nQ Rx

nQ’s digital biomarkers can be deployed in a specialized role: Software as a Medical Device (SaMD) analyzes smartphone and keyboard typing patterns using compressed temporal typing data assisted by machine learning to identify abnormalities in cognition and fine motor function in adults with neurodegenerative diseases.  

nQ Rx can characterize these subsets of psychomotor function into a more objective and granular manner than current gold standard assessment tools. Physicians and patients can now have access to continuous real world evidence generated from functional, real-world data. 

nQ is working to deliver prescription digital biomarkers across a broad range of neurodegenerative diseases in support of early detection, remote patient monitoring, and improved treatment pathways. We aim to bring accurate, affordable accessible digital tools to patients everywhere. Here are some examples:

The effective treatment of PD is based on lifestyle and pharmacologic interventions that improve quality of life. Today, adjustments to medication regimens for Parkinson’s Disease (PD) patients are limited to information gathered by movement disorder specialists during on-site clinical examinations approximately every 6 months.

Current clinician assessment tools help provide objectivity and standardization to the clinical exam, however, due to the inherently subjective nature of physician-patient interview and the large degree of fluctuation in PD symptoms high degrees of inter-rater and intra-rater variability are still observed even when administered by highly trained professionals.

Additionally, these scales are not optimized to detect subtle motor fluctuations that can be present in early disease.

There is an urgent need to identify individuals manifesting initial symptoms of AD for the purpose of testing of new agents in clinical trials, to facilitate lifestyle modifications that impact disease course.

In the event that disease modifying therapies become mainstream, early identification of cognitive impairments combined with treatment will become crucial to maintain quality of life and improve outcomes.

Although several diagnostic tests are available that can identify patients in the earliest stages of the disease, these tests are prohibitively expensive (amyloid PET) or invasive (spinal tap) and are not feasible for screening millions of at-risk individuals.

New screening tools that are inexpensive, scalable, and minimally invasive are urgently needed to combat the looming Alzheimer’s disease epidemic.

Current methods to evaluate and monitor symptom severity in people with ALS rely on questionnaires, which are subjective and are designed to be done with the patient in clinic.

Perhaps the most commonly used outcome measure is the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), a 12-item questionnaire aimed at monitoring the progression of disability across four domains: gross motor tasks, fine motor tasks, bulbar function and breathing function.

By its nature, ALS is a heterogeneous disorder that can primarily affect any of these domains. Yet by using a scale that covers such a broad array of symptoms, we lose the ability to perform detailed tracking of disease progression in any one of these domains.

Gold standard outcome measures for clinical trials in MS have historically included annualized relapse rate and the Expanded Disability Status Scale (EDSS), a relatively insensitive measure of disease progression.

While these and other clinical outcome measures such as those included in the MS Functional Composite are familiar to and interpretable by clinicians and clinical researchers, they fail to assess many domains that are significant to PwMS.

Patient reported outcome (PRO) data that capture additional important dimensions of the MS experience are therefore increasingly being recognized as valuable tools for evaluating disease symptoms, quality of life, the effectiveness of therapies, and the status of disease progression in PwMS, both in clinical trials and in routine clinical evaluations.

nQ Medical (nQ) proposes that passive tools that collect data continuously in the remote environment have the potential to provide digital biomarkers as SAMD that track closely with PRO data across a number of functional domains to provide a solution that addresses unmet medical needs while advancing modern care and drug development.