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NGS ASSAY & EQUIPMENT MANUFACTURERS
Grow your assay business by partnering with Velsera and leverage over a decade of experience partnering with some of the world’s leading labs, assay & equipment manufacturers to bring new tests to market
The challenges & opportunities facing NGS Assay Manufacturers
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 run effective diagnostic testing programs. For equipment and assay manufacturers to be successful they must understand what the challenges are and then design great products - supported by services and technology – that the market can easily adopt and scale. We see two primary challenges for labs that manufacturers need to design for in order to be successful:
Getting started.
The first challenge comes from just getting started. The complex workflow, specialist skills required and myriad of equipment and test options available can all be barriers to a lab deciding to run NGS in-house. Without the proper support we have seen labs take 1-2 years to get started, often failing validation multiple times and struggling to get reimbursed for more than 30% of tests they run. However, with the right support and guidance we have seen startup times cut by more than 50% and reimbursement rates significantly increase.
Scaling up.
Even once a lab is up and running the second challenge comes in scaling the operation. The highly complex workflow coupled with specialist training required mean that often scarce resources become the bottleneck to growth. We believe that with the right technology, coupled with tried-and-tested SOPs and workflows the efficiency of the operation can be dramatically increased, removing barriers to growth
Why partner with Velsera
Better
Our 10+ years' experience helping clinical diagnostic labs to develop and scale tests coupled with 10+ years working with researchers on cutting-edge bioinformatics enable us to partner with you to provide the analytics (secondary and/or tertiary) needed to bring a great test to market.
Faster
Our regulatory experts can help you cut through the complex challenges of bringing a new test to market, while our clinical experts can provide insight into the common challenges that labs need to overcome so you can design a better test that is adopted faster.
We understand and have the technical expertise to implement the regulatory requirements associated with ISO 13485 and ISO 27001.
Our tertiary analytics software is already in wide-use globally, further accelerating your scale-up speed by leveraging our existing clinic network and providing them a test which they already know how to report on.
Simpler
Our teams of experts can help make it easier for your customers to start using your new test. We can deploy our clinical services group to provide critical services (e.g., validation, SOP writing, RCM) that make it quick and easy for a customer to get going.
Solutions
NGS Assay Development & Expansion
Have you got a promising diagnostic test in development? Or have you got some novel sequencing equipment that you think can benefit diagnostic labs? Velsera can partner with you to bring new, promising tests to market by creating, integrating, hosting and/or deploying custom-developed NGS analysis pipelines. Additionally, we can help labs with validation and regulatory support to ensure compliance, as well as Revenue Cycle Management support to enable reimbursement – increasing the uptake from customers.
Optionally, tertiary CGW reporting is available to create a fully integrated secondary & tertiary analysis package for your test.
IVD Compliance Transition
Have you already developed a valuable LDT and now you want to take it through the IVD certification process? Don’t let compliance challenges impede your progress. Velsera assists assay manufacturers in navigating the FDA clearance process for both new assays and existing Laboratory Developed Tests (LDTs). We provide the necessary “dry-lab” component for approved products, along with optional tertiary reporting to enhance your workflow.
Technology
Services
Our clinical experts have all the tools to help your customers to 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.
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.
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
“Velsera has been a great partner enabling our NGS offering so we can improve the quality and speed of patient care. With Velsera's team and technology, we have been able to streamline our workflow and customize our clinical report. We can run various assays using the single Velsera platform. And our physicians are highly complementary of the report we created with Velsera given the content and aesthetic.”
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Schedule a personalized demo today to discover how our expertise can help you deliver more tailored care and improve outcomes for patients worldwide.