Clinical Services

Meet unmet diagnostic needs faster

Onboard your clinical NGS test with our team, ensuring your test meets regulatory and reimbursement requirements and that the assay meets your patient population needs.

Service Overview

Laboratories encounter numerous challenges in launching new tests, integrating systems, and maintaining compliance with evolving regulations. The complexities of validation, ensuring compatibility with existing EMRs, and navigating reimbursement procedures can create bottlenecks that delay patient results and disrupt operational efficiency.

Having spent 10+ years partnering with labs to start up their testing programs we have learned what it takes to be able to get going quickly. Our clinical services help you get up and running while our CGW software make it easy and efficient to scale your operation.

We offer the following services to labs:

Validation – end-to-end test validation services for compliance and regulatory approval
Technology integration – API & HL7 integrations for seamless EMR and labs system connectivity
Concierge – assistance with SOP development, training, mock audits and CAP/CLIA validations
Revenue Cycle Management (RCM) - Validation and approval processes, such as MolDX, can be overwhelming. Labs require a reliable partner to ensure their tests not only meet regulatory standards but also secure reimbursement from insurance companies—critical for long-term viability and revenue flow.

Why use Velsera’s Clinical services

Better, Faster, Simpler.

Better

Tailored solutions for exceptional outcomes

Velsera’s end-to-end laboratory support enhances the quality and precision of your workflows. From customized reports for patients and oncologists to expert guidance on SOP development, we ensure your lab delivers accurate, high-quality care with confidence.

Faster

Accelerated workflows and seamless integration

Streamline your lab’s operations with optimized software configuration, API and HL7 integrations, and EMR connectivity. These solutions enable faster turnaround times and more efficient delivery of results to patients and clinicians.

Simpler

Effortless compliance and operational efficiency

Simplify regulatory complexities with concierge services that cover CAP/CLIA validations, MolDX approvals, and audit readiness. Our expert team ensures your lab achieves compliance while improving workflows for greater operational impact.

Who we help accelerate

Customers for service

Clinical Diagnostic Laboratories

Accelerate the scale-up of your NGS testing

Grow revenue by expanding your NGS business. Velsera helps diagnostic labs rapidly establish and grow new, profitable NGS revenue streams. With our support, we can help your lab get up-and-running with an existing on-market assay (20+ LDT & IVD options available), including support for validation, revenue cycle management, and our Clinical Genomics Workspace (CGW) software to aid clinical decision-making.

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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.

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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.

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Solutions

Solutions this service supports

Clinical Interpretation & Reporting

ACCELERATE THE SCALE-UP OF YOUR NGS TESTING

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NGS Assay Development & Expansion

DEVELOP NEW TESTS TO MEET UNMET NEEDS

Has your lab recognized an unmet need in the market? Velsera helps ambitious diagnostic labs generate revenue by creating, integrating, hosting and/or deploying custom-developed NGS analysis pipelines. Additionally, we help with validation and regulatory support to ensure compliance, as well as Revenue Cycle Management support to enable reimbursement. Optionally, tertiary CGW reporting is available to create a fully integrated secondary & tertiary analysis package for your test.

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IVD Compliance Transition

NAVIGATE REGULATORY UNCERTAINTY

Don’t let compliance challenges impede your progress. Velsera assists labs 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.

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Companion Diagnostic Development & Scaling

ACCELERATE UPTAKE OF YOUR UPCOMING LAUNCH

Explore this solution

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