Your lab, inside ours · CLIA · CAP

PodLabs

A dedicated laboratory suite inside the ResearchDx facility, branded in your company name, with its own CLIA certificate and CAP accreditation. Use our facilities, equipment, staff and expertise to fast-track commercialization, without the upfront cost or overhead of building a lab.

What is a PodLab?

Your own clinical laboratory, without building one

A PodLab is dedicated bioincubator space within our facility in Irvine, California. Because it is a separate suite, it can hold its own CLIA certificate and CAP accreditation, in your company’s name.

ResearchDx manages the laboratory for you: licensing, accreditation, quality and day-to-day operations. Your PodLab draws on our shared facilities, instruments, staff and expertise, so you can launch your test sooner and spend your capital on your product.

Your name on the door

A separate suite branded as your laboratory, for your clients, partners and investors.

Your own CLIA and CAP

A CLIA certificate and CAP accreditation held by your laboratory, managed by ResearchDx.

Our infrastructure

Facilities, equipment, staff and regulatory expertise already in place from day one.

What you get

Everything a clinical laboratory needs

A PodLab gives you the standing of an independent laboratory, with the resources of an established one.

Dedicated suite

A separate laboratory space for your tests, workflows and samples, inside our facility.

Your brand

The suite, and the laboratory behind it, carry your company name.

Licensing and accreditation

We obtain and maintain your CLIA certificate and CAP accreditation, plus state licensure where required.

Shared facilities and equipment

Access to our instruments, sample receiving, storage and supporting laboratory infrastructure.

Staffing your way

Run by ResearchDx staff, or by a combination of ResearchDx and your own staff.

Quality management

Quality systems, proficiency testing, inspection readiness and regulatory oversight, managed by our team.

Staffing models

Run it the way that suits your team

Fully managed

ResearchDx staff

Best for

Companies that want to focus on product, sales and partnerships while we run the laboratory

How it works

Our laboratory director, scientists and technologists operate your PodLab under your CLIA certificate

How it works

From agreement to patient results

1

Scope

Define your test menu, expected volume, staffing model and timeline.

2

Set up your suite

Prepare and brand your dedicated space, and allocate the equipment your tests need.

3

License and accredit

Apply for your CLIA certificate, CAP accreditation and any state licenses, managed by our team.

4

Validate and launch

Transfer and validate your tests to CLIA/CAP standards, then begin reporting patient results.

5

Operate and grow

Run day to day with our support, add tests, and scale with your volume.

Is a PodLab right for you?

PodLabs are best for companies with a strong product that want to fast-track commercialization without the upfront cost and overhead of their own facility.

Who it’s for

A faster, leaner route to market

Building a CLIA laboratory means finding space, buying equipment, hiring a laboratory director and staff, and working through licensing and accreditation before the first patient result. A PodLab puts that infrastructure in place for you.

You keep your own laboratory identity and certificates, and can move to your own facility later if you choose.

Launch your laboratory, inside ours.

Tell us about your product, your test menu and your timeline, and we’ll show you how a PodLab could work for you.