LaunchDx

LaunchDx

Launch at-home diagnostic tests faster with expert support in FDA strategy, remote clinical validation, and digital health integration.

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LaunchDx

Launch at-home diagnostic tests faster with expert support in FDA strategy, remote clinical validation, and digital health integration.

Request Demo

Your Path To Market

Your Path To Market

Your Path To Market

up to

0%

Faster Regulatory Approval

Faster

Launch

Reduce clinical trial timelines with expert regulatory and clinical strategy support.

$0B

Projected

Market Size

Improve patient experience through digital & telehealth tools.

0%

of patients

Trust At-Home

Testing

Build credibility and boost adoption with user-centered design.

What Sets LaunchDx Apart

What Sets LaunchDx Apart

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Better User Experience

Digital tools for testing, telehealth, and patient engagement.

Digital tools for testing, telehealth, and patient engagement.

Smarter Decisions

Real-time data for product improvements.

Real-time data for product improvements.

Clinical Trial Cost Reduction

Lower costs through smarter design and virtual tools.

Lower costs through smarter design and virtual tools.

Reliable Distribution

Logistics built for direct-to-consumer delivery.

Logistics built for direct-to-consumer delivery.

Regulatory Confidence

Expert guidance for faster approvals.

Expert guidance for faster approvals.

Continuous Improvement

Post-launch analytics and compliance tracking.

Market Fit Discovery

Market Fit Discovery

Build smarter, not broader.

We help you validate demand, define your target audience, and sharpen your value proposition, ensuring you’re solving the right problem for the right people before investing in development.

Market validation confirms real demand with data-backed insights.

Customer segmentation identifies exactly who your early adopters are.

Competitive positioning clarifies how you’re better, not just different.

Roadmap alignment prioritizes high-impact features and opportunities.

Go/no-go confidence helps you move forward or pivot with purpose.

Regulatory Roadmapping

Regulatory Roadmapping

Build a clear path to FDA submission.

We help you navigate complex regulatory requirements with a customized strategy that fits your product, timeline, and goals. From initial planning to documentation, we set your trial up for success from day one.

Strategic regulatory planning to align your product with the right FDA pathway.

Study design guidance including protocol development and validation strategy.

Comprehensive risk and gap assessments to identify challenges early.

Pre-submission and Q-Sub support to ensure smooth FDA communication.

Clinical Trial Execution

Clinical Trial Execution

Remote trials, simplified from start to finish.

LaunchDx streamlines every phase of your clinical study, from enrollment to test monitoring and data reporting. Our tools are designed to reduce site burden, speed up timelines, and ensure data quality, while making participation easier for users at home.

AI-powered consent for fast, secure identity verification and e-signature.

Remote test proctoring with video-based monitoring and real-time support.

Automated reporting to track progress, analyze trends, and export data effortlessly.

Go-To-Market Execution

Go-To-Market Execution

Turn your strategy into sales.

We help you refine the final pieces of your launch strategy, ensuring your message resonates, your pricing holds up, and your sales funnel converts.

Message testing ensures your value proposition lands with real customers.

Pricing and reimbursement strategy makes your offer defensible and fundable.

Sales enablement equips teams or partners to confidently drive adoption.

Website and digital presence turn interest into action across all touch points.

Funnel design builds a scalable path from awareness to conversion.

Post-Market Monitoring

Post-Market Monitoring

Real-world insights that power continuous improvement.

Once your test is live, LaunchDx helps you track performance, uncover trends, and stay ahead of issues. Our platform turns real-world data into actionable insights supporting compliance, quality control, and future innovation.

Real-world data insights including usage rates, invalidity rates, and positivity vs. prevalence.

Streamlined regulatory compliance through automated tracking.

Built-in public health reporting to support broader impact.

User feedback collection including satisfaction surveys and NPS scoring.

Smarter iteration cycles backed by ongoing performance data.

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Get in Touch

Get in Touch

Get in Touch

Have a question or need support? We're here to help!

Have a question or need support? We're here to help!

Launch With Confidence

From validation to distribution, we power your path to market.

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