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On December 12, 2024 | By Jovan Babic
COMPANION DIAGNOSTIC DEVELOPMENT & SCALING
Better testing =
better drug launch
As more niche and higher-cost therapies come to market there is an increasing requirement for validated companion diagnostics to confirm the patient is likely to be responsive to the drug before embarking on a costly course of treatment. Your companion diagnostic therefore becomes your rate limiting factor in scaling – put simply, the faster people are able to access tests, the faster decisions can be made and patients can benefit from your new therapy.
The challenges & opportunities in developing companion diagnostics
Despite it being widely known that companion diagnostics will be required for many new drug launches, their development is often thought about late in the day, resulting in a scramble to get a test developed so as not to delay launch. This can lead to a sub-optimal test which may impact the ability of labs to start testing.
At Velsera we have over a decade of working with labs to develop and scale tests. We know what it takes to make it easy to get going and ramp up. By partnering with Velsera you can leverage this vast knowledge as well as our expertise in developing IVD grade software to design a test that minimizes friction and maximises your chance of launch success.
We have everything you need under one roof:
- Bioinformatic services – to help develop your secondary pipeline
- Regulatory services – to help you navigate approval complexities
- Clinical services – to help on board labs and scale once launched
- Secondary analytics – offered via our Seven Bridges platform
- Tertiary analytics – offered via our Clinical Genomics Workspace platform
- IVD-grade Knowledge Base – as used already in companion diagnostics (Illumina TSO Comp)
- Pangenome reference genomes – to help you develop targeted diagnostics for specific patient sub-populations
We offer a highly flexible approach to tailor our solution to your specific needs.
Why partner with Velsera
Better, Faster, Simpler.
Better
Knowledge of what it takes to design and scale NGS diagnostics
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
Biotech & Pharma
Accelerate uptake of your upcoming launch
Don’t wait until the last minute to design and develop your Companion Diagnostic (CDx) – it literally is the rate limiting gate keeper to scaling your new therapy! Velsera can partner with you to design and develop your test by creating, integrating, hosting and/or deploying custom-developed NGS analysis pipelines. Additionally, once live in the market, 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.
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 your customers 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
“Interpreting large-scale, complex transcriptomics data is critically important for understanding the molecular and cellular basis of disease. We are confident that by working with the unique multi-cloud technology developed by Velsera and by benefiting from the depth and breadth of their expertise in bioinformatics and cloud computing, these solutions will assist us in maximizing the value of the data we generate.”
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