Algorithm

SD-9 generates probabilistic estimates of Still's and other IL-1 mediated autoinflammatory diseases using data extracted from electronic health records. It calculates a numeric score and correlates it to the likelihood of disease based on its distribution in a reference population. The algorithm is applied to input parameters extracted by members of the Ensho Health Clinical Operations Team using the Apollo aEDC system. Patients with seropositive lupus, seropositive rheumatoid arthritis, a history of malignancies or other inflammatory or autoinflammatory conditions that could explain their symptoms are excluded.

Ordering

SD-9 analyses can be requested for individual patients ("Single Record") or whole electronic medical record 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 through Compass.

Requests for analyses can be made to eligible data labs by rheumatologists and immunologists:

• Through Compass ↗︎

• From within an EMR system that supports direct ordering

• By email or efax (using a PDF requisition ↓)

All requests placed between the hours of 8:00am and 8:00pm Monday through Friday 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.

Reports

Comprehensive reports ↗︎ are prepared and distributed for each patient with an elevated probabilty of Still's disease. Each report includes:

• A summary of the results

• A clinical interpretation of the findings

• A recommended course of action

• Corroborating or conflicting signs and symptoms

• Findings from any relevant investigations

Reports are made available online in HTML and PDF formats through Compass. Requesting physicians and office staff are notified of new results by email.

Pricing

Intended Use

SD-9 is intended for use as a decision support tool to aid qualified healthcare professionals in identifying individuals whose clinical histories are consistent with Still's and related IL-1 mediated autoinflammatory diseases. 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 SD-9 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 SD-9 CDL Module ("CDL Module"). The CDL Module is comprised of the SD-9 Likelihood Estimator ("Likelihood Estimator") which encodes it in software and a graphical user interface called the SD-9 Controller ("Controller"). The CDL Module is deployed exclusively at the Toronto Data Lab of Ensho Health where it is applied to the data of requesting physicians as a service. 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 SD-9 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 health care professionals about diagnosis whose basis are clearly communicated (criterion 3-4).

Canada

The SD-9 CDL Module is registered as medical device software in Canada under the Medical Device Establishment License of Ensho Health (license 16208).

Rest of World

SD-9 is not yet available in Australia, European Union member states or Israel.