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On December 12, 2024 | By Jovan Babic
IVD COMPLIANCE TRANSITION
Embrace change
The regulatory landscape is always changing. Velsera can help you adapt.
The challenges & opportunities in today’s changing regulatory environment
Over the past 10+ years’ NGS testing has rapidly grown to become a mainstay of advanced clinical care. However, despite the relatively established practice many Clinical Laboratories struggle to scale-up effective diagnostic testing programs. Recent changes in regulations in the US are creating a further complexity as Clinical Laboratories and Assay Manufacturers try to work out how to navigate the transition from Laboratory Developed Tests (LDTs) to FDA authorized In Vitro Diagnostic (IVD) tests.
In particular labs are grappling with how they transition tests currently run as LDTs to in future be compliant IVDs. Velsera has already been on this journey and already has software included in approved diagnostic tests (e.g., Illumina’s TSO Comp). Our clinical, regulatory and bioinformatic experts - supported by our IVD-grade software – can help you navigate this transition effectively.
Velsera can partner with you to help you take tests you have already developed through regulatory approval processes, supported by our IVD grade software to provide secondary and/or tertiary analytics supported by our best-in-class Knolwedge Base.
Why partner with Velsera
Better, Faster, Simpler.
Better
IVD-Grade knowledgebase at your fingertips
Our approach to clinical evidence collection, aggregation, and assembly focuses on a higher standard of quality, richer depth, and better curation than any of our competitors. In this area, we are in a class of one. Our KB is already part of an FDA-approved diagnostic test (Illumina’s TSO Comp) and so we know what it takes to meet IVD regulations.
Faster
Accelerate your approval
Our expert teams know what it takes to get approval and can use our prior experience to help guide you through the complex approval process.
Simpler
By your side, with experts and cutting-edge technology
Having gone on this journey before we have many components off the shelf, including IVD-grade software. Don’t re-invent the wheel, let us help you to take tried-and-tested technology to simplify the complex approval process.
Who we help accelerate
Customers for this solution
Clinical Diagnostic Laboratories
ACCELERATE THE SCALE-UP OF YOUR NGS TESTING.
Changes in regulation often cause concern and risk of disruption. However we see this as an opportunity to gain first-mover advantage. Work with us to quickly transition and maintain your volumes allowing you to accelerate growth as others lag in their own transitions.
Technology
Applicable technology platform components within this solution package
Services
Applicable expert service components within this solution package
CLINICAL SERVICES
Our clinical experts have all the tools to help you get up and running with NGS quickly, including – clinical validation, SOP writing, Revenue Cycle Management (RCM) & re-imbursement support, mock-audits, on-site go-live support, IT integration, implementation and project management.
REGULATORY SERVICES
Our experienced team has many years of experience working with regulatory bodies (e.g., CLIA, FDA etc.), enabling us to develop advanced offerings to guide you through the process of achieving regulatory approval as quickly and efficiently as possible
BIOINFORMATICS SERVICES
Our experienced team of in-house bioinformaticians can help with any aspect of bioinformatics support including augmenting your internal teams to develop market leading analysis pipelines.
Real-world impact, trusted partnerships
“The Clinical Genomics Workspace (CGW) by Velsera has provided our laboratory with a seamless, integrated software solution that allows us to spend more time analyzing the sequencing data and generating clinical reports and less time worrying about logistics.”
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