is developing a next-generation molecular biosensor for the early detection of ALS. What makes it different is that it looks for the disease at its molecular starting point, not after visible symptoms appear.
The biosensor combines two complementary biomarkers:
- Neurofilaments: These proteins leak into blood when motor neurons are damaged. They are already recognized in clinical research as indicators of neurodegeneration. High levels are a red flag that something is going wrong in the nervous system.
- Cryptic peptides: These are abnormal protein fragments that appear only in TDP-43 diseases (such as ALS and frontotemporal dementia), caused by errors in RNA splicing due to malfunction of the TDP-43 protein. More than 97% of ALS cases show this defect, making cryptic peptides a highly specific "molecular fingerprint" of the disease.
By detecting both markers at once, our system improves diagnostic accuracy: neurofilaments provide sensitivity (detecting neuronal damage), while cryptic peptides provide specificity (linking that damage directly to ALS).
The biosensor is designed to be:
- Fast: Giving results in a fraction of the time compared to today's long diagnostic journey.
- Minimally invasive: Just a small blood sample is needed.
- Accessible and affordable: Adaptable to standard hospital labs, and potentially usable beyond large medical centers.
In short, ALSense aims to shift ALS diagnosis from a long process of exclusion to a direct, reliable, and scalable test.
Future Uses
Clinical Practice
ALS journey: shaping how patients are monitored & how treatments are developed.
Helping doctors see whether the disease is advancing more quickly or whether a therapy is slowing it down. In the future, we imagine this adapted into a portable device.
Clinical Trials & Research
To identify candidates sooner and build more homogeneous cohorts. This would accelerate the development of new drugs.
Future Expansion
Same design could be adapted to detect biomarkers from other neurodegenerative diseases such as Parkinson's, Alzheimer's or frontotemporal dementia.
Although ALSense is first and foremost a diagnostic tool, its potential goes far beyond simply giving patients an early answer. Once validated, our biosensor could become a companion throughout the ALS journey, shaping how patients are monitored, how treatments are developed and how medicine approaches other neurodegenerative diseases.
In clinical practice, the biosensor could evolve into a way of tracking disease progression over time. Today, ALS patients are usually evaluated every few months with clinical examinations that can be subjective and slow to capture change. With ALSense, each blood test could provide an objective measure of biomarker levels, helping doctors see whether the disease is advancing more quickly or whether a therapy is slowing it down. In the future, we imagine this becoming part of routine check-ups or even adapted into a portable device that allows more continuous follow-up.
For research, ALSense could act as a catalyst for clinical trials. One of the greatest challenges for new therapies is recruiting the right patients early enough. By offering a standardized, low-cost way to confirm ALS at its molecular onset, our biosensor could allow researchers to identify candidates sooner and build more homogeneous cohorts. This would accelerate the development of new drugs and, ultimately, give patients access to experimental treatments earlier in their disease.
Finally, the technology itself is inherently modular. While our initial focus is ALS, the same design could be adapted to detect biomarkers from other neurodegenerative diseases such as Parkinson's, Alzheimer's or frontotemporal dementia. In this sense, ALSense is not just a diagnostic tool: it is a platform with the potential to redefine how we approach neurological diseases as a whole.