NGS ASSAY DEVELOPMENT & EXPANSION

The next generation of NGS

Whether you’re building a new assay or expanding an existing one, Velsera has the tools and expertise to make it happen. Need a home for your current solution? No problem. Want to integrate with a collaborator’s system and connect it to CGW for tertiary analysis? We’ve got you covered. With Velsera, NGS assay manufacturers can easily host their solutions within our platform, giving customers streamlined access and support all in one place.

The challenges & opportunities in developing NGS assays

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. Access to better, simpler tests can help accelerate this and overcome many of the barriers labs have to getting going.

Whether you’re a lab looking to commercialize a test you have already developed or a manufacturer looking to sell into labs we have the technology, expertise and commercial models to partner effectively with you. We are equally at home working in an LDT as an IVD setting and can help you develop a great test and then help you to commercialize it by using our clinical teams to on-board and get new customers going.

The solutions we provide:

LDT development

Develop your own Laboratory tests, partnering with Velsera to provide secondary and/or tertiary analysis supported by our best-in-class Knowledge Base.

IVD development

Develop your own tests and partner with Velsera to take them through IVD certification, leveraging Velsera’s secondary and/or tertiary analysis supported by our best-in-class Knowledge Base.

IVD ‘expansion’

Provide your customers with additional information on your validated biomarkers using Velsera’s best-in-class Knowledge Base.

Why partner with Velsera

Better, Faster, Simpler.

Better

Knowledge of what it takes to design and scale NGS diagnostics

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

Speed up time to market and accelerate growth at launch

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

Make it easier for your customers to use your test

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.

Who we help accelerate

Customers for this solution

Clinical Diagnostic Laboratories

Develop new revenue streams by commercializing your tests

Have you got a promising diagnostic test in development? Velsera can partner with you to bring new, promising tests to market by creating, integrating, hosting and/or deploying custom-developed NGS analysis pipelines on Seven Bridges. Additionally, we can help your future laboratory customers 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.

NGS Assay & Equipment Manufacturers

Bring new tests and equipment to market

Have you got a promising diagnostic test in development? Or do you have novel equipment that you want to drive uptake of in the clinical setting? 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 your future laboratory customers 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.

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

“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.”

Jen Gass

Associate Director, Genetics Laboratory / Florida Cancer Specialists

Request a personalized demo today

Ready to see how our cutting-edge technology can revolutionize your precision medicine, clinical genomics, or health data analytics programs?