The molecular diagnostics market is experiencing rapid growth largely due to advances in genetics / genomics / proteomics technologies over the last decade that have enabled significant discoveries to be made in predictive biology. Commercial companies are now emerging with new tests in combination with proprietary algorithms to make useful predictions for patients.
In order to commercialize these tests, a Molecular Dx company will typically establish a lab for sample processing and assessment. In order for US based labs to conform with regulations, the entire process from sample receipt to processing needs to be compliant with CLIA regulations.
MDx Company Requirements
Molecular Dx labs have a diverse set of information technology needs that span well beyond what is traditionally thought of as lab management. All or some of the following are often needed:
- An ordering system for physicians to enter test requests, or a method to interface with existing physician systems to receive orders
- Sample Collection Kit Management
- Sample Management
- Lab Workflow Tracking – i.e. Electronic Lab Notebook
- Instrument Integrations for Lab Automation
- Assay Data Management and Custom Algorithm Implementation
- Automated Diagnostic Report Creation with E-signature
- Medical Billing
- Sales Force Automation Integration
This extent of this list is daunting for a new MDx company to consider as a thorough implementation of these features could require four or more software solutions and years of work. New labs also need to get CLIA certification and may also need to operate under GLP and/or be a validated lab per FDA Part 11 specifications.
Exemplar Dx LIMS - From Test Request to Results
Sapio Sciences has extensive expertise in implementing fully electronic (i.e. paperless), compliant systems at leading MDx companies. Exemplar Dx can manage all the items listed above within a single solution, and it does this in contracted timeframes without sacrificing features or functions. This means your lab can be up and running and processing orders quickly in a compliant setting.
Sapio has achieved implementation timeframes of as little as 2 months from start to finish with complete tracking from request to results. Sapio is able to do this because its Exemplar Laboratory Management System's foundational technology platform enables detailed, customized processes to be implemented rapidly, so not only is the implementation done quickly, it adheres to your specific requirements. Sapio is also able to make the process 100% paperless from test request through sample processing and results generation, which streamlines the workflow from beginning to end and ensures compliance with upcoming changes in CLIA regulations that may mandate paperless processes.
Sapio Sciences - Your Experienced Partner in Discovery for Clinical Sample Processing
Sapio Sciences has industry best experience in clinical implementations via our marquee list of clients who have commercialized 'omics-based tests. Sapio understands CLIA/CAP/HIPAA requirements and our Exemplar technology meets all the key regulatory requirements. We have both strong partnerships and integration experience with companies in the clinical space:
- N-of-One – Technical integration and partnership with N-of-One for interpretation of genomic data so physicians can properly understand the data from the new NGS based assays
- Server General – Protecting sensitive patient data is fundamental to clinical implementations. To that end, Sapio has partnered with Server General to enable robust data protection via encryption to ensure that protected health information of your patient data is properly secured
- Billing Providers – Sapio has also integrated with top billing providers to automate payment processing at the proper time in the processing pipeline
- Sales Force Automation Integration – Exemplar has been integrated with leading SFA companies for entering and tracking orders
The combination of Exemplar LIMS\ELN compliance and capabilities, our broad experience in the clinical space and our clinical solution partner relationships make Sapio the ideal solution for your MDx company.
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