COVID Diagnostic Monitoring System - See More Features

Automated Bioinformatics Platform for Tracking COVID Variant Impacts to Diagnostic Tests

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ROSALIND DxM uniquely empowers rapid, ongoing in-silico and in-vitro analysis against the latest viral variants

Developed in collaboration with the National Institutes of Health RADx Tech Initiative and the National Institute of Biomedical Imaging and Bioengineering

Supports PCR, LAMP, FISH, Antigen and CRISPR assays

Integrates BioBank sample management and wet-lab verification, including optimized sample selection based on mutation, incident or clinical trial

Explore the impact of nucleotide, amino acid, and protein changes

International sequence data enabled by GISAID

ROSALIND DxM enables a consistent, repeatable process to test any diagnostic test against viral variants

Bioinformatic pipelines and melting temperature algorithms developed and tuned in collaboration with the FDA

Updates daily with global sequence data for all tracked diagnostic incidents

Provides actionable data to refine the development of diagnostic tests

Facilitates multi-site collaboration with secure data sharing

Streamline regulatory submissions and requests for variant validation

Setup new diagnostic tests and review detailed incident reports within minutes

Supports PCR, Antigen, LAMP, FISH and CRISPR-based diagnostic tests

Enables secure entry and encryption of assay parameters such as primer sequences, oligos and guide RNAs

Integration of the Open COVID-19 primers and probes enables immediate exploration of incidents with these public tests

Detailed readme and configuration files streamline test setup and modification

The Incident Table summarizes all incident mismatch events using consistent severity scoring and dynamic filters to focus on the most significant variants of concern

Incidents are ranked by severity and frequency

The severity score evaluates multiple factors, including number of nucleotide changes, any insertions or deletions, change in melting temperature as well as incident frequency and ranges from 0 (low) to 5 (high)

A 30, 60 and 90-day view shows incident frequency as a percentage and count

Adjust severity and frequency sliders to filter and focus on incidents of interest

Toggle geographic regions to explore coverage and incident events based on geographic sequence variations

Rapidly sort results by clicking any column or dragging to resize and reorder columns

Click on any incident to open incident details for trends and strain level insights.

Incident Detail summarizes trended frequency data with severity metrics and the lineage evolution

Visualize and explore trends with the interactive plot while recording status changes, investigating severity and ultimately requesting wet-lab verification

Displays the estimated change in melting temperature between the primer and incident sequences

Depending on security parameters, displays incident strain mapping and mismatches to the diagnostic test

Integration with the RADx BioBank or other private sample and sequence repositories enables targeted sample and pool-based variant verification

Investigate mismatch incidents from in silico analyses and verify directly in the wetlab

Record results in triplicate with tracked audit trails

Two-step approval and verification for results

The graph-accelerated genome browser uniquely empowers instant visualization and deep exploration of any mutation or diagnostic test

Rapidly inspect primer regions and the frequency of viral mutations to identify risks and potential areas of greater stability

Adjust reference parameters to focus timeframe and geography

Enter any mutation, amino acid change, lineage, clade or geography on the comparison track to study the rapid viral evolution

Display user-entered or public tests and rapidly navigate to areas of interest

Jump to any viral gene and zoom in/out to introspect key trends and mutations

PAUSE PLAY SKIP
Highlights
Diagnostic Lifecycle
Setup Monitoring
Incident Summary
Incident Details
Wet Lab Testing
Genome Browser
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A Comprehensive Diagnostic Monitoring System

Track & Analyze SARS-CoV-2 Viral Mutations for Diagnostic Test Efficacy

WHAT IS THE DxM SYSTEM? 


Contact Us About DxM

The ROSALIND Diagnostic Monitoring system (ROSALIND DxM) is a web-based platform for monitoring the emergence of genetic variants of infectious diseases and evaluating their effects on the performance of diagnostic tests. It is currently offered to enable tracking of SARS-CoV-2 variants to support the global fight against COVID-19. 
 
The system enables test manufacturers to enter key information on their tests (for example, primer/probe sequences or antigen/epitope information) via a secure user interface. The system then automatically screens the reagents against a database of SARS-CoV-2 variant sequences to identify incidents that could disrupt the interaction between the test reagent and its target, thus impacting test efficacy. Users without bioinformatics expertise are able to easily monitor and evaluate potential risks via confidential dashboards and analysis reports. Ongoing updates ensure the system provides automated tracking and alerts for all incidents and mismatch events against the most current sequence data. An integrated and intuitive genome browser guides users in exploration of primer and variant mismatches with the ability to identify alternate primer design based on observed variability in the viral genome. 
 
