Algorithm

MNd-5 generates probabilistic estimates of amyotrophic lateral sclerosis ("ALS") for individual patients based on data extracted from their electronic health records. The constellations of clinical and electromyogram (“EMG”) findings are categorized as “Unlikely,” “Equivocal” or “Probable” ALS when compared with a reference population in which ALS has been diagnosed or ruled out by clinical experts.

Clinical characteristics are extracted by trained members of the Ensho Clinical Operations Team using the Apollo aEDC system. Patients diagnosed with ALS or in which ALS has previously been ruled out are excluded from analyses as are individuals with prior traumatic brain injury, multiple sclerosis, Huntington's disease, chorea, essential tremors, and known genetic forms Parkinson's disease.

Performance Characteristics

MNd-5 was trained on the complete de-identified electronic health records of 123 patients of five neurologists of which 71 (58%) were diagnosed with ALS and 52 (42%) had ALS ruled out. It was retrospectively validated in a cohort of 117 patients of which 66 (56%) were diagnosed with ALS and 51 (44%) had ALS ruled out. The algorithm achieved a 93.9% sensitivity at a 98.0% specificity in the validation cohort.

It was subsequently evaluated prospectively against 500 consecutive patients managed by a single ALS for which ALS was not previously considered. Three patients were identified as having clinical characteristics suggestive of ALS. None of the patients identified had a definitive diagnosis for their symptoms and ALS was considered a possibility in one patient with a provisional diagnosis of primary lateral sclerosis ("PLS").

Ordering

MNd-5 analyses can be requested for individual patients ("Single Record") or whole EMR databases ("Whole Database"). Whole Database screens include all patients for which an office encounter was billed in the previous 90 days and recur every 90 days until terminated.

Requests are accepted for neurologists that maintain community or outpatient practices when:

• Placed through Compass ↗︎

• Received from within an EMR system that supports direct ordering

• Sent by email or efax (using a PDF requisition ↓)

All requests placed between the hours of 8:00am and 8:00pm Monday through Friday Eastern Time are reviewed by a member of the Clinical Operations team within 48 hours. Requests for Single Record analyses are fulfilled within 72 hours. Requests for Whole Database screens are fulfilled within 10 business days for specialists with an active integration.

Reports

Pricing

Intended Use

MNd-5 is intended for use as a decision support tool to aid qualified healthcare professionals in identifying individuals in which follow-up investigations for ALS or referral to a specialty centre may be clinically appropriate. It is not diagnostic and does not replace the independent judgment of the treating physician. Any medical diagnosis and all decisions related to patient care and treatment choices should be based on the independent judgment of the treating physician and should take into account all information related to the patient, including without limitation, the patient and family history, direct physical examination and diagnostic tests.

Regulatory

The MNd-5 algorithm is a process for converting input parameters to a likelihood estimate. It is deployed at the Toronto, Canada data lab of Ensho Health through the MNd-5 CDL Module ("CDL Module"). The CDL Module is comprised of the MNd-5 Likelihood Estimator ("Likelihood Estimator") which encodes it in software and a graphical user interface called the MNd-5 Controller ("Controller"). The CDL Module was developed to the ISO 13485:2016 standard for medical devices in compliance with Ensho’s Quality Management System.

United States

The MNd-5 CDL Module is classified as Clinical Decision Support Software according to Food and Drug Administration guidance FDA-2017-D-6569 ↗︎ on the interpretation of Section 3060(a) of the 21st Century Cures Act (Cures Act) since its input parameters are clinical characteristics recorded in patient charts at a single point in time (criterion 1-2) and it provides recommendations to healthcare professionals about diagnosis whose basis are clearly communicated (criterion 3-4).

Canada

The MNd-5 CDL Module is registered as medical device software in Canada under the Medical Device Establishment License of Ensho Health (license 16208).

Rest of World

MNd-5 is not yet available in Australia, European Union member states or Israel.