ROSALIND DxM provides an intuitive user experience that enables:
  • Entry of information on tests including target regions or primers/probes for assays with the selection of test type, including Antigen, LAMP, FISH, or CRISPR assays
  • Analysis of potential risks posed by new variants on the efficacy of diagnostic assays
  • Evaluating risks in detail when they emerge and ongoing tracking as they increase in frequency 
  • Documentation and upload of data associated with wet-bench protocols responding to risk assessments and potential incidents due to the rapidly evolving viral genome
  • Generation of automatic email and/or text notifications alerting users when new mismatch incidents are identified
  • Provides robust enterprise security including single sign on integration to preserve confidentiality for all tests, test parameters, and incidents
  • Share results to facilitate confidential collaboration with internal teams, CROs, and other organizations  
  • ROSALIND DxM was developed in consultation with the U.S. Food & Drug Administration (FDA) and National Institutes of Health (NIH)

OVERVIEW


With the rapid emergence of SARS-CoV-2 variants, there is rising concern over the ability for tests to detect new viral strains using existing diagnostic assays. Diagnostic manufactures, funders, and regulators all have a vested interest in understanding these variants. The ROSALIND Diagnostic Monitoring System [ROSALIND DxM] provides the following:
  • Secure, scalable web-based System
  • Intuitive User Interface with Protection of Proprietary Test Information
  • Advanced Analysis to Assess and Manage Risk
  • Diagnostic Coverage and Mismatch Incident Dashboards
  • Integrated Bioinformatics pipeline with daily updates enabled by GISAID

ROSALIND DxM for Test Manufacturers


ROSALIND DxM enables manufacturers of SARS-CoV-2 diagnostic test kits to design and monitor tests based on the latest information on emerging variants. DxM can be used to evaluate new primer sequences against known variants, then automatically monitor sequences over time to support post-market surveillance. DxM also streamlines the preparation of inclusion and exclusion reports in support of Emergency Use Authorization submissions. 

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"We understood right from the start that diagnostic manufacturers and agencies needed an intuitive platform where they could define their tests and immediately detect potential issues against all available sequence data."

eric-lai-cicle

Eric C. Lai, PhD

RADx Tech Variant Taskforce

HIGHLIGHTS

EASE-OF-USE

ROSALIND DxM provides an intuitive user interface that does not require specialist training in bioinformatics

CONTINUOUS RISK MONITORING

ROSALIND DxM is continuously updated with the latest strain sequences and performs queries against diagnostic reagents daily to identify potential risks

AUTOMATED ALERTS

Whenever an incident of potential impact to test reagents is identified, ROSALIND DxM automatically alerts key stakeholders as defined by the administrator

POWERFUL DASHBOARDS

Dashboards allow for high-level assessment of all risk incidents for a given set of reagents and then drill into incidents to understand them in detail and learn how to design around them

CONTROLLED PERMISSIONS

Company administrators control who has access to information on test reagents within DxM

TRUSTED PIPELINES BUILT-IN

Built-in pipelines are tuned to utilize industry standard, widely published bioinformatics tools. For more information, review the ROSALIND specifications and method section

SECURITY AND ENCRYPTION

Every communication and data transfer on ROSALIND is encrypted and secured. Multiple layers of data protection ensure availability

FREQUENTLY ASKED QUESTIONS


faqPerson cube2b

What types of diagnostic tests are covered by the SARS-CoV-2 DxM Portal?

faqROSALIND

The DxM Portal supports most nucleic-acid and antigen based tests for SARS-CoV-2, including PCR, LAMP, FISH, Antigen and CRISPR tests.

faqPerson cube2b

What is required to set up the DxM to monitor my primer/probe sequence?

faqROSALIND

Simply sign up for a DxM subscription and upload key details of your assay. The DxM will then begin automatically monitoring for incidents that may impact the performance of your assay.

faqPerson cube2b

How will I know if the DxM identifies an issue with my assay/reagents?

faqROSALIND

The DxM is an automated monitoring system. When a new risk is identified, it generates an automated text and/or email alert to notify all stakeholders that are defined by the assay manufacturer. The DxM also provides access to reports and dashboards summarizing potential issues.

faqPerson cube2b

Who is notified when a potential issue with my reagents is identified?

faqROSALIND

Diagnostic manufacturers control who has access to information and alerts about their tests. Information will only be shared with those designated by the manufacturer and any associated agreements.

faqPerson cube2b

How does the DxM Portal evaluate the risk that primer/probe annealing will be impacted by a variant (or collection of variants)?

faqROSALIND

The DxM performs daily queries of primer/probe sequences against our growing database of variants and calculates the change in predicted annealing temperature between the perfect match and variant sequences.

faqPerson cube2b

What if wet lab testing shows that a predicted risk does NOT actually impact the performance of the assay?

faqROSALIND

The DxM enables diagnostic manufacturers to add information on wet-lab testing to augment the assessment of risks.  If a risk is identified in silico and shown to be a non-issue via wet lab testing, users can enter this information and it will be reflected in DxM reports and dashboards.

faqPerson cube2b

How do I know that proprietary details of my assay will not be divulged to other parties?

faqROSALIND

ROSALIND’s cloud infrastructure conforms to multiple industry standards to ensure data privacy and security including FAIR and HIPAA.  A central design principle for the DxM is the ability for assay manufacturers to control who has access to information about their assay.

faqPerson cube2b

How do I get access to the SARS-CoV-2 DxM?

faqROSALIND

You may purchase a subscription directly from ROSALIND to gain access to the DxM.  

Supporting the International Response to COVID Variants for a healthier tomorrow 

Learn More About ROSALIND DxM

Schedule a briefing with our team to learn how DxM can help manage risks associated with COVID variants

Rosalind DxM Quick Start Guide best-of-show
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